CompletedNCT03848845DREAMM 4Updated Apr 9, 2024Results posted

Study Evaluating Safety, Tolerability and Clinical Activity of GSK2857916 in Combination With Pembrolizumab in Subjects With Relapsed/Refractory Multiple Myeloma (RRMM)

A Phase 1/2 interventional study of belantamab mafodotin and Pembrolizumab in Multiple Myeloma, sponsored by GlaxoSmithKline. Completed at 12 sites in 4 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-04-09.

Sponsored by GlaxoSmithKline · Phase 1/2, Interventional, and Treatment

Phase: Phase 1/2
Study type: Interventional
Enrollment: 41
Allocation: Non-randomized
Ages: 18 Years and older
Sex: All

Study summary

This is a phase I/II, single arm, open label, two-part study that will assess safety, tolerability and clinical activity of GSK2857916 given in combination with a programmed cell death-1 (PD-1) inhibitor pembrolizumab in subjects with RRMM. This study will enroll adult subjects with RRMM, who have undergone stem cell transplant or who are considered transplant ineligible. Part 1 is a dose escalation phase to evaluate the safety and tolerability of escalating doses of GSK2857916 in combination with 200 milligrams (mg) pembrolizumab to establish the recommended phase 2 dose (RP2D). The following dose levels of GSK2857916 are planned to be studied: 2.5 milligrams per kilograms (mg/kg) (dose level [DL] 1) and 3.4 mg/kg (DL2). Part 2 is a dose expansion cohort. Once the RP2D has been identified, an expansion cohort will open for enrolment to confirm the safety profile and to evaluate the clinical activity of the combination. Up to 40 evaluable subjects will be enrolled in this two-part study (up to 12 in Part 1, and 28 in Part 2).

Conditions studied

Multiple Myeloma

Browse trials for

Multiple Myeloma 3,712

Keywords

GSK2857916, Pembrolizumab, Multiple Myeloma, RP2D

In context

Multiple Myeloma

3,712 studies on the registry are indexed under Multiple Myeloma; 752 are open to participants now.

This study's enrollment of 41 is close to the median of 41 across 2,965 interventional studies indexed under Multiple Myeloma.

Browse Multiple Myeloma studies →

Lead sponsor

GlaxoSmithKline is the lead sponsor of 3,647 studies on the registry; 118 are open to participants now.

Of its 264 completed or terminated interventional studies of FDA-regulated products, 239 (91%) have results posted.

Browse GlaxoSmithKline studies →

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 18 Years and older
Sexes eligible: All
Accepts healthy volunteers: No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

Provide signed written informed consent, which includes compliance with the requirements and restrictions listed in the consent form.
Male or female, 18 years or older (at the time consent is obtained).
Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
Subjects must: have histologically or cytologically confirmed diagnosis of Multiple myeloma (MM), as defined by IMWG, 2014 and has undergone stem cell transplant or is considered transplant ineligible, and has been treated with at least 3 prior lines of prior anti-myeloma treatments including an immunomodulatory imide drug (IMiD) (eg. lenalidomide or pomalidomide), a proteasome inhibitor (eg. bortezomib, ixazomib or carfilzomib) and an anti-CD38 antibody alone or in combination. Line of therapy are defined by consensus panel of the International Myeloma Workshop, Has measurable disease defined as one the following: a) Serum M-protein >=0.5 grams per deciliter (g/dL) (>=5 grams per liter [g/L]). b) Urine M-protein ≥200 mg/24h. c) Serum Free light chain (FLC) assay: Involved FLC level ≥10 milligrams per deciliter (mg/dL) (≥100 milligrams per liter [mg/L]) and an abnormal serum free light chain ratio (\<0.26 or >1.65).
Subjects with a history of autologous stem cell transplant are eligible for study participation provided the following eligibility criteria are met: a) transplant was > 100 days prior to study enrolment. b) no active infection(s). c) subject meets the remainder of the eligibility criteria.
Adequate organ system functions as defined by the laboratory assessments.
All prior treatment-related toxicities (defined by National Cancer Institute-Common Toxicity Criteria for Adverse Events [NCI-CTCAE], version 4.03, 2010) must be \<= Grade 1 at the time of enrolment except for alopecia and Grade 2 neuropathy.
A female subject is eligible to participate if she is not pregnant or breastfeeding, and at least one of the following conditions applies: is not a woman of childbearing potential (WOCBP) OR is a WOCBP and using a contraceptive method that is highly effective (with a failure rate of \<1% per year), preferably with low user dependency, during the intervention period and for at least 120 days after the last dose of study intervention and agrees not to donate eggs (ova, oocytes) for the purpose of reproduction during this period. The investigator should evaluate the effectiveness of the contraceptive method in relationship to the first dose of study intervention. A WOCBP must have a negative highly sensitive serum pregnancy test (as required by local regulations) within 72 hours before the first dose of study intervention. The investigator is responsible for review of medical history, menstrual history, and recent sexual activity to decrease the risk for inclusion of a woman with an early undetected pregnancy.
Male subjects are eligible to participate if they agree to the following during the intervention period and for at least 140 days after the last dose of study intervention. Male subjects should refrain from donating sperm, plus, either be abstinent from heterosexual intercourse as their preferred and usual lifestyle (abstinent on a long term and persistent basis) and agree to remain abstinent OR Must agree to use a male condom and female partner to use an additional highly effective contraceptive method with a failure rate of \<1% per year when having sexual intercourse with a woman of childbearing potential who is not currently pregnant.

Exclusion criteria

Exclusion criteria:

A subject will NOT be eligible for inclusion in this study if any of the following criteria apply:

Systemic anti-myeloma therapy or an investigational drug \<=14 days or five half-lives, whichever is shorter, preceding the first dose of study drug
Plasmapheresis within 7 days prior to the first dose of study drug
Prior treatment with a monoclonal antibody within 30 days of receiving the first dose of study drugs
Has received prior therapy with an anti-PD-1, anti-Programmed cell death Ligand 1 (PD-L1), or anti-Programmed cell death Ligand 2 (PD-L2) agent or with an agent directed to another stimulatory or co-inhibitory T-cell receptor (e.g., cytotoxic T-lymphocyte-associated antigen 4 [CTLA-4], OX 40, CD137) and was discontinued from that treatment due to a Grade 3 or higher immune related adverse event (irAE)
Current corneal epithelial disease except mild punctate keratopathy
Any major surgery within the last four weeks prior to the first dose of study therapy
Presence of active renal condition (infection, requirement for dialysis or any other condition that could affect subject's safety). Subjects with isolated proteinuria resulting from MM are eligible, provided they fulfil criteria as per adequate organ system function mentioned under inclusion criteria.
Any serious and/or unstable pre-existing medical, psychiatric disorder or other conditions (including lab abnormalities) that could interfere with subject's safety, obtaining informed consent or compliance to the study procedures.
Has received prior radiotherapy within 2 weeks of start of study therapy. Subjects must have recovered from all radiation-related toxicities, not require corticosteroids, and not have had radiation pneumonitis. A 1-week washout is permitted for palliative radiation (\<=2 weeks of radiotherapy) to non-central nervous system (CNS) disease.
History of (non-infectious) pneumonitis that required steroids, or current pneumonitis
Current active liver or biliary disease per investigator assessment defined by the presence of ascites, encephalopathy, coagulopathy, hypoalbuminemia, esophageal or gastric varices, persistent jaundice, or cirrhosis.
Malignancies other than disease under study are excluded, except for any other malignancy from which the subject has been disease-free for more than 2 years and, in the opinion of the principal investigators and GSK Medical Monitor, will not affect the evaluation of the effects of this clinical trial treatment on the currently targeted malignancy (RRMM). Subjects with curatively treated non-melanoma skin cancer are allowed.
Has known active CNS metastases and/or carcinomatous meningitis. Subjects with previously treated brain metastases may participate provided they are radiologically stable, i.e., without evidence of progression for at least 4 weeks by repeat imaging (note that the repeat imaging should be performed during study screening), clinically stable and without requirement of steroid treatment for at least 14 days prior to first dose of study therapy
Evidence of cardiovascular risk including any of the following: a) corrected for heart rate by Fridericia's formula (QTcF) interval ≥470 msecs. b) Evidence of current clinically significant uncontrolled arrhythmias; i. including clinically significant ECG abnormalities including 2nd degree (Type II) or 3rd degree atrioventricular (AV) block. c) History of myocardial infarction, acute coronary syndromes (including unstable angina), coronary angioplasty, or stenting or bypass grafting within six months of Screening. d) Class III or IV heart failure as defined by the New York Heart Association functional classification system. e) Uncontrolled hypertension. f) Presence of cardiac pacemaker (or defibrillator) with a predominantly ventricular paced rhythm, limiting ECG/QTcF analysis. g) Abnormal cardiac valve morphology (>=Grade 2) documented by echocardiogram (subjects with grade 1 abnormalities [i.e., mild regurgitation/stenosis] can be entered on study). Subjects with moderate valvular thickening should not be entered on study.
Known immediate or delayed hypersensitivity reaction or idiosyncrasy to drugs chemically related to GSK2857916 or pembrolizumab, or any of the components of the study treatment.
Pregnant or lactating female.
Known active infection requiring antibiotic, antiviral, or antifungal treatment.
Known Human Immunodeficiency Virus (HIV) infection.
Presence of hepatitis B surface antigen (HBsAg), or hepatitis B core antibody (HBcAb) at screening or within 3 months prior to first dose of study treatment
Positive hepatitis C antibody test result or positive hepatitis C Ribonucleic acid (RNA) test result at screening or within 3 months prior to first dose of study treatment.
Has received a live-virus vaccination within 30 days of planned start of study therapy.
Active autoimmune disease that has required systemic treatment in past 2 years (i.e. with use of disease modifying agents, corticosteroids or immunosuppressive drugs). Replacement therapy (eg, thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency, etc.) is not considered a form of systemic treatment.
Has a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy (in dosing exceeding 10 mg daily of prednisone equivalent) or any other chronic form of immunosuppressive therapy within 7 days prior the first dose of study therapy.
Has known psychiatric or substance abuse disorder that would interfere with the subject's ability to cooperate with the requirements of the study.
Has had an allogenic tissue/solid organ transplant

Study design

Phase: Phase 1 / Phase 2
Primary purpose: Treatment
Allocation: Non-randomized
Intervention model: Sequential assignment
Masking: None (open label)
Enrollment: 41 participants (actual)

Study arms

Experimental
Part 1: Dose escalation
Subjects will receive belantamab mafodotin at escalating doses of 2.5 milligrams per kilograms (mg/kg) and 3.4 mg/kg along with 200 mg pembrolizumab via intravenous (IV) infusion on Day 1 of each 21-day cycle to establish RP2D. There will be maximum of 35 cycles of combination treatment.
Drug: belantamab mafodotin · Drug: Pembrolizumab
Experimental
Part 2: Expansion cohort
Subjects will receive belantamab mafodotin at RP2D along with 200 mg pembrolizumab via IV infusion on Day 1 of each 21-day cycle. There will be maximum of 35 cycles of combination treatment.
Drug: belantamab mafodotin · Drug: Pembrolizumab

Interventions

Drugbelantamab mafodotin
belantamab mafodotin will be available as 20 milligrams per millilitre (mg/mL) solution for IV infusion, supplied as frozen liquid. belantamab mafodotin solution will be diluted in normal 0.9% saline to the appropriate concentration for the dose.
DrugPembrolizumab
Pembrolizumab will be available as 100 mg/4 mL solution that should be stored under refrigeration at 2-8 degree Celsius. Pembrolizumab injection (solution) will be diluted prior to IV administration in 0.9% sodium chloride injection or 5% dextrose injection.

What researchers measure

Primary outcomes

Part 1 - Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
An AE is any untoward medical occurrence in a clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. SAE is defined as any untoward medical occurrence that, at any dose results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect, other situations which involve medical or scientific judgment or is associated with liver injury and impaired liver function.
Time frame: Up to approximately 31 months
Part 1 - Number of Participants With Dose Limiting Toxicities (DLTs)
DLT is an AE that is considered by the investigator to be clinically relevant and attributed to the study therapy during the 21 day DLT period and meets at least one of the DLT criteria: any Grade 4 and 3 non-hematologic toxicity, any Grade 3 or greater non-hematologic laboratory value, hematologic toxicity lasting \>=7 days, except Grade 4 thrombocytopenia of any duration or Grade 3 thrombocytopenia associated with clinically significant bleeding. Grade 3 or greater febrile neutropenia lasting \>48 hours (h) despite adequate treatment, Nephrotoxicity requiring dialysis, Liver toxicity, prolonged delay (\>14 days) in initiating Cycle 2 due to any treatment (pembrolizumab or GSK2857916) related toxicity, any treatment-related toxicity that causes discontinuation of treatment during Cycle 1, any other toxicity considered to be dose-limiting that occurs beyond 21 days and any other event which in the judgment of the investigator and GlaxoSmithKline Medical Monitor is considered to be a DLT.
Time frame: Up to 21 days
Part 1 - Number of Participants With Worst-case Grade Change From Baseline in Hematology Parameters
Blood samples were collected for the analysis of following hematology parameters: hemoglobin, White blood cells (WBC) count, lymphocytes, neutrophils and platelet count. The laboratory parameters were graded according to National Cancer Institute-Common Terminology Criteria for Adverse Events (NCI-CTCAE) version 4.03. Grade 1: mild; Grade 2: moderate; Grade 3: severe or medically significant; Grade 4: life-threatening consequences. Higher grade indicates greater severity and an increase in CTCAE grade was defined relative to the Baseline grade. Baseline was defined as the most recent, non-missing value prior to or on the first study treatment dose date. Any worst-case post baseline increase in grade along with any increase to a maximum grade of 3 and a maximum grade of 4 are presented.
Time frame: Baseline (Day 1) and up to approximately 31 months
Part 1 - Number of Participants With Worst-case Change Post-baseline in Hematology Parameters
Blood samples were collected for the analysis of following hematology parameters: basophils, eosinophils, mean corpuscular hemoglobin concentration (MCHC), mean corpuscular hemoglobin (MCH), mean corpuscular volume (MCV), erythrocytes, hematocrit, monocytes, neutrophils and reticulocyte. The summaries of worst-case change from baseline with respect to normal range was analyzed for only those laboratory tests that were not gradable by CTCAE version 4.03. The number of participants with decreases to low from baseline, changes to normal or no changes from baseline, and increases to high values have been presented.
Time frame: Baseline (Day 1) and up to approximately 31 months
Part 1 - Number of Participants With Worst-case Grade Change From Baseline in Lab Chemistry Parameters
Blood samples were collected for the analysis of clinical chemistry parameters: glucose, alanine aminotransferase (ALT), albumin, alkaline phosphatase, aspartate aminotransferase (AST), blood bilirubin, calcium, creatine kinase (CPK), creatinine, gamma glutamyl transferase (GGT), magnesium, phosphate, potassium and sodium. Laboratory parameters were graded according to NCI-CTCAE version 4.03. Grade 1: mild; Grade 2: moderate; Grade 3: severe or medically significant; Grade 4: life-threatening consequences. Higher grade indicates greater severity and an increase in CTCAE grade was defined relative to the Baseline grade. Baseline was defined as the most recent, non-missing value prior to or on the first study treatment dose date. Any worst case post baseline increase in grade along with any increase to a maximum grade of 3 and a maximum grade of 4 are presented.
Time frame: Baseline (Day 1) and up to approximately 31 months
Part 1 - Number of Participants With Worst-case Change Post-baseline in Lab Chemistry Parameters
Blood samples were collected for the analysis of following chemistry parameters: calcium, carbon dioxide, chloride, direct bilirubin, protein, thyrotropin (TSH), thyroxine (T4) and triiodothyronine (T3). The summaries of worst case change from baseline with respect to normal range was analyzed for only those laboratory tests that were not gradable by CTCAE version 4.03. The number of participants with decreases to low from baseline, changes to normal or no changes from baseline, and increases to high values have been presented.
Time frame: Baseline (Day 1) and up to 31 months
Part 1 - Number of Participants With Worst-case Change Post-baseline Urinalysis Results
Urine samples were collected to assess urine glucose, protein, occult blood and ketones using dipstick method. The dipstick test gave results in a semi-quantitative manner, and results for urinalysis parameters were recorded as negative, trace, 1+, 2+, 3+ indicating proportional concentrations in the urine sample. Baseline was defined as the most recent, non-missing value prior to or on the first study treatment dose date. Result for urinalysis parameters were recorded as no change/decreased and any increase. Data for worst-case post baseline urinalysis results is presented.
Time frame: Baseline (Day 1) and up to approximately 31 months
Part 1 - Changes From Baseline in Urine Potential of Hydrogen (pH)
Urine samples were collected from participants to assess urine pH levels. Baseline was defined as the most recent, non-missing value prior to or on the first study treatment dose date.
Time frame: Baseline (Day 1) and Week 46
Part 1 - Changes From Baseline in Urine Specific Gravity
Urine samples were collected from participants to assess urine specific gravity. Baseline was defined as the most recent, non-missing value prior to or on the first study treatment dose date.
Time frame: Baseline (Day 1) and Week 46
Part 1 - Number of Participants With Worst-case Grade Change From Baseline in Vital Signs: Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP)
DBP and SBP were measured after resting for at least 5 minutes in a supine or semi-recumbent position. They were graded according to NCI-CTCAE version 4.03. For SBP: Grade 0 (\<=120 millimeter of mercury \[mmHg\]), Grade 1 (121-139 mmHg), Grade 2 (140-159 mmHg), Grade 3 (\>=160 mmHg). For DBP: Grade 0 (\<=80 mmHg), Grade 1 (81-89 mmHg), Grade 2 (90-99 mmHg), Grade 3 (\>=100 mmHg). Higher grade indicates greater severity. Baseline was defined as the most recent, non-missing value prior to or on the first study treatment dose date. Data for worst-case post baseline with any grade increase and a maximum post-baseline grade increase to Grade 3 from their baseline grade are presented.
Time frame: Baseline (Day 1) and up to approximately 31 months
Part 1 - Number of Participants With Worst-case Change From Baseline in Vital Signs: Pulse Rate and Body Temperature
Vital signs (pulse rate and temperature) were measured after resting for at least 5 minutes in a supine or semi-recumbent position. The abnormal vital sign ranges were: For pulse rate (low \<60 beats per minute \[bpm\] and high \>100 bpm); For body temperature (\<=35 degrees Celsius or \>=38 degrees Celsius). Baseline was defined as the most recent, non-missing value prior to or on the first study treatment dose date. Data for worst case change from baseline was presented as Baseline to low, Baseline to Normal or No change and Baseline to High.
Time frame: Baseline (Day 1) and up to approximately 31 months
Part 2 - Percentage of Participants With Overall Response Rate (ORR)
ORR was defined as the percentage of participants with a confirmed partial response (PR) or better (i.e., PR, very good partial response \[VGPR\], complete response \[CR\] and stringent complete response \[sCR\]), according to the International Myeloma Working Group (IMWG) Response Criteria. CR = negative immunofixation of serum and urine AND disappearance of any soft tissue plasmacytomas AND \<5% plasmacytomas in the bone marrow; sCR=stringent complete response, CR as above PLUS normal serum free light-chain (FLC) assay ratio and absence of clonal cells in bone marrow by immunohistochemistry or immunofluorescence; VGPR = serum and urine M-component detectable by immunofixation but not on electrophoresis OR ≥ 90% reduction in serum M-component plus urine M-component \<100 mg/24 h; PR = ≥50% reduction of serum M-protein and reduction in 24-hour urinary M-protein by ≥90% or to \<200 mg/24 h.
Time frame: Up to approximately 31 months

Secondary outcomes

Part 1 - Percentage of Participants With Overall Response Rate (ORR)
ORR was defined as the percentage of participants with a confirmed PR or better (i.e., PR, VGPR, CR and sCR), according to the IMWG Response Criteria. CR = negative immunofixation of serum and urine AND disappearance of any soft tissue plasmacytomas AND \<5% plasmacytomas in the bone marrow; sCR=stringent complete response, CR as above PLUS normal serum free light-chain (FLC) assay ratio and absence of clonal cells in bone marrow by immunohistochemistry or immunofluorescence; VGPR = serum and urine M-component detectable by immunofixation but not on electrophoresis OR \>= 90% reduction in serum M-component plus urine M-component \<100 mg/24 h; PR = \>=50% reduction of serum M-protein and reduction in 24-hour urinary M-protein by \>=90% or to \<200 mg/24 h.
Time frame: Up to approximately 178 weeks
Part 2 - Number of Participants With AEs and SAEs
An AE is any untoward medical occurrence in a clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. SAE is defined as any untoward medical occurrence that, at any dose results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect, other situations which involve medical or scientific judgment or is associated with liver injury and impaired liver function.
Time frame: Up to approximately 178 weeks
Part 2 - Number of Participants With Worst-case Grade Change From Baseline in Hematology Parameters
Blood samples were collected for the analysis of following hematology parameters: hemoglobin, White blood cell (WBC) count, lymphocytes, neutrophils and platelet. The laboratory parameters were graded according to NCI-CTCAE version 4.03. Grade 1: mild; Grade 2: moderate; Grade 3: severe or medically significant; Grade 4: life-threatening consequences. Higher grade indicates greater severity and an increase in CTCAE grade was defined relative to the Baseline grade. Baseline was defined as the most recent, non-missing value prior to or on the first study treatment dose date. Any worst case post baseline increase in grade along with any increase to a maximum grade of 3 and a maximum grade of 4 are presented.
Time frame: Baseline (Day 1) and up to approximately 178 weeks
Part 2 - Number of Participants With Worst-case Change Post-baseline in Hematology Parameters
Blood samples were collected for the analysis of following hematology parameters: basophils, eosinophils, mean corpuscular hemoglobin concentration (MCHC), mean corpuscular hemoglobin (MCH), mean corpuscular volume (MCV), Erythrocytes, hematocrit, monocytes, neutrophils and reticulocyte. The summaries of worst-case change from baseline with respect to normal range was analyzed for only those laboratory tests that were not gradable by CTCAE version 4.03. Baseline was defined as the most recent, non-missing value prior to or on the first study treatment dose date. The number of participants with decreases to low from baseline, changes to normal or no changes from baseline, and increases to high values have been presented.
Time frame: Baseline (Day 1) and up to approximately 178 weeks
Part 2 - Number of Participants With Worst-case Grade Change From Baseline in Lab Chemistry Parameters
Blood samples were collected for the analysis of clinical chemistry parameters: glucose, alanine aminotransferase (ALT), albumin, alkaline phosphatase, aspartate aminotransferase (AST), blood bilirubin, calcium, creatine kinase (CPK), creatinine, gamma glutamyl transferase (GGT), magnesium, phosphate potassium and sodium. Laboratory parameters were graded according to NCI-CTCAE version 4.03. Grade 1: mild; Grade 2: moderate; Grade 3: severe or medically significant; Grade 4: life-threatening consequences. Higher grade indicates greater severity and an increase in CTCAE grade was defined relative to the Baseline grade. Baseline was defined as the most recent, non-missing value prior to or on the first study treatment dose date. Any worst case post baseline increase in grade along with any increase to a maximum grade of 3 and a maximum grade of 4 are presented.
Time frame: Baseline (Day 1) and up to approximately 178 weeks
Part 2 - Number of Participants With Worst-case Change Post-baseline in Lab Chemistry Parameters
Blood samples were collected for the analysis of following chemistry parameters: calcium, carbon dioxide, chloride, direct bilirubin, protein, thyrotropin (TSH), thyroxine (T4) and triiodothyronine (T3). Baseline was defined as the most recent, non-missing value prior to or on the first study treatment dose date. The summaries of worst case change from baseline with respect to normal range was analyzed for only those laboratory tests that were not gradable by CTCAE version 4.03. The number of participants with decreases to low, changes to normal or no changes from baseline, and increases to high values have been presented.
Time frame: Baseline (Day 1) and up to approximately 178 weeks
Part 2 - Number of Participants With Worst-case Change Post-baseline Urinalysis Results
Urine samples were collected to assess urine glucose, protein, occult blood and ketones using dipstick method. The dipstick test gave results in a semi-quantitative manner, and results for urinalysis parameters were recorded as negative, trace, 1+, 2+, 3+ indicating proportional concentrations in the urine sample. Baseline was defined as the most recent, non-missing value prior to or on the first study treatment dose date. Result for uranalysis parameters were recorded as no change/decreased and any increase. Data for worst-case post baseline are presented.
Time frame: Baseline (Day 1) and up to approximately 178 weeks
Part 2 - Changes From Baseline in Urine Specific Gravity
Urine samples were collected from participants to assess urine specific gravity. Baseline was defined as the most recent, non-missing value prior to or on the first study treatment dose date
Time frame: Baseline (Day 1) and until end of treatment (up to 178 weeks)
Part 2 - Changes From Baseline in Urine pH
Urine samples were collected from participants to assess urine pH levels. Baseline was defined as the most recent, non-missing value prior to or on the first study treatment dose date.
Time frame: Baseline (Day 1) and until end of treatment (up to 178 weeks)
Part 2 - Number of Participants With Worst-case Grade Change From Baseline in Vital Signs: DBP and SBP
DBP and SBP were measured after resting for at least 5 minutes in a supine or semi-recumbent position. They were graded according to NCI-CTCAE version 4.0. For SBP: Grade 0 (\<=120 millimeter of mercury \[mmHg\]), Grade 1 (121-139 mmHg), Grade 2 (140-159 mmHg), Grade 3 (\>=160 mmHg). For DBP: Grade 0 (\<=80 mmHg), Grade 1 (81-89 mmHg), Grade 2 (90-99 mmHg), Grade 3 (\>=100 mmHg). Higher grade indicates greater severity. Baseline was defined as the most recent, non-missing value prior to or on the first study treatment dose date. An increase is defined as an increase in grade relative to Baseline grade. Data for worst-case post Baseline with any grade increase and a maximum post-baseline grade increase to Grade 3 from their baseline grade are presented.
Time frame: Baseline (Day 1) and up to approximately 178 weeks
Part 2 - Number of Participants With Worst-case Change From Baseline in Vital Signs: Pulse Rate and Body Temperature
Vital signs (pulse rate and temperature) were measured after resting for at least 5 minutes in a supine or semi-recumbent position. The abnormal vital sign ranges were: For pulse rate (low \<60 beats per minute \[bpm\] and high \>100 bpm); For body temperature (\<=35 degrees Celsius or \>=38 degrees Celsius). Participants were counted in the worst case category that their value changed to (low, normal or high), unless there was no change in their category. Baseline was defined as the most recent, non-missing value prior to or on the first study treatment dose date.
Time frame: Baseline (Day 1) and up to approximately 178 weeks
Part 2 - Number of Participants With Maximum Worst-case Change From Baseline in Best Corrected Visual Acuity Test (BCVA) Scores
BCVA score was calculated based on the Logarithm of the Minimum Angle of Resolution (logMAR score). Any maximum worst-case change from baseline categories are presented for right and left eyes. No change/improved vision is defined as a change from baseline \<0.12; a possible worsened vision is defined as a change from baseline \>=0.12 to \<0.3; a definite worsened vision is defined as a change from baseline \>=0.3 logMAR score. Baseline was defined as the most recent, non-missing value prior to or on the first study treatment dose date.
Time frame: Baseline (Day 1) and up to approximately 178 weeks
Part 2 - Time Taken for the Onset of First Occurrence of Worsening in BCVA Score
The time for the onset of any visual acuity event (change from baseline logMAR score \>= 0.3 in either eye) was calculated.
Time frame: Up to approximately 178 weeks
Part 2 - Outcome of First Occurrence of Worsening Eye in BCVA Score
The onset of any visual acuity event (change from baseline in logMAR score \>= 0.3 in either eye) was considered resolved if the change from baseline in logMAR score was less than 0.3 in both eyes. Participants with resolved and not resolved outcome of the worsening eye were presented.
Time frame: Up to approximately 178 weeks
Part 2 - Duration of First Occurrence of Worsening in BCVA Score
The time from onset of any visual acuity event (change from baseline logMAR score \>= 0.3 in either eye) until the event is resolved (change from baseline logMAR score \< 0.3 in both eyes) was used to calculate the duration of first occurrence.
Time frame: Up to approximately 178 weeks
Part 2 - Number of Participants According to the Number of Definite Events of Worsening of Vision
A definite worsened vision was defined as a change from baseline \>=0.3 logMAR score.
Time frame: Up to approximately 178 weeks
Part 2 - Number of Participants With Resolution of Post Treatment Exposure Worsening in BCVA Score
The event was considered resolved if the change from baseline in logMAR score \< 0.3 in both eyes.
Time frame: Up to approximately 178 weeks
Part 2 - Duration of Resolution Post-treatment Exposure of Worsening in BCVA Score
The time taken for the resolution of worsening eye post treatment exposure. Duration was defined as the time from onset of any visual acuity event (change from baseline logMAR score \>= 0.3 in either eye) until the event was considered resolved (change from baseline logMAR score \< 0.3 in both eyes). It required at least a one day gap between the resolution of all events from first occurrence to the onset of second occurrence. The end of treatment exposure was defined as 20 days from last infusion date.
Time frame: Up to approximately 178 weeks
Part 2 - Number of Participants With Post-baseline Decline in BCVA to Light Perception or no Light Perception
Time frame: Baseline (Day 1) and up to approximately 178 weeks
Part 2 - Number of Participants With Worst-case Shift From Baseline in Ophthalmological Epithelium Exam
Participants with worst-case shift from baseline in corneal epithelium defects by right eye, left eye and worse eye are presented as normal (N), abnormal (AN) and missing. Baseline was defined as the most recent, non-missing value prior to or on the first study treatment dose date.
Time frame: Baseline (Day 1) and up to approximately 178 weeks
Part 2 - Number of Participants With Worst-case Shift From Baseline in Corneal Examinations
Participants with worst-case shift from baseline in corneal examination: corneal ulcer, epithelial microcystic edema, subepithelial haze, corneal neovascularization and microcysts without edema, by right eye (R), left eye (L) and worse eye (W) are presented as yes (Y), no (N) and missing (M). Baseline was defined as the most recent, non-missing value prior to or on the first study treatment dose date.
Time frame: Baseline (Day 1) and up to approximately 178 weeks
Part 2 - Number of Participants With Worse Case Post-baseline Punctate Keratopathy Findings
Participants with worse case punctate keratopathy findings post baseline at any ocular exam by right eye, left eye and worse eye are presented as none, mild, moderate and severe. Worse eye indicates the eye with the worst visual acuity. Baseline was defined as the most recent, non-missing value prior to or on the first study treatment dose date.
Time frame: Baseline (Day 1) and up to approximately 178 weeks
Part 2 - Number of Participants With Worst-case Shift From Baseline in Lens Examinations
Participants with worst-case shift from baseline in corneal examination which included: clear, pseudophakia, nuclear sclerosis, cortical cataract and posterior subcapsular cataract by right eye, left eye and worse eye are presented as yes (Y), no (N) and missing. Baseline was defined as the most recent, non-missing value prior to or on the first study treatment dose date.
Time frame: Baseline (Day 1) and up to approximately 178 weeks
Part 2 - Percentage of Participants With Clinical Benefit Rate
Clinical benefit rate was defined as the percentage of participants with a confirmed minimal response (MR) or better according to the IMWG Response Criteria. MR is \>= 25% but \< 49% reduction of serum M-protein and reduction in 24-hour urinary M-protein by 50-89%.
Time frame: Up to approximately 178 weeks
Part 2 - Duration of Response
Duration of response was defined as the time from first documented evidence of PR or better, to the time when disease progression (PD) is documented per IMWG response criteria; or death due to PD occurs among participants who achieve an overall response, i.e. confirmed PR or better. PD= Increase of 25% from lowest confirmed response value in 1 or more of the following criteria: Serum M-protein with absolute increase of \>= 0.5 g/dL; Serum M-protein increase \>= 1 g/dL if the lowest M-component was \>=5 g/dL; Urinary M-protein (absolute increase must be \>= 200 mg per 24 h). PR = ≥50% reduction of serum M-protein and reduction in 24-hour urinary M-protein by ≥ 90% or to \<200 mg/24 h.
Time frame: Up to approximately 178 weeks
Part 2 - Time to Response
Time to response (TTR) was defined as the time between the date of first dose and the first documented evidence of response (PR or better) among participants who achieved a confirmed response of PR or better.
Time frame: Up to approximately 178 weeks
Part 2 - Time to Best Response
Time to best response was defined as the time between the date of first dose and the first best documented response (PR or better) among participants who achieved a confirmed response of PR or better.
Time frame: Up to approximately 178 weeks
Part 2 - Progression-free Survival
Progression-free survival was defined as the time from first dose until the earliest date of PD per IMWG response criteria, or death due to any cause. PD= Increase of 25% from lowest confirmed response value in 1 or more of the following criteria: Serum M-protein with absolute increase of \>= 0.5 g/dL; Serum M-protein increase \>= 1 g/dL if the lowest M-component was \>=5 g/dL; Urinary M-protein (absolute increase must be \>= 200 mg per 24 h).
Time frame: Up to approximately 178 weeks
Part 2 - Time to Disease Progression
Time to disease progression was defined as the time from first dose until the earliest date of PD per IMWG response criteria, or death due to PD. PD= Increase of 25% from lowest confirmed response value in 1 or more of the following criteria: Serum M-protein with absolute increase of \>= 0.5 g/dL; Serum M-protein increase \>= 1 g/dL if the lowest M-component was \>=5 g/dL; Urinary M-protein (absolute increase must be \>= 200 mg per 24 h).
Time frame: Up to approximately 178 weeks
Part 2 - Overall Survival
Overall Survival was defined as the time from first dose until death due to any cause.
Time frame: Up to approximately 178 weeks
Part 1 - Maximum Concentration (Cmax) for Belantamab Mafodotin After First Dose
Blood samples were collected for Pharmacokinetic (PK) analysis of belantamab mafodotin when administered intravenously in combination with pembrolizumab. PK parameter was determined using standard non-compartmental methods.
Time frame: Pre-dose, end of infusion (EOI), 2, 4, 9, and 24 h post-SOI (start of infusion) on Cycle 1 Day 1, Cycle 1 Day 4, Cycle 1 Day 8, and pre-dose on Cycle 2 Day 1
Part 2 - Cmax for Belantamab Mafodotin After First Dose
Blood samples were collected for PK analysis of belantamab mafodotin when administered intravenously in combination with pembrolizumab. PK parameter was determined using standard non-compartmental methods.
Time frame: Pre-dose, EOI, 2, 4, 9, and 24 h post-SOI on Cycle 1 Day 1, Cycle 1 Day 4, Cycle 1 Day 8, and pre-dose on Cycle 2 Day 1
Part 1 - End of Infusion Concentration (C-EOI) for Belantamab Mafodotin
Blood samples were collected for PK analysis of belantamab mafodotin when administered intravenously in combination with pembrolizumab. PK parameter was determined using standard non-compartmental methods.
Time frame: EOI post belantamab mafodotin dose on Day 1 of each 21 day Cycle till Cycle 11
Part 2 - C-EOI for Belantamab Mafodotin
Blood samples were collected for PK analysis of belantamab mafodotin when administered intravenously in combination with pembrolizumab. PK parameter was determined using standard non-compartmental methods.
Time frame: EOI post belantamab mafodotin dose on Day 1 of each 21 day Cycle till Cycle 11
Part 1 - Time of Cmax (Tmax) for Belantamab Mafodotin After First Dose
Blood samples were collected for PK analysis of belantamab mafodotin when administered intravenously in combination with pembrolizumab. PK parameter was determined using standard non-compartmental methods.
Time frame: Pre-dose, EOI, 2, 4, 9, and 24 h post-SOI on Cycle 1 Day 1, Cycle 1 Day 4, Cycle 1 Day 8, and pre-dose on Cycle 2 Day 1
Part 2 - Tmax for Belantamab Mafodotin After First Dose
Blood samples were collected for PK analysis of belantamab mafodotin when administered intravenously in combination with pembrolizumab. PK parameter was determined using standard non-compartmental methods.
Time frame: Pre-dose, EOI, 2, 4, 9, and 24 h post-SOI on Cycle 1 Day 1, Cycle 1 Day 4, Cycle 1 Day 8, and pre-dose on Cycle 2 Day 1
Part 1 - Trough Concentration Prior to the Next Dose for Each Cycle (Ctrough) for Belantamab Mafodotin
Blood samples were collected for PK analysis of belantamab mafodotin when administered intravenously in combination with pembrolizumab. Ctrough was calculated as the observed concentration at the end of a dosing interval, immediately before next study drug administration on Day 1 of each Cycle. PK parameter was determined using standard non-compartmental methods.
Time frame: Pre-dose on Day 1 of each 21 day cycle from Cycle 1 until Cycle 13
Part 2 - Ctrough for Belantamab Mafodotin
Blood samples were collected for PK analysis of belantamab mafodotin when administered intravenously in combination with pembrolizumab. Ctrough was calculated as the observed concentration at the end of a dosing interval, immediately before next study drug administration on Day 1 of each Cycle. PK parameter was determined using standard non-compartmental methods.
Time frame: Pre-dose on Day 1 of each 21 day cycle from Cycle 1 until Cycle 13
Part 1 - Last Time Point Where the Concentration is Above the Limit of Quantification (Tlast) for Belantamab Mafodotin After First Dose
Blood samples were collected for PK analysis of belantamab mafodotin when administered intravenously in combination with pembrolizumab. PK parameter was determined using standard non-compartmental methods.
Time frame: Pre-dose, EOI, 2, 4, 9, and 24 h post-SOI on Cycle 1 Day 1, Cycle 1 Day 4, Cycle 1 Day 8, and pre-dose on Cycle 2 Day 1
Part 2 - Tlast for Belantamab Mafodotin After First Dose
Blood samples were collected for PK analysis of belantamab mafodotin when administered intravenously in combination with pembrolizumab. PK parameter was determined using standard non-compartmental methods.
Time frame: Pre-dose, EOI, 2, 4, 9, and 24 h post-SOI on Cycle 1 Day 1, Cycle 1 Day 4, Cycle 1 Day 8, and pre-dose on Cycle 2 Day 1
Part 1 - Area Under Plasma Concentration-time Curve (AUC) From Time 0 to End of the Dosing Interval [AUC (0-tau)] for Belantamab Mafodotin After First Dose
Blood samples were collected for PK analysis of belantamab mafodotin when administered intravenously in combination with pembrolizumab. PK parameter was determined using standard non-compartmental methods.
Time frame: Pre-dose, EOI, 2, 4, 9, and 24 h post-SOI on Cycle 1 Day 1, Cycle 1 Day 4, Cycle 1 Day 8, and pre-dose on Cycle 2 Day 1
Part 2 - AUC (0-tau) for Belantamab Mafodotin After First Dose
Blood samples were collected for PK analysis of belantamab mafodotin when administered intravenously in combination with pembrolizumab. PK parameter was determined using standard non-compartmental methods.
Time frame: Pre-dose, EOI, 2, 4, 9, and 24 h post-SOI on Cycle 1 Day 1, Cycle 1 Day 4, Cycle 1 Day 8, and pre-dose on Cycle 2 Day 1
Part 1 - Cmax for Total Monoclonal Antibody (mAb) After First Dose
Blood samples were collected for PK analysis of belantamab mafodotin when administered intravenously in combination with pembrolizumab. PK parameter was determined using standard non-compartmental methods.
Time frame: Pre-dose, EOI, 2, 4, 9, and 24 hour post-SOI on Cycle 1 Day 1, Cycle 1 Day 4, Cycle 1 Day 8, and pre-dose on Cycle 2 Day 1
Part 2 - Cmax for Total mAb After First Dose
Blood samples were collected for PK analysis of belantamab mafodotin when administered intravenously in combination with pembrolizumab. PK parameter was determined using standard non-compartmental methods.
Time frame: Pre-dose, EOI, 2, 4, and 24 hour post-SOI on Cycle 1 Day 1, Cycle 1 Day 4, Cycle 1 Day 8, and pre-dose on Cycle 2 Day 1
Part 1 - C-EOI for Total mAb
Blood samples were collected for PK analysis of belantamab mafodotin when administered intravenously in combination with pembrolizumab. PK parameter was determined using standard non-compartmental methods.
Time frame: EOI post belantamab mafodotin dose on Day 1 of Cycle 1, Cycle 2, Cycle 5, Cycle 8, and Cycle 11
Part 2 - C-EOI for Total mAb
Blood samples were collected for PK analysis of belantamab mafodotin when administered intravenously in combination with pembrolizumab. PK parameter was determined using standard non-compartmental methods.
Time frame: EOI post belantamab mafodotin dose on Day 1 of Cycle 1, Cycle 2, and Cycle 5
Part 1 - Tmax for Total mAb After First Dose
Blood samples were collected for PK analysis of belantamab mafodotin when administered intravenously in combination with pembrolizumab. PK parameter was determined using standard non-compartmental methods.
Time frame: Pre-dose, EOI, 2, 4, 9, and 24 hour post-SOI on Cycle 1 Day 1, Cycle 1 Day 4, Cycle 1 Day 8, and pre-dose on Cycle 2 Day 1
Part 2 - Tmax for Total mAb After First Dose
Blood samples were collected for PK analysis of belantamab mafodotin when administered intravenously in combination with pembrolizumab. PK parameter was determined using standard non-compartmental methods.
Time frame: Pre-dose, EOI, 2, 4, and 24 hour post-SOI on Cycle 1 Day 1, Cycle 1 Day 4, Cycle 1 Day 8, and pre-dose on Cycle 2 Day 1
Part 1 - Ctrough for Total mAb
Blood samples were collected for PK analysis of belantamab mafodotin when administered intravenously in combination with pembrolizumab. Ctrough was calculated as the observed concentration at the end of a dosing interval, immediately before next study drug administration on Day 1 of each Cycle. PK parameter was determined using standard non-compartmental methods.
Time frame: Cycle 1, Cycle 4, Cycle 7, Cycle 10, and Cycle 13
Part 2 - Ctrough for Total mAb
Blood samples were collected for PK analysis of belantamab mafodotin when administered intravenously in combination with pembrolizumab. Ctrough was calculated as the observed concentration at the end of a dosing interval, immediately before next study drug administration on Day 1 of each Cycle. PK parameter was determined using standard non-compartmental methods.
Time frame: Cycle 1 and Cycle 4
Part 1 - Last Time Point Where the Concentration is Above the Limit of Quantification (Tlast) for Total mAb After First Dose
Blood samples were collected for PK analysis of belantamab mafodotin when administered intravenously in combination with pembrolizumab. PK parameter was determined using standard non-compartmental methods. Tlast is the time of last observed quantifiable concentration of belantamab mafodotin in Cycle 1 which extended beyond protocol defined duration for some participants across treatment groups.
Time frame: Pre-dose, EOI, 2, 4, 9, and 24 hour post-SOI on Cycle 1 Day 1, Cycle 1 Day 4, Cycle 1 Day 8, and pre-dose on Cycle 2 Day 1
Part 2 - Tlast for Total mAb After First Dose
Blood samples were collected for PK analysis of belantamab mafodotin when administered intravenously in combination with pembrolizumab. PK parameter was determined using standard non-compartmental methods. Tlast is the time of last observed quantifiable concentration of belantamab mafodotin in Cycle 1 which extended beyond protocol defined duration for some participants across treatment groups.
Time frame: Pre-dose, EOI, 2, 4, and 24 hour post-SOI on Cycle 1 Day 1, Cycle 1 Day 4, Cycle 1 Day 8, and pre-dose on Cycle 2 Day 1
Part 1 - AUC (0-tau) for Total mAb After First Dose
Blood samples were collected for PK analysis of belantamab mafodotin when administered intravenously in combination with pembrolizumab. PK parameter was determined using standard non-compartmental methods.
Time frame: Pre-dose, EOI, 2, 4, 9, and 24 hour post-SOI on Cycle 1 Day 1, Cycle 1 Day 4, Cycle 1 Day 8, and pre-dose on Cycle 2 Day 1
Part 2 - AUC (0-tau) for Total mAb After First Dose
Blood samples were collected for PK analysis of belantamab mafodotin when administered intravenously in combination with pembrolizumab. PK parameter was determined using standard non-compartmental methods.
Time frame: Pre-dose, EOI, 2, 4, and 24 hour post-SOI on Cycle 1 Day 1, Cycle 1 Day 4, Cycle 1 Day 8, and pre-dose on Cycle 2 Day 1
Part 1 - Cmax for Cysteine Maleimidocaproyl Monomethyl Auristatin F (Cys-mcMMAF) After First Dose
Blood samples were collected for PK analysis of belantamab mafodotin when administered intravenously in combination with pembrolizumab. PK parameter was determined using standard non-compartmental methods.
Time frame: Pre-dose, EOI, 2, 4, 9, and 24 hour post-SOI on Cycle 1 Day 1, Cycle 1 Day 4, Cycle 1 Day 8, and pre-dose on Cycle 2 Day 1
Part 2 - Cmax for Cys-mcMMAF After First Dose
Blood samples were collected for PK analysis of belantamab mafodotin when administered intravenously in combination with pembrolizumab. PK parameter was determined using standard non-compartmental methods.
Time frame: Pre-dose, EOI, 2, 4, and 24 hour post-SOI on Cycle 1 Day 1, Cycle 1 Day 4, Cycle 1 Day 8, and pre-dose on Cycle 2 Day 1
Part 1 - C-EOI for Cys-mcMMAF After First Dose
Blood samples were collected for PK analysis of belantamab mafodotin when administered intravenously in combination with pembrolizumab. PK parameter was determined using standard non-compartmental methods.
Time frame: EOI post belantamab mafodotin dose on Day 1 of Cycle 1
Part 2 - C-EOI for Cys-mcMMAF After First Dose
Blood samples were collected for PK analysis of belantamab mafodotin when administered intravenously in combination with pembrolizumab. PK parameter was determined using standard non-compartmental methods.
Time frame: EOI post belantamab mafodotin dose on Day 1 of Cycle 1
Part 1 - Tmax for Cys-mcMMAF After First Dose
Blood samples were collected for PK analysis of belantamab mafodotin when administered intravenously in combination with pembrolizumab. PK parameter was determined using standard non-compartmental methods. Tlast is the time of last observed quantifiable concentration of belantamab mafodotin in Cycle 1 which extended beyond protocol defined duration for some participants across treatment groups.
Time frame: Pre-dose, EOI, 2, 4, 9, and 24 hour post-SOI on Cycle 1 Day 1, Cycle 1 Day 4, Cycle 1 Day 8, and pre-dose on Cycle 2 Day 1
Part 2 - Tmax for Cys-mcMMAF After First Dose
Blood samples were collected for PK analysis of belantamab mafodotin when administered intravenously in combination with pembrolizumab. PK parameter was determined using standard non-compartmental methods. Tlast is the time of last observed quantifiable concentration of belantamab mafodotin in Cycle 1 which extended beyond protocol defined duration for some participants across treatment groups.
Time frame: Pre-dose, EOI, 2, 4, and 24 hour post-SOI on Cycle 1 Day 1, Cycle 1 Day 4, Cycle 1 Day 8, and pre-dose on Cycle 2 Day 1
Part 1 - Tlast for Cys-mcMMAF After First Dose
Blood samples were collected for PK analysis of belantamab mafodotin when administered intravenously in combination with pembrolizumab. PK parameter was determined using standard non-compartmental methods. Tlast is the time of last observed quantifiable concentration of belantamab mafodotin in Cycle 1 which extended beyond protocol defined duration for some participants across treatment groups.
Time frame: Pre-dose, EOI, 2, 4, 9, and 24 hour post-SOI on Cycle 1 Day 1, Cycle 1 Day 4, Cycle 1 Day 8, and pre-dose on Cycle 2 Day 1
Part 2 - Tlast for Cys-mcMMAF After First Dose
Blood samples were collected for PK analysis of belantamab mafodotin when administered intravenously in combination with pembrolizumab. PK parameter was determined using standard non-compartmental methods. Tlast is the time of last observed quantifiable concentration of belantamab mafodotin in Cycle 1 which extended beyond protocol defined duration for some participants across treatment groups.
Time frame: Pre-dose, EOI, 2, 4, and 24 hour post-SOI on Cycle 1 Day 1, Cycle 1 Day 4, Cycle 1 Day 8, and pre-dose on Cycle 2 Day 1
Part 1 - AUC From Time 0 to 168 h After Dosing [AUC (0-168h)] for Cys-mcMMAF After First Dose
Blood samples were collected for PK analysis of belantamab mafodotin when administered intravenously in combination with pembrolizumab. PK parameter was determined using standard non-compartmental methods.
Time frame: Pre-dose, EOI, 2, 4, 9, and 24 hour post-SOI on Cycle 1 Day 1, Cycle 1 Day 4, and Cycle 1 Day 8
Part 2 - AUC (0-168 h) for Cys-mcMMAF After First Dose
Blood samples were collected for PK analysis of belantamab mafodotin when administered intravenously in combination with pembrolizumab. PK parameter was determined using standard non-compartmental methods.
Time frame: Pre-dose, EOI, 2, 4, and 24 hour post-SOI on Cycle 1 Day 1, Cycle 1 Day 4, and Cycle 1 Day 8
Part 1 - Cmax for Pembrolizumab After First Dose
Blood samples were collected for PK analysis of belantamab mafodotin when administered intravenously in combination with pembrolizumab. PK parameter was determined using standard non-compartmental methods.
Time frame: Pre-dose, EOI, 2, 4, 9, and 24 h post-SOI on Cycle 1 Day 1, Cycle 1 Day 4, Cycle 1 Day 8, and pre-dose on Cycle 2 Day 1
Part 2 - Cmax for Pembrolizumab After First Dose
Blood samples were collected for PK analysis of belantamab mafodotin when administered intravenously in combination with pembrolizumab. PK parameter was determined using standard non-compartmental methods.
Time frame: Pre-dose, EOI, 2, 4, 9, and 24 h post-SOI on Cycle 1 Day 1, Cycle 1 Day 4, Cycle 1 Day 8, and pre-dose on Cycle 2 Day 1
Part 1 - Tmax for Pembrolizumab After First Dose
Blood samples were collected for PK analysis of belantamab mafodotin when administered intravenously in combination with pembrolizumab. PK parameter was determined using standard non-compartmental methods.
Time frame: Pre-dose, EOI, 2, 4, 9, and 24 h post-SOI on Cycle 1 Day 1, Cycle 1 Day 4, Cycle 1 Day 8, and pre-dose on Cycle 2 Day 1
Part 2 - Tmax for Pembrolizumab After First Dose
Blood samples were collected for PK analysis of belantamab mafodotin when administered intravenously in combination with pembrolizumab. PK parameter was determined using standard non-compartmental methods.
Time frame: Pre-dose, EOI, 2, 4, 9, and 24 h post-SOI on Cycle 1 Day 1, Cycle 1 Day 4, Cycle 1 Day 8, and pre-dose on Cycle 2 Day 1
Part 1 - AUC (0-tau) for Pembrolizumab After First Dose
Blood samples were collected for PK analysis of belantamab mafodotin when administered intravenously in combination with pembrolizumab. PK parameter was determined using standard non-compartmental methods.
Time frame: Pre-dose, EOI, 2, 4, 9, and 24 h post-SOI on Cycle 1 Day 1, Cycle 1 Day 4, Cycle 1 Day 8, and pre-dose on Cycle 2 Day 1
Part 2 - AUC (0-tau) for Pembrolizumab After First Dose
Blood samples were collected for PK analysis of belantamab mafodotin when administered intravenously in combination with pembrolizumab. PK parameter was determined using standard non-compartmental methods.
Time frame: Pre-dose, EOI, 2, 4, 9, and 24 h post-SOI on Cycle 1 Day 1, Cycle 1 Day 4, Cycle 1 Day 8, and pre-dose on Cycle 2 Day 1
Part 1 - Number of Participants With Post-baseline Positive Anti-drug Antibodies (ADAs) Against Belantamab Mafodotin
Serum samples collected for the analysis of the presence of ADAs using validated immunoassays. All samples were tested in screening assay, and positive samples were further characterized for antibody titers. At the time of primary results posting, there was no participants with positive ADA results. Baseline was defined as the most recent, non-missing value prior to or on the first study treatment dose date.
Time frame: Baseline (Day 1) and until end of treatment (up to 178 weeks)
Part 2 - Number of Participants With Post-baseline Positive ADAs Against Belantamab Mafodotin
Serum samples collected for the analysis of the presence of ADAs using validated immunoassays. All samples were tested in screening assay, and positive samples were further characterized for antibody titers. At the time of primary results posting, there was no participants with positive ADA results. Baseline was defined as the most recent, non-missing value prior to or on the first study treatment dose date.
Time frame: Baseline (Day 1) and until end of treatment (up to 178 weeks)
Part 1 - Titers of ADAs Against Belantamab Mafodotin
Serum samples collected for the analysis of the presence of ADAs using validated immunoassays. All samples were to be further tested in screening assay, and positive samples were further to be characterized for antibody titers.
Time frame: Up to approximately 178 weeks
Part 2 - Titers of ADAs Against Belantamab Mafodotin
Serum samples collected for the analysis of the presence of ADAs using validated immunoassays. All samples were to be further tested in screening assay, and positive samples were further to be characterized for antibody titers.
Time frame: Baseline (Day 1) and up to approximately 178 weeks

Results

Posted Dec 23, 2022

Participant flow

The study consisted of two phases - Main Study Phase and Post Analysis Continued Treatment (PACT) Phase. In PACT phase those participants still benefiting from drug continued to receive study drug until discontinued or withdrawn from study.

Main Study Phase (Day 1 to Week 178)

Participant flow — Main Study Phase (Day 1 to Week 178)
Milestone	Main Study Phase- Part 1: Belantamab Mafodotin 2.5 mg/kg + Pembrolizumab 200 mg Escalation	Main Study Phase- Part 1: Belantamab Mafodotin 3.4 mg/kg + Pembrolizumab 200 mg Escalation	Main Study Phase- Part 2: Belantamab Mafodotin 2.5 mg/kg + Pembrolizumab 200 mg Expansion
Started	6	7	28
Completed	3	4	19
Not completed	3	3	9
Withdrew: Lost to follow-up	0	1	0
Withdrew: Physician decision	0	0	1
Withdrew: Withdrawal by subject	3	2	8

PACT Phase (Week 178 to Week 221)

Participant flow — PACT Phase (Week 178 to Week 221)
Milestone	Main Study Phase- Part 1: Belantamab Mafodotin 2.5 mg/kg + Pembrolizumab 200 mg Escalation	Main Study Phase- Part 1: Belantamab Mafodotin 3.4 mg/kg + Pembrolizumab 200 mg Escalation	Main Study Phase- Part 2: Belantamab Mafodotin 2.5 mg/kg + Pembrolizumab 200 mg Expansion	PACT Phase- Belantamab Mafodotin 2.5 mg/kg + Pembrolizumab 200 mg
Started	0	0	0	2
Completed	0	0	0	1
Not completed	0	0	0	1
Withdrew: Withdrawal by subject	0	0	0	1

Outcome measures

PrimaryPart 1 - Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)

An AE is any untoward medical occurrence in a clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. SAE is defined as any untoward medical occurrence that, at any dose results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect, other situations which involve medical or scientific judgment or is associated with liver injury and impaired liver function.

Time frame:: Up to approximately 31 months
Reported as:: Count of participants · Participants

Part 1 - Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
Participants	Main Study Phase- Part 1: Belantamab Mafodotin 2.5 mg/kg + Pembrolizumab 200 mg Escalation	Main Study Phase- Part 1: Belantamab Mafodotin 3.4 mg/kg + Pembrolizumab 200 mg Escalation
AEs	6	7
SAEs	4	5

PrimaryPart 1 - Number of Participants With Dose Limiting Toxicities (DLTs)

DLT is an AE that is considered by the investigator to be clinically relevant and attributed to the study therapy during the 21 day DLT period and meets at least one of the DLT criteria: any Grade 4 and 3 non-hematologic toxicity, any Grade 3 or greater non-hematologic laboratory value, hematologic toxicity lasting \>=7 days, except Grade 4 thrombocytopenia of any duration or Grade 3 thrombocytopenia associated with clinically significant bleeding. Grade 3 or greater febrile neutropenia lasting \>48 hours (h) despite adequate treatment, Nephrotoxicity requiring dialysis, Liver toxicity, prolonged delay (\>14 days) in initiating Cycle 2 due to any treatment (pembrolizumab or GSK2857916) related toxicity, any treatment-related toxicity that causes discontinuation of treatment during Cycle 1, any other toxicity considered to be dose-limiting that occurs beyond 21 days and any other event which in the judgment of the investigator and GlaxoSmithKline Medical Monitor is considered to be a DLT.

Time frame:: Up to 21 days
Reported as:: Count of participants · Participants

Part 1 - Number of Participants With Dose Limiting Toxicities (DLTs)
Participants	Main Study Phase- Part 1: Belantamab Mafodotin 2.5 mg/kg + Pembrolizumab 200 mg Escalation	Main Study Phase- Part 1: Belantamab Mafodotin 3.4 mg/kg + Pembrolizumab 200 mg Escalation
Part 1 - Number of Participants With Dose Limiting Toxicities (DLTs)	0	0

PrimaryPart 1 - Number of Participants With Worst-case Grade Change From Baseline in Hematology Parameters

Blood samples were collected for the analysis of following hematology parameters: hemoglobin, White blood cells (WBC) count, lymphocytes, neutrophils and platelet count. The laboratory parameters were graded according to National Cancer Institute-Common Terminology Criteria for Adverse Events (NCI-CTCAE) version 4.03. Grade 1: mild; Grade 2: moderate; Grade 3: severe or medically significant; Grade 4: life-threatening consequences. Higher grade indicates greater severity and an increase in CTCAE grade was defined relative to the Baseline grade. Baseline was defined as the most recent, non-missing value prior to or on the first study treatment dose date. Any worst-case post baseline increase in grade along with any increase to a maximum grade of 3 and a maximum grade of 4 are presented.

Time frame:: Baseline (Day 1) and up to approximately 31 months
Reported as:: Count of participants · Participants

Part 1 - Number of Participants With Worst-case Grade Change From Baseline in Hematology Parameters
Participants	Main Study Phase- Part 1: Belantamab Mafodotin 2.5 mg/kg + Pembrolizumab 200 mg Escalation	Main Study Phase- Part 1: Belantamab Mafodotin 3.4 mg/kg + Pembrolizumab 200 mg Escalation
Hemoglobin Decreased (Anemia), Any Grade Increase	4	2
Hemoglobin Decreased (Anemia), Increase to Grade 3	3	1
Hemoglobin Decreased (Anemia), Increase to Grade 4	0	0
Hemoglobin Increased, Any Grade Increase	0	0
Hemoglobin Increased, Increase to Grade 3	0	0
Hemoglobin Increased, Increase to Grade 4	0	0
WBC Increased (Leukocytosis), Any Grade Increase	0	0
WBC Increased (Leukocytosis), Increase to Grade 3	0	0
WBC Increased (Leukocytosis), Increase to Grade 4	0	0
WBC Decreased, Any Grade Increase	3	3
WBC Decreased, Increase to Grade 3	1	1
WBC Decreased, Increase to Grade 4	0	0
Lymphocyte Decreased, Any Grade Increase	4	1
Lymphocyte Decreased, Increase to Grade 3	1	1
Lymphocyte Decreased, Increase to Grade 4	1	0
Lymphocyte Increased, Any Grade Increase	0	1
Lymphocyte Increased, Increase to Grade 3	0	0
Lymphocyte Increased, Increase to Grade 4	0	0
Neutrophil Decreased, Any Grade Increase	5	2
Neutrophil Decreased, Increase to Grade 3	2	1
Neutrophil Decreased, Increase to Grade 4	0	1
Platelet Decreased, Any Grade Increase	5	5
Platelet Decreased, Increase to Grade 3	3	3
Platelet Decreased, Increase to Grade 4	1	0

PrimaryPart 1 - Number of Participants With Worst-case Change Post-baseline in Hematology Parameters

Blood samples were collected for the analysis of following hematology parameters: basophils, eosinophils, mean corpuscular hemoglobin concentration (MCHC), mean corpuscular hemoglobin (MCH), mean corpuscular volume (MCV), erythrocytes, hematocrit, monocytes, neutrophils and reticulocyte. The summaries of worst-case change from baseline with respect to normal range was analyzed for only those laboratory tests that were not gradable by CTCAE version 4.03. The number of participants with decreases to low from baseline, changes to normal or no changes from baseline, and increases to high values have been presented.

Time frame:: Baseline (Day 1) and up to approximately 31 months
Reported as:: Count of participants · Participants

Part 1 - Number of Participants With Worst-case Change Post-baseline in Hematology Parameters
Participants	Main Study Phase- Part 1: Belantamab Mafodotin 2.5 mg/kg + Pembrolizumab 200 mg Escalation	Main Study Phase- Part 1: Belantamab Mafodotin 3.4 mg/kg + Pembrolizumab 200 mg Escalation
Basophils, Decrease to Low	0	0
Basophils, Change to Normal or No Change	6	6
Basophils, Increase to High	0	0
Eosinophils, Decrease to Low	2	1
Eosinophils, Change to Normal or No Change	4	6
Eosinophils, Increase to High	0	0
MCHC, Decrease to Low	0	1
MCHC, Change to Normal or No Change	6	4
MCHC, Increase to High	0	2
MCH, Decrease to Low	2	0
MCH, Change to Normal or No Change	3	5
MCH, Increase to High	0	1
MCV, Decrease to Low	1	0
MCV, Change to Normal or No Change	5	6
MCV, Increase to High	0	1
Erythrocytes, Decrease to Low	0	1
Erythrocytes, Change to Normal or No Change	6	6
Erythrocytes, Increase to High	0	0
Hematocrit, Decrease to Low	0	0
Hematocrit, Change to Normal or No Change	5	7
Hematocrit, Increase to High	1	0
Monocytes, Decrease to Low	0	0
Monocytes, Change to Normal or No Change	3	4
Monocytes, Increase to High	3	3
Reticulocyte, Decrease to Low	4	0
Reticulocyte, Change to Normal or No Change	0	4
Reticulocyte, Increase to High	4	2

PrimaryPart 1 - Number of Participants With Worst-case Grade Change From Baseline in Lab Chemistry Parameters

Blood samples were collected for the analysis of clinical chemistry parameters: glucose, alanine aminotransferase (ALT), albumin, alkaline phosphatase, aspartate aminotransferase (AST), blood bilirubin, calcium, creatine kinase (CPK), creatinine, gamma glutamyl transferase (GGT), magnesium, phosphate, potassium and sodium. Laboratory parameters were graded according to NCI-CTCAE version 4.03. Grade 1: mild; Grade 2: moderate; Grade 3: severe or medically significant; Grade 4: life-threatening consequences. Higher grade indicates greater severity and an increase in CTCAE grade was defined relative to the Baseline grade. Baseline was defined as the most recent, non-missing value prior to or on the first study treatment dose date. Any worst case post baseline increase in grade along with any increase to a maximum grade of 3 and a maximum grade of 4 are presented.

Time frame:: Baseline (Day 1) and up to approximately 31 months
Reported as:: Count of participants · Participants

Part 1 - Number of Participants With Worst-case Grade Change From Baseline in Lab Chemistry Parameters
Participants	Main Study Phase- Part 1: Belantamab Mafodotin 2.5 mg/kg + Pembrolizumab 200 mg Escalation	Main Study Phase- Part 1: Belantamab Mafodotin 3.4 mg/kg + Pembrolizumab 200 mg Escalation
Glucose Increased (Hyperglycemia), Any Grade Increase	0	0
Glucose Increased (Hyperglycemia), Increase to Grade 3	0	0
Glucose Increased (Hyperglycemia), Increase to Grade 4	0	0
Glucose Decreased (Hypoglycemia), Any Grade Increase	1	0
Glucose Decreased (Hypoglycemia), Increase to Grade 3	0	0
Glucose Decreased (Hypoglycemia), Increase to Grade 4	0	0
ALT Increased, Any Grade Increase	3	0
ALT Increased, Increase to Grade 3	0	0
ALT Increased, Increase to Grade 4	0	0
Albumin Decreased (Hypoalbuminemia), Any Grade Increase	1	4
Albumin Decreased (Hypoalbuminemia), Increase to Grade 3	0	0
Albumin Decreased (Hypoalbuminemia), Increase to Grade 4	0	0
Alkaline phosphatase Increased, Any Grade Increase	3	2
Alkaline phosphatase Increased, Increase to Grade 3	0	0
Alkaline phosphatase Increased, Increase to Grade 4	0	0
AST Increased, Any Grade Increase	5	5
AST Increased, Increase to Grade 3	0	0
AST Increased, Increase to Grade 4	0	0
Blood bilirubin Increased, Any Grade Increase	0	1
Blood bilirubin Increased, Increase to Grade 3	0	0
Blood bilirubin Increased, Increase to Grade 4	0	0
Calcium Increased (Hypercalcemia), Any Grade Increase	2	1
Calcium Increased (Hypercalcemia), Increase to Grade 3	0	0
Calcium Increased (Hypercalcemia), Increase to Grade 4	0	0
Calcium Decreased (Hypocalcemia), Any Grade Increase	2	0
Calcium Decreased (Hypocalcemia), Increase to Grade 3	0	0
Calcium Decreased (Hypocalcemia), Increase to Grade 4	0	0
CPK Increased, Any Grade Increase	1	2
CPK Increased, Increase to Grade 3	0	0
CPK Increased, Increase to Grade 4	0	0
Creatinine Increased, Any Grade Increase	2	1
Creatinine Increased, Increase to Grade 3	0	0
Creatinine Increased, Increase to Grade 4	0	0
GGT Increased, Any Grade Increase	3	2
GGT Increased, Increase to Grade 3	0	0
GGT Increased, Increase to Grade 4	0	0
Magnesium Increased (Hypermagnesemia), Any Grade Increase	0	0
Magnesium Increased (Hypermagnesemia), Increase to Grade 3	0	0
Magnesium Increased (Hypermagnesemia), Increase to Grade 4	0	0
Magnesium Decreased (Hypomagnesemia), Any Grade Increase	2	2
Magnesium Decreased (Hypomagnesemia), Increase to Grade 3	0	0
Magnesium Decreased (Hypomagnesemia), Increase to Grade 4	0	0
Phosphate Decreased (Hypophosphatemia), Any Grade Increase	2	0
Phosphate Decreased (Hypophosphatemia), Increase to Grade 3	0	0
Phosphate Decreased (Hypophosphatemia), Increase to Grade 4	0	0
Potassium Increased (Hyperkalemia), Any Grade Increase	0	0
Potassium Increased (Hyperkalemia), Increase to Grade 3	0	0
Potassium Increased (Hyperkalemia), Increase to Grade 4	0	0
Potassium Decreased (Hypokalemia), Any Grade Increase	2	2
Potassium Decreased (Hypokalemia), Increase to Grade 3	0	1
Potassium Decreased (Hypokalemia), Increase to Grade 4	0	0
Sodium Increased (Hypernatremia), Any Grade Increase	0	0
Sodium Increased (Hypernatremia), Increase to Grade 3	0	0
Sodium Increased (Hypernatremia), Increase to Grade 4	0	0
Sodium Decreased (Hyponatremia), Any Grade Increase	1	3
Sodium Decreased (Hyponatremia), Increase to Grade 3	0	2
Sodium Decreased (Hyponatremia), Increase to Grade 4	0	0

PrimaryPart 1 - Number of Participants With Worst-case Change Post-baseline in Lab Chemistry Parameters

Blood samples were collected for the analysis of following chemistry parameters: calcium, carbon dioxide, chloride, direct bilirubin, protein, thyrotropin (TSH), thyroxine (T4) and triiodothyronine (T3). The summaries of worst case change from baseline with respect to normal range was analyzed for only those laboratory tests that were not gradable by CTCAE version 4.03. The number of participants with decreases to low from baseline, changes to normal or no changes from baseline, and increases to high values have been presented.

Time frame:: Baseline (Day 1) and up to 31 months
Reported as:: Count of participants · Participants

Part 1 - Number of Participants With Worst-case Change Post-baseline in Lab Chemistry Parameters
Participants	Main Study Phase- Part 1: Belantamab Mafodotin 2.5 mg/kg + Pembrolizumab 200 mg Escalation	Main Study Phase- Part 1: Belantamab Mafodotin 3.4 mg/kg + Pembrolizumab 200 mg Escalation
Calcium, Decrease to Low	1	2
Calcium, Change to Normal or No Change	4	4
Calcium, Increase to High	1	1
Carbon dioxide, Decrease to Low	2	1
Carbon dioxide, Change to Normal or No Change	3	4
Carbon dioxide, Increase to High	1	1
Chloride, Decrease to Low	1	2
Chloride, Change to Normal or No Change	4	4
Chloride, Increase to High	1	1
Direct bilirubin, Decrease to Low	0	0
Direct bilirubin, Change to Normal or No Change	4	5
Direct bilirubin, Increase to High	1	1
Protein, Decrease to Low	2	3
Protein, Change to Normal or No Change	3	4
Protein, Increase to High	1	1
TSH, Decrease to Low	0	0
TSH, Change to Normal or No Change	3	4
TSH, Increase to High	3	2
T4, Decrease to Low	1	0
T4, Change to Normal or No Change	5	6
T4, Increase to High	1	0
T3, Decrease to Low	1	1
T3, Change to Normal or No Change	1	0
T3, Increase to High	0	0

PrimaryPart 1 - Number of Participants With Worst-case Change Post-baseline Urinalysis Results

Urine samples were collected to assess urine glucose, protein, occult blood and ketones using dipstick method. The dipstick test gave results in a semi-quantitative manner, and results for urinalysis parameters were recorded as negative, trace, 1+, 2+, 3+ indicating proportional concentrations in the urine sample. Baseline was defined as the most recent, non-missing value prior to or on the first study treatment dose date. Result for urinalysis parameters were recorded as no change/decreased and any increase. Data for worst-case post baseline urinalysis results is presented.

Time frame:: Baseline (Day 1) and up to approximately 31 months
Reported as:: Count of participants · Participants

Part 1 - Number of Participants With Worst-case Change Post-baseline Urinalysis Results
Participants	Main Study Phase- Part 1: Belantamab Mafodotin 2.5 mg/kg + Pembrolizumab 200 mg Escalation	Main Study Phase- Part 1: Belantamab Mafodotin 3.4 mg/kg + Pembrolizumab 200 mg Escalation
Glucose, No Change/Decreased	6	5
Glucose, Any Increase	0	1
Ketones, No Change/Decreased	3	5
Ketones, Any Increase	3	1
Occult Blood, No Change/Decreased	4	4
Occult Blood, Any Increase	2	1
Protein, No Change/Decreased	4	4
Protein, Any Increase	2	2

PrimaryPart 1 - Changes From Baseline in Urine Potential of Hydrogen (pH)

Urine samples were collected from participants to assess urine pH levels. Baseline was defined as the most recent, non-missing value prior to or on the first study treatment dose date.

Time frame:: Baseline (Day 1) and Week 46
Reported as:: Mean · Potential of Hydrogen (pH)

Part 1 - Changes From Baseline in Urine Potential of Hydrogen (pH)
Potential of Hydrogen (pH)	Main Study Phase- Part 1: Belantamab Mafodotin 2.5 mg/kg + Pembrolizumab 200 mg Escalation	Main Study Phase- Part 1: Belantamab Mafodotin 3.4 mg/kg + Pembrolizumab 200 mg Escalation
Part 1 - Changes From Baseline in Urine Potential of Hydrogen (pH)	1.0 ± 2.83	0.0

PrimaryPart 1 - Changes From Baseline in Urine Specific Gravity

Urine samples were collected from participants to assess urine specific gravity. Baseline was defined as the most recent, non-missing value prior to or on the first study treatment dose date.

Time frame:: Baseline (Day 1) and Week 46
Reported as:: Mean · Ratio

Part 1 - Changes From Baseline in Urine Specific Gravity
Ratio	Main Study Phase- Part 1: Belantamab Mafodotin 2.5 mg/kg + Pembrolizumab 200 mg Escalation	Main Study Phase- Part 1: Belantamab Mafodotin 3.4 mg/kg + Pembrolizumab 200 mg Escalation
Part 1 - Changes From Baseline in Urine Specific Gravity	-0.0010 ± 0.00566	0.0100

PrimaryPart 1 - Number of Participants With Worst-case Grade Change From Baseline in Vital Signs: Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP)

DBP and SBP were measured after resting for at least 5 minutes in a supine or semi-recumbent position. They were graded according to NCI-CTCAE version 4.03. For SBP: Grade 0 (\<=120 millimeter of mercury \[mmHg\]), Grade 1 (121-139 mmHg), Grade 2 (140-159 mmHg), Grade 3 (\>=160 mmHg). For DBP: Grade 0 (\<=80 mmHg), Grade 1 (81-89 mmHg), Grade 2 (90-99 mmHg), Grade 3 (\>=100 mmHg). Higher grade indicates greater severity. Baseline was defined as the most recent, non-missing value prior to or on the first study treatment dose date. Data for worst-case post baseline with any grade increase and a maximum post-baseline grade increase to Grade 3 from their baseline grade are presented.

Time frame:: Baseline (Day 1) and up to approximately 31 months
Reported as:: Count of participants · Participants

Part 1 - Number of Participants With Worst-case Grade Change From Baseline in Vital Signs: Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP)
Participants	Main Study Phase- Part 1: Belantamab Mafodotin 2.5 mg/kg + Pembrolizumab 200 mg Escalation	Main Study Phase- Part 1: Belantamab Mafodotin 3.4 mg/kg + Pembrolizumab 200 mg Escalation
DBP, Any Grade Increase	6	4
DBP, Increase to Grade 2	2	1
DBP, Increase to Grade 3	0	0
SBP, Any Grade Increase	6	5
SBP, Increase to Grade 2	3	2
SBP, Increase to Grade 3	0	3

PrimaryPart 1 - Number of Participants With Worst-case Change From Baseline in Vital Signs: Pulse Rate and Body Temperature

Vital signs (pulse rate and temperature) were measured after resting for at least 5 minutes in a supine or semi-recumbent position. The abnormal vital sign ranges were: For pulse rate (low \<60 beats per minute \[bpm\] and high \>100 bpm); For body temperature (\<=35 degrees Celsius or \>=38 degrees Celsius). Baseline was defined as the most recent, non-missing value prior to or on the first study treatment dose date. Data for worst case change from baseline was presented as Baseline to low, Baseline to Normal or No change and Baseline to High.

Time frame:: Baseline (Day 1) and up to approximately 31 months
Reported as:: Count of participants · Participants

Part 1 - Number of Participants With Worst-case Change From Baseline in Vital Signs: Pulse Rate and Body Temperature
Participants	Main Study Phase- Part 1: Belantamab Mafodotin 2.5 mg/kg + Pembrolizumab 200 mg Escalation	Main Study Phase- Part 1: Belantamab Mafodotin 3.4 mg/kg + Pembrolizumab 200 mg Escalation
Pulse Rate — Baseline To Low	3	2
Pulse Rate — Baseline To Normal or No Change	3	3
Pulse Rate — Baseline To High	0	2
Temperature — Baseline To Low	0	1
Temperature — Baseline To Normal or No Change	4	6
Temperature — Baseline To High	2	0

PrimaryPart 2 - Percentage of Participants With Overall Response Rate (ORR)

ORR was defined as the percentage of participants with a confirmed partial response (PR) or better (i.e., PR, very good partial response \[VGPR\], complete response \[CR\] and stringent complete response \[sCR\]), according to the International Myeloma Working Group (IMWG) Response Criteria. CR = negative immunofixation of serum and urine AND disappearance of any soft tissue plasmacytomas AND \<5% plasmacytomas in the bone marrow; sCR=stringent complete response, CR as above PLUS normal serum free light-chain (FLC) assay ratio and absence of clonal cells in bone marrow by immunohistochemistry or immunofluorescence; VGPR = serum and urine M-component detectable by immunofixation but not on electrophoresis OR ≥ 90% reduction in serum M-component plus urine M-component \<100 mg/24 h; PR = ≥50% reduction of serum M-protein and reduction in 24-hour urinary M-protein by ≥90% or to \<200 mg/24 h.

Time frame:: Up to approximately 31 months
Reported as:: Number · Percentage of Participants

Part 2 - Percentage of Participants With Overall Response Rate (ORR)
Percentage of Participants	Main Study Phase- Part 2: Belantamab Mafodotin 2.5 mg/kg + Pembrolizumab 200 mg Expansion
Part 2 - Percentage of Participants With Overall Response Rate (ORR)	43 (24.5 to 62.8)

SecondaryPart 1 - Percentage of Participants With Overall Response Rate (ORR)

ORR was defined as the percentage of participants with a confirmed PR or better (i.e., PR, VGPR, CR and sCR), according to the IMWG Response Criteria. CR = negative immunofixation of serum and urine AND disappearance of any soft tissue plasmacytomas AND \<5% plasmacytomas in the bone marrow; sCR=stringent complete response, CR as above PLUS normal serum free light-chain (FLC) assay ratio and absence of clonal cells in bone marrow by immunohistochemistry or immunofluorescence; VGPR = serum and urine M-component detectable by immunofixation but not on electrophoresis OR \>= 90% reduction in serum M-component plus urine M-component \<100 mg/24 h; PR = \>=50% reduction of serum M-protein and reduction in 24-hour urinary M-protein by \>=90% or to \<200 mg/24 h.

Time frame:: Up to approximately 178 weeks
Reported as:: Number · Percentage of Participants

Part 1 - Percentage of Participants With Overall Response Rate (ORR)
Percentage of Participants	Main Study Phase- Part 1: Belantamab Mafodotin 2.5 mg/kg + Pembrolizumab 200 mg Escalation	Part 1: Belantamab Mafodotin 3.4 mg/kg + Pembrolizumab 200 mg Escalation
Part 1 - Percentage of Participants With Overall Response Rate (ORR)	67 (22.3 to 95.7)	43 (9.9 to 81.6)

SecondaryPart 2 - Number of Participants With AEs and SAEs

Time frame:: Up to approximately 178 weeks
Reported as:: Count of participants · Participants

Part 2 - Number of Participants With AEs and SAEs
Participants	Main Study Phase- Part 2: Belantamab Mafodotin 2.5 mg/kg + Pembrolizumab 200 mg Expansion
AEs	27
SAEs	5

SecondaryPart 2 - Number of Participants With Worst-case Grade Change From Baseline in Hematology Parameters

Blood samples were collected for the analysis of following hematology parameters: hemoglobin, White blood cell (WBC) count, lymphocytes, neutrophils and platelet. The laboratory parameters were graded according to NCI-CTCAE version 4.03. Grade 1: mild; Grade 2: moderate; Grade 3: severe or medically significant; Grade 4: life-threatening consequences. Higher grade indicates greater severity and an increase in CTCAE grade was defined relative to the Baseline grade. Baseline was defined as the most recent, non-missing value prior to or on the first study treatment dose date. Any worst case post baseline increase in grade along with any increase to a maximum grade of 3 and a maximum grade of 4 are presented.

Time frame:: Baseline (Day 1) and up to approximately 178 weeks
Reported as:: Count of participants · Participants

Part 2 - Number of Participants With Worst-case Grade Change From Baseline in Hematology Parameters
Participants	Main Study Phase- Part 2: Belantamab Mafodotin 2.5 mg/kg + Pembrolizumab 200 mg Expansion
Anemia, Any Grade Increase	10
Anemia, Increase to Grade 3	3
Anemia, Increase to Grade 4	0
Hemoglobin increased, Any Grade Increase	2
Hemoglobin increased, Increase to Grade 3	0
Hemoglobin increased, Increase to Grade 4	0
Leukocytosis, Any Grade Increase	1
Leukocytosis, Increase to Grade 3	0
Leukocytosis, Increase to Grade 4	0
WBC decreased, Any Grade Increase	11
WBC decreased, Increase to Grade 3	1
WBC decreased, Increase to Grade 4	2
Lymphocyte count decreased, Any Grade Increase	14
Lymphocyte count decreased, Increase to Grade 3	3
Lymphocyte count decreased, Increase to Grade 4	4
Lymphocyte count increased, Any Grade Increase	2
Lymphocyte count increased, Increase to Grade 3	1
Lymphocyte count increased, Increase to Grade 4	0
Neutrophil count decreased, Any Grade Increase	9
Neutrophil count decreased, Increase to Grade 3	1
Neutrophil count decreased, Increase to Grade 4	2
Platelet count decreased, Any Grade Increase	18
Platelet count decreased, Increase to Grade 3	7
Platelet count decreased, Increase to Grade 4	4

SecondaryPart 2 - Number of Participants With Worst-case Change Post-baseline in Hematology Parameters

Blood samples were collected for the analysis of following hematology parameters: basophils, eosinophils, mean corpuscular hemoglobin concentration (MCHC), mean corpuscular hemoglobin (MCH), mean corpuscular volume (MCV), Erythrocytes, hematocrit, monocytes, neutrophils and reticulocyte. The summaries of worst-case change from baseline with respect to normal range was analyzed for only those laboratory tests that were not gradable by CTCAE version 4.03. Baseline was defined as the most recent, non-missing value prior to or on the first study treatment dose date. The number of participants with decreases to low from baseline, changes to normal or no changes from baseline, and increases to high values have been presented.

Time frame:: Baseline (Day 1) and up to approximately 178 weeks
Reported as:: Count of participants · Participants

Part 2 - Number of Participants With Worst-case Change Post-baseline in Hematology Parameters
Participants	Main Study Phase- Part 2: Belantamab Mafodotin 2.5 mg/kg + Pembrolizumab 200 mg Expansion
Basophils, Decrease to Low	0
Basophils, Change to Normal or No Change	22
Basophils, Increase to High	1
Eosinophils, Decrease to Low	2
Eosinophils, Change to Normal or No Change	22
Eosinophils, Increase to High	3
MCHC, Decrease to Low	3
MCHC, Change to Normal or No Change	24
MCHC, Increase to High	0
MCH, Decrease to Low	3
MCH, Change to Normal or No Change	16
MCH, Increase to High	3
MCV, Decrease to Low	0
MCV, Change to Normal or No Change	25
MCV, Increase to High	2
Erythrocytes, Decrease to Low	0
Erythrocytes, Change to Normal or No Change	26
Erythrocytes, Increase to High	1
Hematocrit, Decrease to Low	3
Hematocrit, Change to Normal or No Change	23
Hematocrit, Increase to High	1
Monocytes, Decrease to Low	0
Monocytes, Change to Normal or No Change	20
Monocytes, Increase to High	7
Neutrophils, Segmented, Decrease to Low	0
Neutrophils, Segmented, Change to Normal or No Change	1
Neutrophils, Segmented, Increase to High	0
Reticulocytes, Decrease to Low	2
Reticulocytes, Change to Normal or No Change	14
Reticulocytes, Increase to High	5

SecondaryPart 2 - Number of Participants With Worst-case Grade Change From Baseline in Lab Chemistry Parameters

Blood samples were collected for the analysis of clinical chemistry parameters: glucose, alanine aminotransferase (ALT), albumin, alkaline phosphatase, aspartate aminotransferase (AST), blood bilirubin, calcium, creatine kinase (CPK), creatinine, gamma glutamyl transferase (GGT), magnesium, phosphate potassium and sodium. Laboratory parameters were graded according to NCI-CTCAE version 4.03. Grade 1: mild; Grade 2: moderate; Grade 3: severe or medically significant; Grade 4: life-threatening consequences. Higher grade indicates greater severity and an increase in CTCAE grade was defined relative to the Baseline grade. Baseline was defined as the most recent, non-missing value prior to or on the first study treatment dose date. Any worst case post baseline increase in grade along with any increase to a maximum grade of 3 and a maximum grade of 4 are presented.

Time frame:: Baseline (Day 1) and up to approximately 178 weeks
Reported as:: Count of participants · Participants

Part 2 - Number of Participants With Worst-case Grade Change From Baseline in Lab Chemistry Parameters
Participants	Main Study Phase- Part 2: Belantamab Mafodotin 2.5 mg/kg + Pembrolizumab 200 mg Expansion
Hyperglycemia, Any Grade Increase	1
Hyperglycemia, Increase to Grade 3	0
Hyperglycemia, Increase to Grade 4	0
Hypoglycemia, Any Grade Increase	4
Hypoglycemia, Increase to Grade 3	0
Hypoglycemia, Increase to Grade 4	0
ALT increased, Any Grade Increase	5
ALT increased, Increase to Grade 3	1
ALT increased, Increase to Grade 4	0
Hypoalbuminemia, Any Grade Increase	9
Hypoalbuminemia, Increase to Grade 3	1
Hypoalbuminemia, Increase to Grade 4	0
Alkaline phosphatase increased, Any Grade Increase	9
Alkaline phosphatase increased, Increase to Grade 3	1
Alkaline phosphatase increased, Increase to Grade 4	0
AST increased, Any Grade Increase	20
AST increased, Increase to Grade 3	1
AST increased, Increase to Grade 4	0
Blood bilirubin increased, Any Grade Increase	3
Blood bilirubin increased, Increase to Grade 3	1
Blood bilirubin increased, Increase to Grade 4	0
Hypercalcemia, Any Grade Increase	3
Hypercalcemia, Increase to Grade 3	0
Hypercalcemia, Increase to Grade 4	0
Hypocalcemia, Any Grade Increase	3
Hypocalcemia, Increase to Grade 3	0
Hypocalcemia, Increase to Grade 4	0
CPK increased, Any Grade Increase	4
CPK increased, Increase to Grade 3	1
CPK increased, Increase to Grade 4	0
Creatinine increased, Any Grade Increase	7
Creatinine increased, Increase to Grade 3	0
Creatinine increased, Increase to Grade 4	0
GGT increased, Any Grade Increase	10
GGT increased, Increase to Grade 3	1
GGT increased, Increase to Grade 4	0
Hypermagnesemia, Any Grade Increase	0
Hypermagnesemia, Increase to Grade 3	0
Hypermagnesemia, Increase to Grade 4	0
Hypomagnesemia, Any Grade Increase	6
Hypomagnesemia, Increase to Grade 3	0
Hypomagnesemia, Increase to Grade 4	0
Hypophosphatemia, Any Grade Increase	3
Hypophosphatemia, Increase to Grade 3	1
Hypophosphatemia, Increase to Grade 4	0
Hyperkalemia, Any Grade Increase	0
Hyperkalemia, Increase to Grade 3	0
Hyperkalemia, Increase to Grade 4	0
Hypokalemia, Any Grade Increase	4
Hypokalemia, Increase to Grade 3	1
Hypokalemia, Increase to Grade 4	0
Hypernatremia, Any Grade Increase	0
Hypernatremia, Increase to Grade 3	0
Hypernatremia, Increase to Grade 4	0
Hyponatremia, Any Grade Increase	3
Hyponatremia, Increase to Grade 3	1
Hyponatremia, Increase to Grade 4	0

SecondaryPart 2 - Number of Participants With Worst-case Change Post-baseline in Lab Chemistry Parameters

Blood samples were collected for the analysis of following chemistry parameters: calcium, carbon dioxide, chloride, direct bilirubin, protein, thyrotropin (TSH), thyroxine (T4) and triiodothyronine (T3). Baseline was defined as the most recent, non-missing value prior to or on the first study treatment dose date. The summaries of worst case change from baseline with respect to normal range was analyzed for only those laboratory tests that were not gradable by CTCAE version 4.03. The number of participants with decreases to low, changes to normal or no changes from baseline, and increases to high values have been presented.

Time frame:: Baseline (Day 1) and up to approximately 178 weeks
Reported as:: Count of participants · Participants

Part 2 - Number of Participants With Worst-case Change Post-baseline in Lab Chemistry Parameters
Participants	Main Study Phase- Part 2: Belantamab Mafodotin 2.5 mg/kg + Pembrolizumab 200 mg Expansion
Calcium, Decrease to Low	4
Calcium, Change to Normal or No Change	18
Calcium, Increase to High	5
Carbon Dioxide, Decrease to Low	4
Carbon Dioxide, Change to Normal or No Change	14
Carbon Dioxide, Increase to High	9
Chloride, Decrease to Low	4
Chloride, Change to Normal or No Change	20
Chloride, Increase to High	3
Direct Bilirubin, Decrease to Low	2
Direct Bilirubin, Change to Normal or No Change	15
Direct Bilirubin, Increase to High	7
Protein, Decrease to Low	8
Protein, Change to Normal or No Change	18
Protein, Increase to High	2
TSH, Decrease to Low	1
TSH, Change to Normal or No Change	17
TSH, Increase to High	8
T4, Free, Decrease to Low	2
T4, Free, Change to Normal or No Change	23
T4, Free, Increase to High	1

SecondaryPart 2 - Number of Participants With Worst-case Change Post-baseline Urinalysis Results

Urine samples were collected to assess urine glucose, protein, occult blood and ketones using dipstick method. The dipstick test gave results in a semi-quantitative manner, and results for urinalysis parameters were recorded as negative, trace, 1+, 2+, 3+ indicating proportional concentrations in the urine sample. Baseline was defined as the most recent, non-missing value prior to or on the first study treatment dose date. Result for uranalysis parameters were recorded as no change/decreased and any increase. Data for worst-case post baseline are presented.

Time frame:: Baseline (Day 1) and up to approximately 178 weeks
Reported as:: Count of participants · Participants

Part 2 - Number of Participants With Worst-case Change Post-baseline Urinalysis Results
Participants	Main Study Phase- Part 2: Belantamab Mafodotin 2.5 mg/kg + Pembrolizumab 200 mg Expansion
Glucose, No Change/Decreased	25
Glucose, Any Increase	1
Ketones, No Change/Decreased	21
Ketones, Any Increase	5
Occult Blood, No Change/Decreased	15
Occult Blood, Any Increase	9
Protein, No Change/Decreased	20
Protein, Any Increase	6

SecondaryPart 2 - Changes From Baseline in Urine Specific Gravity

Urine samples were collected from participants to assess urine specific gravity. Baseline was defined as the most recent, non-missing value prior to or on the first study treatment dose date

Time frame:: Baseline (Day 1) and until end of treatment (up to 178 weeks)
Reported as:: Mean · Ratio

Part 2 - Changes From Baseline in Urine Specific Gravity
Ratio	Main Study Phase- Part 2: Belantamab Mafodotin 2.5 mg/kg + Pembrolizumab 200 mg Expansion
Baseline	1.0171 ± 0.00965
End of Treatment	-0.0001 ± 0.00813

SecondaryPart 2 - Changes From Baseline in Urine pH

Urine samples were collected from participants to assess urine pH levels. Baseline was defined as the most recent, non-missing value prior to or on the first study treatment dose date.

Time frame:: Baseline (Day 1) and until end of treatment (up to 178 weeks)
Reported as:: Mean · Potential of Hydrogen (pH)

Part 2 - Changes From Baseline in Urine pH
Potential of Hydrogen (pH)	Main Study Phase- Part 2: Belantamab Mafodotin 2.5 mg/kg + Pembrolizumab 200 mg Expansion
Baseline	5.71 ± 0.844
End of Treatment	0.10 ± 0.687

SecondaryPart 2 - Number of Participants With Worst-case Grade Change From Baseline in Vital Signs: DBP and SBP

DBP and SBP were measured after resting for at least 5 minutes in a supine or semi-recumbent position. They were graded according to NCI-CTCAE version 4.0. For SBP: Grade 0 (\<=120 millimeter of mercury \[mmHg\]), Grade 1 (121-139 mmHg), Grade 2 (140-159 mmHg), Grade 3 (\>=160 mmHg). For DBP: Grade 0 (\<=80 mmHg), Grade 1 (81-89 mmHg), Grade 2 (90-99 mmHg), Grade 3 (\>=100 mmHg). Higher grade indicates greater severity. Baseline was defined as the most recent, non-missing value prior to or on the first study treatment dose date. An increase is defined as an increase in grade relative to Baseline grade. Data for worst-case post Baseline with any grade increase and a maximum post-baseline grade increase to Grade 3 from their baseline grade are presented.

Time frame:: Baseline (Day 1) and up to approximately 178 weeks
Reported as:: Count of participants · Participants

Part 2 - Number of Participants With Worst-case Grade Change From Baseline in Vital Signs: DBP and SBP
Participants	Main Study Phase- Part 2: Belantamab Mafodotin 2.5 mg/kg + Pembrolizumab 200 mg Expansion
DBP, Any Grade Increase	20
DBP, Increase to Grade 2	12
DBP, Increase to Grade 3	2
SBP, Any Grade Increase	24
SBP, Increase to Grade 2	16
SBP, Increase to Grade 3	6

SecondaryPart 2 - Number of Participants With Worst-case Change From Baseline in Vital Signs: Pulse Rate and Body Temperature

Vital signs (pulse rate and temperature) were measured after resting for at least 5 minutes in a supine or semi-recumbent position. The abnormal vital sign ranges were: For pulse rate (low \<60 beats per minute \[bpm\] and high \>100 bpm); For body temperature (\<=35 degrees Celsius or \>=38 degrees Celsius). Participants were counted in the worst case category that their value changed to (low, normal or high), unless there was no change in their category. Baseline was defined as the most recent, non-missing value prior to or on the first study treatment dose date.

Time frame:: Baseline (Day 1) and up to approximately 178 weeks
Reported as:: Count of participants · Participants

Part 2 - Number of Participants With Worst-case Change From Baseline in Vital Signs: Pulse Rate and Body Temperature
Participants	Main Study Phase- Part 2: Belantamab Mafodotin 2.5 mg/kg + Pembrolizumab 200 mg Expansion
Pulse Rate, To Low	10
Pulse Rate, To Normal or No Change	11
Pulse Rate, To High	7
Temperature, To Low	2
Temperature, To Normal or No Change	23
Temperature, To High	3

SecondaryPart 2 - Number of Participants With Maximum Worst-case Change From Baseline in Best Corrected Visual Acuity Test (BCVA) Scores

BCVA score was calculated based on the Logarithm of the Minimum Angle of Resolution (logMAR score). Any maximum worst-case change from baseline categories are presented for right and left eyes. No change/improved vision is defined as a change from baseline \<0.12; a possible worsened vision is defined as a change from baseline \>=0.12 to \<0.3; a definite worsened vision is defined as a change from baseline \>=0.3 logMAR score. Baseline was defined as the most recent, non-missing value prior to or on the first study treatment dose date.

Time frame:: Baseline (Day 1) and up to approximately 178 weeks
Reported as:: Count of participants · Participants

Part 2 - Number of Participants With Maximum Worst-case Change From Baseline in Best Corrected Visual Acuity Test (BCVA) Scores
Participants	Main Study Phase- Part 2: Belantamab Mafodotin 2.5 mg/kg + Pembrolizumab 200 mg Expansion
Left Eye, No change/improved vision	14
Left Eye, Possible worsened vision	5
Left Eye, Definite worsened vision	8
Right Eye, No change/improved vision	16
Right Eye, Possible worsened vision	4
Right Eye, Definite worsened vision	7

SecondaryPart 2 - Time Taken for the Onset of First Occurrence of Worsening in BCVA Score

The time for the onset of any visual acuity event (change from baseline logMAR score \>= 0.3 in either eye) was calculated.

Time frame:: Up to approximately 178 weeks
Reported as:: Median · Days

Part 2 - Time Taken for the Onset of First Occurrence of Worsening in BCVA Score
Days	Main Study Phase- Part 2: Belantamab Mafodotin 2.5 mg/kg + Pembrolizumab 200 mg Expansion
Part 2 - Time Taken for the Onset of First Occurrence of Worsening in BCVA Score	78.0 (37 to 273)

SecondaryPart 2 - Outcome of First Occurrence of Worsening Eye in BCVA Score

The onset of any visual acuity event (change from baseline in logMAR score \>= 0.3 in either eye) was considered resolved if the change from baseline in logMAR score was less than 0.3 in both eyes. Participants with resolved and not resolved outcome of the worsening eye were presented.

Time frame:: Up to approximately 178 weeks
Reported as:: Count of participants · Participants

Part 2 - Outcome of First Occurrence of Worsening Eye in BCVA Score
Participants	Main Study Phase- Part 2: Belantamab Mafodotin 2.5 mg/kg + Pembrolizumab 200 mg Expansion
Resolved prior to end of treatment exposure	7
Resolved post end of treatment exposure	2
Not resolved	1

SecondaryPart 2 - Duration of First Occurrence of Worsening in BCVA Score

The time from onset of any visual acuity event (change from baseline logMAR score \>= 0.3 in either eye) until the event is resolved (change from baseline logMAR score \< 0.3 in both eyes) was used to calculate the duration of first occurrence.

Time frame:: Up to approximately 178 weeks
Reported as:: Median · Days

Part 2 - Duration of First Occurrence of Worsening in BCVA Score
Days	Main Study Phase- Part 2: Belantamab Mafodotin 2.5 mg/kg + Pembrolizumab 200 mg Expansion
Part 2 - Duration of First Occurrence of Worsening in BCVA Score	47.0 (3 to 65)

SecondaryPart 2 - Number of Participants According to the Number of Definite Events of Worsening of Vision

A definite worsened vision was defined as a change from baseline \>=0.3 logMAR score.

Time frame:: Up to approximately 178 weeks
Reported as:: Count of participants · Participants

Part 2 - Number of Participants According to the Number of Definite Events of Worsening of Vision
Participants	Main Study Phase- Part 2: Belantamab Mafodotin 2.5 mg/kg + Pembrolizumab 200 mg Expansion
One	6
Two	1
Three or more	3

SecondaryPart 2 - Number of Participants With Resolution of Post Treatment Exposure Worsening in BCVA Score

The event was considered resolved if the change from baseline in logMAR score \< 0.3 in both eyes.

Time frame:: Up to approximately 178 weeks
Reported as:: Count of participants · Participants

Part 2 - Number of Participants With Resolution of Post Treatment Exposure Worsening in BCVA Score
Participants	Main Study Phase- Part 2: Belantamab Mafodotin 2.5 mg/kg + Pembrolizumab 200 mg Expansion
Resolved	2
Not resolved, follow-up ongoing	0
Not resolved, follow-up ended	2

SecondaryPart 2 - Duration of Resolution Post-treatment Exposure of Worsening in BCVA Score

The time taken for the resolution of worsening eye post treatment exposure. Duration was defined as the time from onset of any visual acuity event (change from baseline logMAR score \>= 0.3 in either eye) until the event was considered resolved (change from baseline logMAR score \< 0.3 in both eyes). It required at least a one day gap between the resolution of all events from first occurrence to the onset of second occurrence. The end of treatment exposure was defined as 20 days from last infusion date.

Time frame:: Up to approximately 178 weeks
Reported as:: Median · Days

Part 2 - Duration of Resolution Post-treatment Exposure of Worsening in BCVA Score
Days	Main Study Phase- Part 2: Belantamab Mafodotin 2.5 mg/kg + Pembrolizumab 200 mg Expansion
Part 2 - Duration of Resolution Post-treatment Exposure of Worsening in BCVA Score	34.5 (22 to 47)

SecondaryPart 2 - Number of Participants With Post-baseline Decline in BCVA to Light Perception or no Light Perception

Time frame:: Baseline (Day 1) and up to approximately 178 weeks

No measurements were reported for this outcome.

SecondaryPart 2 - Number of Participants With Worst-case Shift From Baseline in Ophthalmological Epithelium Exam

Participants with worst-case shift from baseline in corneal epithelium defects by right eye, left eye and worse eye are presented as normal (N), abnormal (AN) and missing. Baseline was defined as the most recent, non-missing value prior to or on the first study treatment dose date.

Time frame:: Baseline (Day 1) and up to approximately 178 weeks
Reported as:: Count of participants · Participants

Part 2 - Number of Participants With Worst-case Shift From Baseline in Ophthalmological Epithelium Exam
Participants	Main Study Phase- Part 2: Belantamab Mafodotin 2.5 mg/kg + Pembrolizumab 200 mg Expansion
Right Eye — Baseline N, Post-Baseline N	3
Right Eye — Baseline N, Post-Baseline AN	16
Right Eye — Baseline AN, Post-Baseline N	0
Right Eye — Baseline AN, Post-Baseline AN	8
Right Eye — Baseline N, Post-Baseline Missing	0
Right Eye — Baseline AN, Post-Baseline Missing	1
Left Eye — Baseline N, Post-Baseline N	2
Left Eye — Baseline N, Post-Baseline AN	16
Left Eye — Baseline AN, Post-Baseline N	1
Left Eye — Baseline AN, Post-Baseline AN	8
Left Eye — Baseline N, Post-Baseline Missing	1
Left Eye — Baseline AN, Post-Baseline Missing	0
Worse Eye — Baseline N, Post-Baseline N	3
Worse Eye — Baseline N, Post-Baseline AN	17
Worse Eye — Baseline AN, Post-Baseline N	0
Worse Eye — Baseline AN, Post-Baseline AN	7
Worse Eye — Baseline N, Post-Baseline Missing	1
Worse Eye — Baseline AN, Post-Baseline Missing	0

SecondaryPart 2 - Number of Participants With Worst-case Shift From Baseline in Corneal Examinations

Participants with worst-case shift from baseline in corneal examination: corneal ulcer, epithelial microcystic edema, subepithelial haze, corneal neovascularization and microcysts without edema, by right eye (R), left eye (L) and worse eye (W) are presented as yes (Y), no (N) and missing (M). Baseline was defined as the most recent, non-missing value prior to or on the first study treatment dose date.

Time frame:: Baseline (Day 1) and up to approximately 178 weeks
Reported as:: Count of participants · Participants

Part 2 - Number of Participants With Worst-case Shift From Baseline in Corneal Examinations
Participants	Main Study Phase- Part 2: Belantamab Mafodotin 2.5 mg/kg + Pembrolizumab 200 mg Expansion
Corneal ulcer indicator left eye — Baseline N, Post-Baseline N	23
Corneal ulcer indicator left eye — Baseline N, Post-Baseline Y	0
Corneal ulcer indicator left eye — Baseline N, Post-Baseline Missing	1
Corneal ulcer indicator left eye — Baseline Y, Post-Baseline N	0
Corneal ulcer indicator left eye — Baseline Y, Post-Baseline Y	0
Corneal ulcer indicator left eye — Baseline Y, Post-Baseline Missing	0
Corneal ulcer indicator left eye — Baseline Missing, Post-Baseline N	3
Corneal ulcer indicator left eye — Baseline Missing, Post-Baseline Y	0
Corneal ulcer indicator left eye — Baseline Missing, Post-Baseline Missing	1
Corneal ulcer indicator right eye — Baseline N, Post-Baseline N	21
Corneal ulcer indicator right eye — Baseline N, Post-Baseline Y	0
Corneal ulcer indicator right eye — Baseline N, Post-Baseline Missing	1
Corneal ulcer indicator right eye — Baseline Y, Post-Baseline N	0
Corneal ulcer indicator right eye — Baseline Y, Post-Baseline Y	0
Corneal ulcer indicator right eye — Baseline Y, Post-Baseline Missing	0
Corneal ulcer indicator right eye — Baseline Missing, Post-Baseline N	5
Corneal ulcer indicator right eye — Baseline Missing, Post-Baseline Y	0
Corneal ulcer indicator right eye — Baseline Missing, Post-Baseline Missing	1
Corneal ulcer indicator worst eye — Baseline N, Post-Baseline N	23
Corneal ulcer indicator worst eye — Baseline N, Post-Baseline Y	0
Corneal ulcer indicator worst eye — Baseline N, Post-Baseline Missing	1
Corneal ulcer indicator worst eye — Baseline Y, Post-Baseline N	0
Corneal ulcer indicator worst eye — Baseline Y, Post-Baseline Y	0
Corneal ulcer indicator worst eye — Baseline Y, Post-Baseline Missing	0
Corneal ulcer indicator worst eye — Baseline Missing, Post-Baseline N	3
Corneal ulcer indicator worst eye — Baseline Missing, Post-Baseline Y	0
Corneal ulcer indicator worst eye — Baseline Missing, Post-Baseline Missing	1
Epithelial microcystic edema indicator left eye — Baseline N, Post-Baseline N	17
Epithelial microcystic edema indicator left eye — Baseline N, Post-Baseline Y	6
Epithelial microcystic edema indicator left eye — Baseline N, Post-Baseline Missing	1
Epithelial microcystic edema indicator left eye — Baseline Y, Post-Baseline N	0
Epithelial microcystic edema indicator left eye — Baseline Y, Post-Baseline Y	0
Epithelial microcystic edema indicator left eye — Baseline Y, Post-Baseline Missing	0
Epithelial microcystic edema indicator left eye — Baseline Missing, Post-Baseline N	2
Epithelial microcystic edema indicator left eye — Baseline Missing, Post-Baseline Y	1
Epithelial microcystic edema indicator left eye — Baseline Missing, Post-Baseline Missing	1
Epithelial microcystic edema indicator right eye — Baseline N, Post-Baseline N	16
Epithelial microcystic edema indicator right eye — Baseline N, Post-Baseline Y	5
Epithelial microcystic edema indicator right eye — Baseline N, Post-Baseline Missing	1
Epithelial microcystic edema indicator right eye — Baseline Y, Post-Baseline N	0
Epithelial microcystic edema indicator right eye — Baseline Y, Post-Baseline Y	0
Epithelial microcystic edema indicator right eye — Baseline Y, Post-Baseline Missing	0
Epithelial microcystic edema indicator right eye — Baseline Missing, Post-Baseline N	3
Epithelial microcystic edema indicator right eye — Baseline Missing, Post-Baseline Y	2
Epithelial microcystic edema indicator right eye — Baseline Missing, Post-Baseline Missing	1
Epithelial microcystic edema indicator worst eye — Baseline N, Post-Baseline N	17
Epithelial microcystic edema indicator worst eye — Baseline N, Post-Baseline Y	6
Epithelial microcystic edema indicator worst eye — Baseline N, Post-Baseline Missing	1
Epithelial microcystic edema indicator worst eye — Baseline Y, Post-Baseline N	0
Epithelial microcystic edema indicator worst eye — Baseline Y, Post-Baseline Y	0
Epithelial microcystic edema indicator worst eye — Baseline Y, Post-Baseline Missing	0
Epithelial microcystic edema indicator worst eye — Baseline Missing, Post-Baseline N	2
Epithelial microcystic edema indicator worst eye — Baseline Missing, Post-Baseline Y	1
Epithelial microcystic edema indicator worst eye — Baseline Missing, Post-Baseline Missing	1
Microcysts without edema indicator left eye — Baseline N, Post-Baseline N	8
Microcysts without edema indicator left eye — Baseline N, Post-Baseline Y	15
Microcysts without edema indicator left eye — Baseline N, Post-Baseline Missing	1
Microcysts without edema indicator left eye — Baseline Y, Post-Baseline N	0
Microcysts without edema indicator left eye — Baseline Y, Post-Baseline Y	0
Microcysts without edema indicator left eye — Baseline Y, Post-Baseline Missing	0
Microcysts without edema indicator left eye — Baseline Missing, Post-Baseline N	0
Microcysts without edema indicator left eye — Baseline Missing, Post-Baseline Y	3
Microcysts without edema indicator left eye — Baseline Missing, Post-Baseline Missing	1
Microcysts without edema indicator right eye — Baseline N, Post-Baseline N	7
Microcysts without edema indicator right eye — Baseline N, Post-Baseline Y	14
Microcysts without edema indicator right eye — Baseline N, Post-Baseline Missing	1
Microcysts without edema indicator right eye — Baseline Y, Post-Baseline N	0
Microcysts without edema indicator right eye — Baseline Y, Post-Baseline Y	0
Microcysts without edema indicator right eye — Baseline Y, Post-Baseline Missing	0
Microcysts without edema indicator right eye — Baseline Missing, Post-Baseline N	1
Microcysts without edema indicator right eye — Baseline Missing, Post-Baseline Y	4
Microcysts without edema indicator right eye — Baseline Missing, Post-Baseline Missing	1
Microcysts without edema indicator worst eye — Baseline N, Post-Baseline N	8
Microcysts without edema indicator worst eye — Baseline N, Post-Baseline Y	15
Microcysts without edema indicator worst eye — Baseline N, Post-Baseline Missing	1
Microcysts without edema indicator worst eye — Baseline Y, Post-Baseline N	0
Microcysts without edema indicator worst eye — Baseline Y, Post-Baseline Y	0
Microcysts without edema indicator worst eye — Baseline Y, Post-Baseline Missing	0
Microcysts without edema indicator worst eye — Baseline Missing, Post-Baseline N	0
Microcysts without edema indicator worst eye — Baseline Missing, Post-Baseline Y	3
Microcysts without edema indicator worst eye — Baseline Missing, Post-Baseline Missing	1
Corneal neovascularization indicator left eye — Baseline N, Post-Baseline N	22
Corneal neovascularization indicator left eye — Baseline N, Post-Baseline Y	1
Corneal neovascularization indicator left eye — Baseline N, Post-Baseline Missing	2
Corneal neovascularization indicator left eye — Baseline Y, Post-Baseline N	0
Corneal neovascularization indicator left eye — Baseline Y, Post-Baseline Y	0
Corneal neovascularization indicator left eye — Baseline Y, Post-Baseline Missing	0
Corneal neovascularization indicator left eye — Baseline Missing, Post-Baseline N	2
Corneal neovascularization indicator left eye — Baseline Missing, Post-Baseline Y	1
Corneal neovascularization indicator left eye — Baseline Missing, Post-Baseline Missing	0
Corneal neovascularization indicator right eye — Baseline N, Post-Baseline N	20
Corneal neovascularization indicator right eye — Baseline N, Post-Baseline Y	1
Corneal neovascularization indicator right eye — Baseline N, Post-Baseline Missing	2
Corneal neovascularization indicator right eye — Baseline Y, Post-Baseline N	0
Corneal neovascularization indicator right eye — Baseline Y, Post-Baseline Y	1
Corneal neovascularization indicator right eye — Baseline Y, Post-Baseline Missing	0
Corneal neovascularization indicator right eye — Baseline Missing, Post-Baseline N	3
Corneal neovascularization indicator right eye — Baseline Missing, Post-Baseline Y	1
Corneal neovascularization indicator right eye — Baseline Missing, Post-Baseline Missing	0
Corneal neovascularization indicator worst eye — Baseline N, Post-Baseline N	21
Corneal neovascularization indicator worst eye — Baseline N, Post-Baseline Y	1
Corneal neovascularization indicator worst eye — Baseline N, Post-Baseline Missing	2
Corneal neovascularization indicator worst eye — Baseline Y, Post-Baseline N	0
Corneal neovascularization indicator worst eye — Baseline Y, Post-Baseline Y	1
Corneal neovascularization indicator worst eye — Baseline Y, Post-Baseline Missing	0
Corneal neovascularization indicator worst eye — Baseline Missing, Post-Baseline N	2
Corneal neovascularization indicator worst eye — Baseline Missing, Post-Baseline Y	1
Corneal neovascularization indicator worst eye — Baseline Missing, Post-Baseline Missing	0
Subepithelial haze indicator left eye — Baseline N, Post-Baseline N	16
Subepithelial haze indicator left eye — Baseline N, Post-Baseline Y	9
Subepithelial haze indicator left eye — Baseline N, Post-Baseline Missing	1
Subepithelial haze indicator left eye — Baseline Y, Post-Baseline N	1
Subepithelial haze indicator left eye — Baseline Y, Post-Baseline Y	0
Subepithelial haze indicator left eye — Baseline Y, Post-Baseline Missing	0
Subepithelial haze indicator left eye — Baseline Missing, Post-Baseline N	1
Subepithelial haze indicator left eye — Baseline Missing, Post-Baseline Y	0
Subepithelial haze indicator left eye — Baseline Missing, Post-Baseline Missing	0
Subepithelial haze indicator right eye — Baseline N, Post-Baseline N	16
Subepithelial haze indicator right eye — Baseline N, Post-Baseline Y	8
Subepithelial haze indicator right eye — Baseline N, Post-Baseline Missing	1
Subepithelial haze indicator right eye — Baseline Y, Post-Baseline N	1
Subepithelial haze indicator right eye — Baseline Y, Post-Baseline Y	0
Subepithelial haze indicator right eye — Baseline Y, Post-Baseline Missing	0
Subepithelial haze indicator right eye — Baseline Missing, Post-Baseline N	2
Subepithelial haze indicator right eye — Baseline Missing, Post-Baseline Y	0
Subepithelial haze indicator right eye — Baseline Missing, Post-Baseline Missing	0
Subepithelial haze indicator worst eye — Baseline N, Post-Baseline N	17
Subepithelial haze indicator worst eye — Baseline N, Post-Baseline Y	9
Subepithelial haze indicator worst eye — Baseline N, Post-Baseline Missing	1
Subepithelial haze indicator worst eye — Baseline Y, Post-Baseline N	0
Subepithelial haze indicator worst eye — Baseline Y, Post-Baseline Y	0
Subepithelial haze indicator worst eye — Baseline Y, Post-Baseline Missing	0
Subepithelial haze indicator worst eye — Baseline Missing, Post-Baseline N	1
Subepithelial haze indicator worst eye — Baseline Missing, Post-Baseline Y	0
Subepithelial haze indicator worst eye — Baseline Missing, Post-Baseline Missing	0

SecondaryPart 2 - Number of Participants With Worse Case Post-baseline Punctate Keratopathy Findings

Participants with worse case punctate keratopathy findings post baseline at any ocular exam by right eye, left eye and worse eye are presented as none, mild, moderate and severe. Worse eye indicates the eye with the worst visual acuity. Baseline was defined as the most recent, non-missing value prior to or on the first study treatment dose date.

Time frame:: Baseline (Day 1) and up to approximately 178 weeks
Reported as:: Count of participants · Participants

Part 2 - Number of Participants With Worse Case Post-baseline Punctate Keratopathy Findings
Participants	Main Study Phase- Part 2: Belantamab Mafodotin 2.5 mg/kg + Pembrolizumab 200 mg Expansion
Right eye, Worst findings — None	2
Right eye, Worst findings — Mild	11
Right eye, Worst findings — Moderate	7
Right eye, Worst findings — Severe	6
Left eye, Worst findings — None	2
Left eye, Worst findings — Mild	9
Left eye, Worst findings — Moderate	9
Left eye, Worst findings — Severe	6
Worst eye, Worst findings — None	2
Worst eye, Worst findings — Mild	8
Worst eye, Worst findings — Moderate	10
Worst eye, Worst findings — Severe	6
Right eye, Most frequent findings — None	10
Right eye, Most frequent findings — Mild	14
Right eye, Most frequent findings — Moderate	2
Right eye, Most frequent findings — Severe	0
Left eye, Most frequent findings — None	8
Left eye, Most frequent findings — Mild	13
Left eye, Most frequent findings — Moderate	5
Left eye, Most frequent findings — Severe	0
Worst eye, Most frequent findings — None	7
Worst eye, Most frequent findings — Mild	14
Worst eye, Most frequent findings — Moderate	5
Worst eye, Most frequent findings — Severe	0

SecondaryPart 2 - Number of Participants With Worst-case Shift From Baseline in Lens Examinations

Participants with worst-case shift from baseline in corneal examination which included: clear, pseudophakia, nuclear sclerosis, cortical cataract and posterior subcapsular cataract by right eye, left eye and worse eye are presented as yes (Y), no (N) and missing. Baseline was defined as the most recent, non-missing value prior to or on the first study treatment dose date.

Time frame:: Baseline (Day 1) and up to approximately 178 weeks
Reported as:: Count of participants · Participants

Part 2 - Number of Participants With Worst-case Shift From Baseline in Lens Examinations
Participants	Main Study Phase- Part 2: Belantamab Mafodotin 2.5 mg/kg + Pembrolizumab 200 mg Expansion
Clear Indicator, Left eye — Baseline N, Post-Baseline N	12
Clear Indicator, Left eye — Baseline N, Post-Baseline Y	0
Clear Indicator, Left eye — Baseline N, Post-Baseline N=Missing	3
Clear Indicator, Left eye — Baseline Y, Post-Baseline N	3
Clear Indicator, Left eye — Baseline Y, Post-Baseline Y	10
Clear Indicator, Left eye — Baseline Y, Post-Baseline Missing	0
Clear Indicator, Left eye — Baseline Missing, Post-Baseline N	0
Clear Indicator, Left eye — Baseline Missing, Post-Baseline Y	0
Clear Indicator, Left eye — Baseline Missing, Post-Baseline Missing	0
Clear Indicator, Right eye — Baseline N, Post-Baseline N	12
Clear Indicator, Right eye — Baseline N, Post-Baseline Y	0
Clear Indicator, Right eye — Baseline N, Post-Baseline N=Missing	3
Clear Indicator, Right eye — Baseline Y, Post-Baseline N	3
Clear Indicator, Right eye — Baseline Y, Post-Baseline Y	10
Clear Indicator, Right eye — Baseline Y, Post-Baseline Missing	0
Clear Indicator, Right eye — Baseline Missing, Post-Baseline N	0
Clear Indicator, Right eye — Baseline Missing, Post-Baseline Y	0
Clear Indicator, Right eye — Baseline Missing, Post-Baseline Missing	0
Clear Indicator, worse eye — Baseline N, Post-Baseline N	12
Clear Indicator, worse eye — Baseline N, Post-Baseline Y	0
Clear Indicator, worse eye — Baseline N, Post-Baseline N=Missing	3
Clear Indicator, worse eye — Baseline Y, Post-Baseline N	3
Clear Indicator, worse eye — Baseline Y, Post-Baseline Y	10
Clear Indicator, worse eye — Baseline Y, Post-Baseline Missing	0
Clear Indicator, worse eye — Baseline Missing, Post-Baseline N	0
Clear Indicator, worse eye — Baseline Missing, Post-Baseline Y	0
Clear Indicator, worse eye — Baseline Missing, Post-Baseline Missing	0
Cortical Cataract Indicator, Left eye — Baseline N, Post-Baseline N	7
Cortical Cataract Indicator, Left eye — Baseline N, Post-Baseline Y	3
Cortical Cataract Indicator, Left eye — Baseline N, Post-Baseline N=Missing	2
Cortical Cataract Indicator, Left eye — Baseline Y, Post-Baseline N	0
Cortical Cataract Indicator, Left eye — Baseline Y, Post-Baseline Y	2
Cortical Cataract Indicator, Left eye — Baseline Y, Post-Baseline Missing	1
Cortical Cataract Indicator, Left eye — Baseline Missing, Post-Baseline N	2
Cortical Cataract Indicator, Left eye — Baseline Missing, Post-Baseline Y	1
Cortical Cataract Indicator, Left eye — Baseline Missing, Post-Baseline Missing	10
Cortical Cataract Indicator, Right eye — Baseline N, Post-Baseline N	7
Cortical Cataract Indicator, Right eye — Baseline N, Post-Baseline Y	3
Cortical Cataract Indicator, Right eye — Baseline N, Post-Baseline N=Missing	1
Cortical Cataract Indicator, Right eye — Baseline Y, Post-Baseline N	0
Cortical Cataract Indicator, Right eye — Baseline Y, Post-Baseline Y	2
Cortical Cataract Indicator, Right eye — Baseline Y, Post-Baseline Missing	2
Cortical Cataract Indicator, Right eye — Baseline Missing, Post-Baseline N	3
Cortical Cataract Indicator, Right eye — Baseline Missing, Post-Baseline Y	0
Cortical Cataract Indicator, Right eye — Baseline Missing, Post-Baseline Missing	10
Cortical Cataract Indicator, Worse eye — Baseline N, Post-Baseline N	7
Cortical Cataract Indicator, Worse eye — Baseline N, Post-Baseline Y	3
Cortical Cataract Indicator, Worse eye — Baseline N, Post-Baseline N=Missing	2
Cortical Cataract Indicator, Worse eye — Baseline Y, Post-Baseline N	0
Cortical Cataract Indicator, Worse eye — Baseline Y, Post-Baseline Y	2
Cortical Cataract Indicator, Worse eye — Baseline Y, Post-Baseline Missing	1
Cortical Cataract Indicator, Worse eye — Baseline Missing, Post-Baseline N	2
Cortical Cataract Indicator, Worse eye — Baseline Missing, Post-Baseline Y	1
Cortical Cataract Indicator, Worse eye — Baseline Missing, Post-Baseline Missing	10
Nuclear Sclerosis, Left eye — Baseline N, Post-Baseline N	2
Nuclear Sclerosis, Left eye — Baseline N, Post-Baseline Y	1
Nuclear Sclerosis, Left eye — Baseline N, Post-Baseline N=Missing	0
Nuclear Sclerosis, Left eye — Baseline Y, Post-Baseline N	1
Nuclear Sclerosis, Left eye — Baseline Y, Post-Baseline Y	8
Nuclear Sclerosis, Left eye — Baseline Y, Post-Baseline Missing	3
Nuclear Sclerosis, Left eye — Baseline Missing, Post-Baseline N	2
Nuclear Sclerosis, Left eye — Baseline Missing, Post-Baseline Y	1
Nuclear Sclerosis, Left eye — Baseline Missing, Post-Baseline Missing	10
Nuclear Sclerosis, Right eye — Baseline N, Post-Baseline N	2
Nuclear Sclerosis, Right eye — Baseline N, Post-Baseline Y	1
Nuclear Sclerosis, Right eye — Baseline N, Post-Baseline N=Missing	0
Nuclear Sclerosis, Right eye — Baseline Y, Post-Baseline N	1
Nuclear Sclerosis, Right eye — Baseline Y, Post-Baseline Y	8
Nuclear Sclerosis, Right eye — Baseline Y, Post-Baseline Missing	3
Nuclear Sclerosis, Right eye — Baseline Missing, Post-Baseline N	3
Nuclear Sclerosis, Right eye — Baseline Missing, Post-Baseline Y	0
Nuclear Sclerosis, Right eye — Baseline Missing, Post-Baseline Missing	10
Nuclear Sclerosis, Worse eye — Baseline N, Post-Baseline N	2
Nuclear Sclerosis, Worse eye — Baseline N, Post-Baseline Y	1
Nuclear Sclerosis, Worse eye — Baseline N, Post-Baseline N=Missing	0
Nuclear Sclerosis, Worse eye — Baseline Y, Post-Baseline N	1
Nuclear Sclerosis, Worse eye — Baseline Y, Post-Baseline Y	8
Nuclear Sclerosis, Worse eye — Baseline Y, Post-Baseline Missing	3
Nuclear Sclerosis, Worse eye — Baseline Missing, Post-Baseline N	2
Nuclear Sclerosis, Worse eye — Baseline Missing, Post-Baseline Y	1
Nuclear Sclerosis, Worse eye — Baseline Missing, Post-Baseline Missing	10
Posterior Subcapsular Cataract, Left eye — Baseline N, Post-Baseline N	7
Posterior Subcapsular Cataract, Left eye — Baseline N, Post-Baseline Y	3
Posterior Subcapsular Cataract, Left eye — Baseline N, Post-Baseline N=Missing	0
Posterior Subcapsular Cataract, Left eye — Baseline Y, Post-Baseline N	0
Posterior Subcapsular Cataract, Left eye — Baseline Y, Post-Baseline Y	2
Posterior Subcapsular Cataract, Left eye — Baseline Y, Post-Baseline Missing	3
Posterior Subcapsular Cataract, Left eye — Baseline Missing, Post-Baseline N	1
Posterior Subcapsular Cataract, Left eye — Baseline Missing, Post-Baseline Y	2
Posterior Subcapsular Cataract, Left eye — Baseline Missing, Post-Baseline Missing	10
Posterior Subcapsular Cataract, Right eye — Baseline N, Post-Baseline N	7
Posterior Subcapsular Cataract, Right eye — Baseline N, Post-Baseline Y	1
Posterior Subcapsular Cataract, Right eye — Baseline N, Post-Baseline N=Missing	0
Posterior Subcapsular Cataract, Right eye — Baseline Y, Post-Baseline N	0
Posterior Subcapsular Cataract, Right eye — Baseline Y, Post-Baseline Y	4
Posterior Subcapsular Cataract, Right eye — Baseline Y, Post-Baseline Missing	3
Posterior Subcapsular Cataract, Right eye — Baseline Missing, Post-Baseline N	1
Posterior Subcapsular Cataract, Right eye — Baseline Missing, Post-Baseline Y	2
Posterior Subcapsular Cataract, Right eye — Baseline Missing, Post-Baseline Missing	10
Posterior Subcapsular Cataract, Worse eye — Baseline N, Post-Baseline N	6
Posterior Subcapsular Cataract, Worse eye — Baseline N, Post-Baseline Y	3
Posterior Subcapsular Cataract, Worse eye — Baseline N, Post-Baseline N=Missing	0
Posterior Subcapsular Cataract, Worse eye — Baseline Y, Post-Baseline N	0
Posterior Subcapsular Cataract, Worse eye — Baseline Y, Post-Baseline Y	4
Posterior Subcapsular Cataract, Worse eye — Baseline Y, Post-Baseline Missing	3
Posterior Subcapsular Cataract, Worse eye — Baseline Missing, Post-Baseline N	1
Posterior Subcapsular Cataract, Worse eye — Baseline Missing, Post-Baseline Y	1
Posterior Subcapsular Cataract, Worse eye — Baseline Missing, Post-Baseline Missing	10
Pseudophakia, Left eye — Baseline N, Post-Baseline N	11
Pseudophakia, Left eye — Baseline N, Post-Baseline Y	3
Pseudophakia, Left eye — Baseline N, Post-Baseline N=Missing	3
Pseudophakia, Left eye — Baseline Y, Post-Baseline N	1
Pseudophakia, Left eye — Baseline Y, Post-Baseline Y	10
Pseudophakia, Left eye — Baseline Y, Post-Baseline Missing	0
Pseudophakia, Left eye — Baseline Missing, Post-Baseline N	0
Pseudophakia, Left eye — Baseline Missing, Post-Baseline Y	0
Pseudophakia, Left eye — Baseline Missing, Post-Baseline Missing	0
Pseudophakia, Right eye — Baseline N, Post-Baseline N	12
Pseudophakia, Right eye — Baseline N, Post-Baseline Y	2
Pseudophakia, Right eye — Baseline N, Post-Baseline N=Missing	3
Pseudophakia, Right eye — Baseline Y, Post-Baseline N	1
Pseudophakia, Right eye — Baseline Y, Post-Baseline Y	10
Pseudophakia, Right eye — Baseline Y, Post-Baseline Missing	0
Pseudophakia, Right eye — Baseline Missing, Post-Baseline N	0
Pseudophakia, Right eye — Baseline Missing, Post-Baseline Y	0
Pseudophakia, Right eye — Baseline Missing, Post-Baseline Missing	0
Pseudophakia, Worse eye — Baseline N, Post-Baseline N	11
Pseudophakia, Worse eye — Baseline N, Post-Baseline Y	4
Pseudophakia, Worse eye — Baseline N, Post-Baseline N=Missing	3
Pseudophakia, Worse eye — Baseline Y, Post-Baseline N	0
Pseudophakia, Worse eye — Baseline Y, Post-Baseline Y	10
Pseudophakia, Worse eye — Baseline Y, Post-Baseline Missing	0
Pseudophakia, Worse eye — Baseline Missing, Post-Baseline N	0
Pseudophakia, Worse eye — Baseline Missing, Post-Baseline Y	0
Pseudophakia, Worse eye — Baseline Missing, Post-Baseline Missing	0

SecondaryPart 2 - Percentage of Participants With Clinical Benefit Rate

Clinical benefit rate was defined as the percentage of participants with a confirmed minimal response (MR) or better according to the IMWG Response Criteria. MR is \>= 25% but \< 49% reduction of serum M-protein and reduction in 24-hour urinary M-protein by 50-89%.

Time frame:: Up to approximately 178 weeks
Reported as:: Number · Percentage of Participants

Part 2 - Percentage of Participants With Clinical Benefit Rate
Percentage of Participants	Main Study Phase- Part 2: Belantamab Mafodotin 2.5 mg/kg + Pembrolizumab 200 mg Expansion
Part 2 - Percentage of Participants With Clinical Benefit Rate	43 (24.5 to 62.8)

SecondaryPart 2 - Duration of Response

Duration of response was defined as the time from first documented evidence of PR or better, to the time when disease progression (PD) is documented per IMWG response criteria; or death due to PD occurs among participants who achieve an overall response, i.e. confirmed PR or better. PD= Increase of 25% from lowest confirmed response value in 1 or more of the following criteria: Serum M-protein with absolute increase of \>= 0.5 g/dL; Serum M-protein increase \>= 1 g/dL if the lowest M-component was \>=5 g/dL; Urinary M-protein (absolute increase must be \>= 200 mg per 24 h). PR = ≥50% reduction of serum M-protein and reduction in 24-hour urinary M-protein by ≥ 90% or to \<200 mg/24 h.

Time frame:: Up to approximately 178 weeks
Reported as:: Median · Months

Part 2 - Duration of Response
Months	Main Study Phase- Part 2: Belantamab Mafodotin 2.5 mg/kg + Pembrolizumab 200 mg Expansion
Part 2 - Duration of Response	7.6 (1.4 to NA)

SecondaryPart 2 - Time to Response

Time to response (TTR) was defined as the time between the date of first dose and the first documented evidence of response (PR or better) among participants who achieved a confirmed response of PR or better.

Time frame:: Up to approximately 178 weeks
Reported as:: Median · Months

Part 2 - Time to Response
Months	Main Study Phase- Part 2: Belantamab Mafodotin 2.5 mg/kg + Pembrolizumab 200 mg Expansion
Part 2 - Time to Response	0.7 (0.7 to 1.4)

SecondaryPart 2 - Time to Best Response

Time to best response was defined as the time between the date of first dose and the first best documented response (PR or better) among participants who achieved a confirmed response of PR or better.

Time frame:: Up to approximately 178 weeks
Reported as:: Median · Months

Part 2 - Time to Best Response
Months	Main Study Phase- Part 2: Belantamab Mafodotin 2.5 mg/kg + Pembrolizumab 200 mg Expansion
Part 2 - Time to Best Response	1.7 (0.7 to 5.6)

SecondaryPart 2 - Progression-free Survival

Progression-free survival was defined as the time from first dose until the earliest date of PD per IMWG response criteria, or death due to any cause. PD= Increase of 25% from lowest confirmed response value in 1 or more of the following criteria: Serum M-protein with absolute increase of \>= 0.5 g/dL; Serum M-protein increase \>= 1 g/dL if the lowest M-component was \>=5 g/dL; Urinary M-protein (absolute increase must be \>= 200 mg per 24 h).

Time frame:: Up to approximately 178 weeks
Reported as:: Median · Months

Part 2 - Progression-free Survival
Months	Main Study Phase- Part 2: Belantamab Mafodotin 2.5 mg/kg + Pembrolizumab 200 mg Expansion
Part 2 - Progression-free Survival	2.5 (0.8 to 5.6)

SecondaryPart 2 - Time to Disease Progression

Time to disease progression was defined as the time from first dose until the earliest date of PD per IMWG response criteria, or death due to PD. PD= Increase of 25% from lowest confirmed response value in 1 or more of the following criteria: Serum M-protein with absolute increase of \>= 0.5 g/dL; Serum M-protein increase \>= 1 g/dL if the lowest M-component was \>=5 g/dL; Urinary M-protein (absolute increase must be \>= 200 mg per 24 h).

Time frame:: Up to approximately 178 weeks
Reported as:: Median · Months

Part 2 - Time to Disease Progression
Months	Main Study Phase- Part 2: Belantamab Mafodotin 2.5 mg/kg + Pembrolizumab 200 mg Expansion
Part 2 - Time to Disease Progression	2.5 (0.8 to 5.6)

SecondaryPart 2 - Overall Survival

Overall Survival was defined as the time from first dose until death due to any cause.

Time frame:: Up to approximately 178 weeks
Reported as:: Median · Months

Part 2 - Overall Survival
Months	Main Study Phase- Part 2: Belantamab Mafodotin 2.5 mg/kg + Pembrolizumab 200 mg Expansion
Part 2 - Overall Survival	NA (19.1 to NA)

SecondaryPart 1 - Maximum Concentration (Cmax) for Belantamab Mafodotin After First Dose

Blood samples were collected for Pharmacokinetic (PK) analysis of belantamab mafodotin when administered intravenously in combination with pembrolizumab. PK parameter was determined using standard non-compartmental methods.

Time frame:: Pre-dose, end of infusion (EOI), 2, 4, 9, and 24 h post-SOI (start of infusion) on Cycle 1 Day 1, Cycle 1 Day 4, Cycle 1 Day 8, and pre-dose on Cycle 2 Day 1

No measurements were reported for this outcome.

SecondaryPart 2 - Cmax for Belantamab Mafodotin After First Dose

Time frame:: Pre-dose, EOI, 2, 4, 9, and 24 h post-SOI on Cycle 1 Day 1, Cycle 1 Day 4, Cycle 1 Day 8, and pre-dose on Cycle 2 Day 1

No measurements were reported for this outcome.

SecondaryPart 1 - End of Infusion Concentration (C-EOI) for Belantamab Mafodotin

Time frame:: EOI post belantamab mafodotin dose on Day 1 of each 21 day Cycle till Cycle 11

No measurements were reported for this outcome.

SecondaryPart 2 - C-EOI for Belantamab Mafodotin

Time frame:: EOI post belantamab mafodotin dose on Day 1 of each 21 day Cycle till Cycle 11

No measurements were reported for this outcome.

SecondaryPart 1 - Time of Cmax (Tmax) for Belantamab Mafodotin After First Dose

Time frame:: Pre-dose, EOI, 2, 4, 9, and 24 h post-SOI on Cycle 1 Day 1, Cycle 1 Day 4, Cycle 1 Day 8, and pre-dose on Cycle 2 Day 1

No measurements were reported for this outcome.

SecondaryPart 2 - Tmax for Belantamab Mafodotin After First Dose

Time frame:: Pre-dose, EOI, 2, 4, 9, and 24 h post-SOI on Cycle 1 Day 1, Cycle 1 Day 4, Cycle 1 Day 8, and pre-dose on Cycle 2 Day 1

No measurements were reported for this outcome.

SecondaryPart 1 - Trough Concentration Prior to the Next Dose for Each Cycle (Ctrough) for Belantamab Mafodotin

Blood samples were collected for PK analysis of belantamab mafodotin when administered intravenously in combination with pembrolizumab. Ctrough was calculated as the observed concentration at the end of a dosing interval, immediately before next study drug administration on Day 1 of each Cycle. PK parameter was determined using standard non-compartmental methods.

Time frame:: Pre-dose on Day 1 of each 21 day cycle from Cycle 1 until Cycle 13

No measurements were reported for this outcome.

SecondaryPart 2 - Ctrough for Belantamab Mafodotin

Time frame:: Pre-dose on Day 1 of each 21 day cycle from Cycle 1 until Cycle 13

No measurements were reported for this outcome.

SecondaryPart 1 - Last Time Point Where the Concentration is Above the Limit of Quantification (Tlast) for Belantamab Mafodotin After First Dose

Time frame:: Pre-dose, EOI, 2, 4, 9, and 24 h post-SOI on Cycle 1 Day 1, Cycle 1 Day 4, Cycle 1 Day 8, and pre-dose on Cycle 2 Day 1

No measurements were reported for this outcome.

SecondaryPart 2 - Tlast for Belantamab Mafodotin After First Dose

Time frame:: Pre-dose, EOI, 2, 4, 9, and 24 h post-SOI on Cycle 1 Day 1, Cycle 1 Day 4, Cycle 1 Day 8, and pre-dose on Cycle 2 Day 1

No measurements were reported for this outcome.

SecondaryPart 1 - Area Under Plasma Concentration-time Curve (AUC) From Time 0 to End of the Dosing Interval [AUC (0-tau)] for Belantamab Mafodotin After First Dose

Time frame:: Pre-dose, EOI, 2, 4, 9, and 24 h post-SOI on Cycle 1 Day 1, Cycle 1 Day 4, Cycle 1 Day 8, and pre-dose on Cycle 2 Day 1

No measurements were reported for this outcome.

SecondaryPart 2 - AUC (0-tau) for Belantamab Mafodotin After First Dose

Time frame:: Pre-dose, EOI, 2, 4, 9, and 24 h post-SOI on Cycle 1 Day 1, Cycle 1 Day 4, Cycle 1 Day 8, and pre-dose on Cycle 2 Day 1

No measurements were reported for this outcome.

SecondaryPart 1 - Cmax for Total Monoclonal Antibody (mAb) After First Dose

Time frame:: Pre-dose, EOI, 2, 4, 9, and 24 hour post-SOI on Cycle 1 Day 1, Cycle 1 Day 4, Cycle 1 Day 8, and pre-dose on Cycle 2 Day 1
Reported as:: Geometric mean · ug/mL

Part 1 - Cmax for Total Monoclonal Antibody (mAb) After First Dose
ug/mL	Main Study Phase- Part 1: Belantamab Mafodotin 2.5 mg/kg + Pembrolizumab 200 mg Escalation	Part 1: Belantamab Mafodotin 3.4 mg/kg + Pembrolizumab 200 mg Escalation
Part 1 - Cmax for Total Monoclonal Antibody (mAb) After First Dose	43.57 ± 7.1	64.45 ± 21.5

SecondaryPart 2 - Cmax for Total mAb After First Dose

Time frame:: Pre-dose, EOI, 2, 4, and 24 hour post-SOI on Cycle 1 Day 1, Cycle 1 Day 4, Cycle 1 Day 8, and pre-dose on Cycle 2 Day 1
Reported as:: Geometric mean · ug/mL

Part 2 - Cmax for Total mAb After First Dose
ug/mL	Main Study Phase- Part 2: Belantamab Mafodotin 2.5 mg/kg + Pembrolizumab 200 mg Expansion
Part 2 - Cmax for Total mAb After First Dose	46.70 ± 23.3

SecondaryPart 1 - C-EOI for Total mAb

Time frame:: EOI post belantamab mafodotin dose on Day 1 of Cycle 1, Cycle 2, Cycle 5, Cycle 8, and Cycle 11
Reported as:: Median · ug/mL

Part 1 - C-EOI for Total mAb
ug/mL	Main Study Phase- Part 1: Belantamab Mafodotin 2.5 mg/kg + Pembrolizumab 200 mg Escalation	Part 1: Belantamab Mafodotin 3.4 mg/kg + Pembrolizumab 200 mg Escalation
Cycle 1	40.15 (36.3 to 44.4)	65.30 (44.6 to 73.5)
Cycle 2	53.90 (39.1 to 66.3)	64.65 (16.1 to 90.1)
Cycle 5	54.65 (46.5 to 78.2)	73.90 (42.6 to 101.0)
Cycle 8	63.70 (63.70 to 63.70)	39.75 (12.9 to 66.6)
Cycle 11	65.40 (65.40 to 65.40)	54.80 (54.80 to 54.80)

SecondaryPart 2 - C-EOI for Total mAb

Time frame:: EOI post belantamab mafodotin dose on Day 1 of Cycle 1, Cycle 2, and Cycle 5
Reported as:: Median · ug/mL

Part 2 - C-EOI for Total mAb
ug/mL	Main Study Phase- Part 2: Belantamab Mafodotin 2.5 mg/kg + Pembrolizumab 200 mg Expansion
Cycle 1	48.60 (17.4 to 68.9)
Cycle 2	53.00 (26.5 to 71.1)
Cycle 5	52.35 (36.9 to 70.5)

SecondaryPart 1 - Tmax for Total mAb After First Dose

Time frame:: Pre-dose, EOI, 2, 4, 9, and 24 hour post-SOI on Cycle 1 Day 1, Cycle 1 Day 4, Cycle 1 Day 8, and pre-dose on Cycle 2 Day 1
Reported as:: Median · Hour

Part 1 - Tmax for Total mAb After First Dose
Hour	Main Study Phase- Part 1: Belantamab Mafodotin 2.5 mg/kg + Pembrolizumab 200 mg Escalation	Part 1: Belantamab Mafodotin 3.4 mg/kg + Pembrolizumab 200 mg Escalation
Part 1 - Tmax for Total mAb After First Dose	1.100 (0.53 to 2.18)	1.520 (0.75 to 2.05)

SecondaryPart 2 - Tmax for Total mAb After First Dose

Time frame:: Pre-dose, EOI, 2, 4, and 24 hour post-SOI on Cycle 1 Day 1, Cycle 1 Day 4, Cycle 1 Day 8, and pre-dose on Cycle 2 Day 1
Reported as:: Median · Hour

Part 2 - Tmax for Total mAb After First Dose
Hour	Main Study Phase- Part 2: Belantamab Mafodotin 2.5 mg/kg + Pembrolizumab 200 mg Expansion
Part 2 - Tmax for Total mAb After First Dose	0.945 (0.47 to 2.33)

SecondaryPart 1 - Ctrough for Total mAb

Time frame:: Cycle 1, Cycle 4, Cycle 7, Cycle 10, and Cycle 13
Reported as:: Median · ug/mL

Part 1 - Ctrough for Total mAb
ug/mL	Main Study Phase- Part 1: Belantamab Mafodotin 2.5 mg/kg + Pembrolizumab 200 mg Escalation	Part 1: Belantamab Mafodotin 3.4 mg/kg + Pembrolizumab 200 mg Escalation
Cycle 1	5.420 (3.85 to 7.87)	13.350 (1.83 to 13.50)
Cycle 4	8.91 (0 to 30.8)	18.80 (18.1 to 19.5)
Cycle 7	26.90 (26.9 to 26.9)	45.05 (23.9 to 66.2)
Cycle 10	18.40 (18.4 to 18.4)	21.70 (21.7 to 21.7)
Cycle 13	18.05 (18.0 to 18.1)	—

SecondaryPart 2 - Ctrough for Total mAb

Time frame:: Cycle 1 and Cycle 4
Reported as:: Median · ug/mL

Part 2 - Ctrough for Total mAb
ug/mL	Main Study Phase- Part 2: Belantamab Mafodotin 2.5 mg/kg + Pembrolizumab 200 mg Expansion
Cycle 1	7.735 (1.28 to 12.70)
Cycle 4	11.60 (9.15 to 31.0)

SecondaryPart 1 - Last Time Point Where the Concentration is Above the Limit of Quantification (Tlast) for Total mAb After First Dose

Blood samples were collected for PK analysis of belantamab mafodotin when administered intravenously in combination with pembrolizumab. PK parameter was determined using standard non-compartmental methods. Tlast is the time of last observed quantifiable concentration of belantamab mafodotin in Cycle 1 which extended beyond protocol defined duration for some participants across treatment groups.

Time frame:: Pre-dose, EOI, 2, 4, 9, and 24 hour post-SOI on Cycle 1 Day 1, Cycle 1 Day 4, Cycle 1 Day 8, and pre-dose on Cycle 2 Day 1
Reported as:: Median · Hour

Part 1 - Last Time Point Where the Concentration is Above the Limit of Quantification (Tlast) for Total mAb After First Dose
Hour	Main Study Phase- Part 1: Belantamab Mafodotin 2.5 mg/kg + Pembrolizumab 200 mg Escalation	Part 1: Belantamab Mafodotin 3.4 mg/kg + Pembrolizumab 200 mg Escalation
Part 1 - Last Time Point Where the Concentration is Above the Limit of Quantification (Tlast) for Total mAb After First Dose	501.800 (70.03 to 507.23)	481.580 (72.27 to 551.80)

SecondaryPart 2 - Tlast for Total mAb After First Dose

Time frame:: Pre-dose, EOI, 2, 4, and 24 hour post-SOI on Cycle 1 Day 1, Cycle 1 Day 4, Cycle 1 Day 8, and pre-dose on Cycle 2 Day 1
Reported as:: Median · Hour

Part 2 - Tlast for Total mAb After First Dose
Hour	Main Study Phase- Part 2: Belantamab Mafodotin 2.5 mg/kg + Pembrolizumab 200 mg Expansion
Part 2 - Tlast for Total mAb After First Dose	503.140 (72.50 to 2060.68)

SecondaryPart 1 - AUC (0-tau) for Total mAb After First Dose

Time frame:: Pre-dose, EOI, 2, 4, 9, and 24 hour post-SOI on Cycle 1 Day 1, Cycle 1 Day 4, Cycle 1 Day 8, and pre-dose on Cycle 2 Day 1
Reported as:: Geometric mean · h*ug/mL

Part 1 - AUC (0-tau) for Total mAb After First Dose
h*ug/mL	Main Study Phase- Part 1: Belantamab Mafodotin 2.5 mg/kg + Pembrolizumab 200 mg Escalation	Part 1: Belantamab Mafodotin 3.4 mg/kg + Pembrolizumab 200 mg Escalation
Part 1 - AUC (0-tau) for Total mAb After First Dose	6237.2 ± 17.9	10817.8 ± 48.5

SecondaryPart 2 - AUC (0-tau) for Total mAb After First Dose

Time frame:: Pre-dose, EOI, 2, 4, and 24 hour post-SOI on Cycle 1 Day 1, Cycle 1 Day 4, Cycle 1 Day 8, and pre-dose on Cycle 2 Day 1
Reported as:: Geometric mean · h*ug/mL

Part 2 - AUC (0-tau) for Total mAb After First Dose
h*ug/mL	Main Study Phase- Part 2: Belantamab Mafodotin 2.5 mg/kg + Pembrolizumab 200 mg Expansion
Part 2 - AUC (0-tau) for Total mAb After First Dose	7949.0 ± 27.2

SecondaryPart 1 - Cmax for Cysteine Maleimidocaproyl Monomethyl Auristatin F (Cys-mcMMAF) After First Dose

Time frame:: Pre-dose, EOI, 2, 4, 9, and 24 hour post-SOI on Cycle 1 Day 1, Cycle 1 Day 4, Cycle 1 Day 8, and pre-dose on Cycle 2 Day 1
Reported as:: Geometric mean · ng/mL

Part 1 - Cmax for Cysteine Maleimidocaproyl Monomethyl Auristatin F (Cys-mcMMAF) After First Dose
ng/mL	Main Study Phase- Part 1: Belantamab Mafodotin 2.5 mg/kg + Pembrolizumab 200 mg Escalation	Part 1: Belantamab Mafodotin 3.4 mg/kg + Pembrolizumab 200 mg Escalation
Part 1 - Cmax for Cysteine Maleimidocaproyl Monomethyl Auristatin F (Cys-mcMMAF) After First Dose	1.5799 ± 30.4	1.0966 ± 40.9

SecondaryPart 2 - Cmax for Cys-mcMMAF After First Dose

Time frame:: Pre-dose, EOI, 2, 4, and 24 hour post-SOI on Cycle 1 Day 1, Cycle 1 Day 4, Cycle 1 Day 8, and pre-dose on Cycle 2 Day 1
Reported as:: Geometric mean · ng/mL

Part 2 - Cmax for Cys-mcMMAF After First Dose
ng/mL	Main Study Phase- Part 2: Belantamab Mafodotin 2.5 mg/kg + Pembrolizumab 200 mg Expansion
Part 2 - Cmax for Cys-mcMMAF After First Dose	1.2481 ± 111.5

SecondaryPart 1 - C-EOI for Cys-mcMMAF After First Dose

Time frame:: EOI post belantamab mafodotin dose on Day 1 of Cycle 1
Reported as:: Median · ng/mL

Part 1 - C-EOI for Cys-mcMMAF After First Dose
ng/mL	Main Study Phase- Part 1: Belantamab Mafodotin 2.5 mg/kg + Pembrolizumab 200 mg Escalation	Part 1: Belantamab Mafodotin 3.4 mg/kg + Pembrolizumab 200 mg Escalation
Part 1 - C-EOI for Cys-mcMMAF After First Dose	0.7110 (0.342 to 1.080)	0.7630 (0.169 to 1.980)

SecondaryPart 2 - C-EOI for Cys-mcMMAF After First Dose

Time frame:: EOI post belantamab mafodotin dose on Day 1 of Cycle 1
Reported as:: Median · ng/mL

Part 2 - C-EOI for Cys-mcMMAF After First Dose
ng/mL	Main Study Phase- Part 2: Belantamab Mafodotin 2.5 mg/kg + Pembrolizumab 200 mg Expansion
Part 2 - C-EOI for Cys-mcMMAF After First Dose	0.3150 (0.131 to 20.300)

SecondaryPart 1 - Tmax for Cys-mcMMAF After First Dose

Time frame:: Pre-dose, EOI, 2, 4, 9, and 24 hour post-SOI on Cycle 1 Day 1, Cycle 1 Day 4, Cycle 1 Day 8, and pre-dose on Cycle 2 Day 1
Reported as:: Median · Hour

Part 1 - Tmax for Cys-mcMMAF After First Dose
Hour	Main Study Phase- Part 1: Belantamab Mafodotin 2.5 mg/kg + Pembrolizumab 200 mg Escalation	Part 1: Belantamab Mafodotin 3.4 mg/kg + Pembrolizumab 200 mg Escalation
Part 1 - Tmax for Cys-mcMMAF After First Dose	13.510 (4.05 to 22.97)	4.120 (0.57 to 73.03)

SecondaryPart 2 - Tmax for Cys-mcMMAF After First Dose

Time frame:: Pre-dose, EOI, 2, 4, and 24 hour post-SOI on Cycle 1 Day 1, Cycle 1 Day 4, Cycle 1 Day 8, and pre-dose on Cycle 2 Day 1
Reported as:: Median · Hour

Part 2 - Tmax for Cys-mcMMAF After First Dose
Hour	Main Study Phase- Part 2: Belantamab Mafodotin 2.5 mg/kg + Pembrolizumab 200 mg Expansion
Part 2 - Tmax for Cys-mcMMAF After First Dose	23.580 (0.52 to 70.65)

SecondaryPart 1 - Tlast for Cys-mcMMAF After First Dose

Time frame:: Pre-dose, EOI, 2, 4, 9, and 24 hour post-SOI on Cycle 1 Day 1, Cycle 1 Day 4, Cycle 1 Day 8, and pre-dose on Cycle 2 Day 1
Reported as:: Median · Hour

Part 1 - Tlast for Cys-mcMMAF After First Dose
Hour	Main Study Phase- Part 1: Belantamab Mafodotin 2.5 mg/kg + Pembrolizumab 200 mg Escalation	Part 1: Belantamab Mafodotin 3.4 mg/kg + Pembrolizumab 200 mg Escalation
Part 1 - Tlast for Cys-mcMMAF After First Dose	161.380 (70.03 to 168.13)	171.250 (72.27 to 501.28)

SecondaryPart 2 - Tlast for Cys-mcMMAF After First Dose

Time frame:: Pre-dose, EOI, 2, 4, and 24 hour post-SOI on Cycle 1 Day 1, Cycle 1 Day 4, Cycle 1 Day 8, and pre-dose on Cycle 2 Day 1
Reported as:: Median · Hour

Part 2 - Tlast for Cys-mcMMAF After First Dose
Hour	Main Study Phase- Part 2: Belantamab Mafodotin 2.5 mg/kg + Pembrolizumab 200 mg Expansion
Part 2 - Tlast for Cys-mcMMAF After First Dose	167.510 (23.90 to 503.15)

SecondaryPart 1 - AUC From Time 0 to 168 h After Dosing [AUC (0-168h)] for Cys-mcMMAF After First Dose

Time frame:: Pre-dose, EOI, 2, 4, 9, and 24 hour post-SOI on Cycle 1 Day 1, Cycle 1 Day 4, and Cycle 1 Day 8
Reported as:: Geometric mean · h*ug/mL

Part 1 - AUC From Time 0 to 168 h After Dosing [AUC (0-168h)] for Cys-mcMMAF After First Dose
h*ug/mL	Main Study Phase- Part 1: Belantamab Mafodotin 2.5 mg/kg + Pembrolizumab 200 mg Escalation	Part 1: Belantamab Mafodotin 3.4 mg/kg + Pembrolizumab 200 mg Escalation
Part 1 - AUC From Time 0 to 168 h After Dosing [AUC (0-168h)] for Cys-mcMMAF After First Dose	155.27	90.61 ± 34.5

SecondaryPart 2 - AUC (0-168 h) for Cys-mcMMAF After First Dose

Time frame:: Pre-dose, EOI, 2, 4, and 24 hour post-SOI on Cycle 1 Day 1, Cycle 1 Day 4, and Cycle 1 Day 8
Reported as:: Geometric mean · h*ug/mL

Part 2 - AUC (0-168 h) for Cys-mcMMAF After First Dose
h*ug/mL	Main Study Phase- Part 2: Belantamab Mafodotin 2.5 mg/kg + Pembrolizumab 200 mg Expansion
Part 2 - AUC (0-168 h) for Cys-mcMMAF After First Dose	128.38 ± 70.9

SecondaryPart 1 - Cmax for Pembrolizumab After First Dose

Time frame:: Pre-dose, EOI, 2, 4, 9, and 24 h post-SOI on Cycle 1 Day 1, Cycle 1 Day 4, Cycle 1 Day 8, and pre-dose on Cycle 2 Day 1

No measurements were reported for this outcome.

SecondaryPart 2 - Cmax for Pembrolizumab After First Dose

Time frame:: Pre-dose, EOI, 2, 4, 9, and 24 h post-SOI on Cycle 1 Day 1, Cycle 1 Day 4, Cycle 1 Day 8, and pre-dose on Cycle 2 Day 1

No measurements were reported for this outcome.

SecondaryPart 1 - Tmax for Pembrolizumab After First Dose

Time frame:: Pre-dose, EOI, 2, 4, 9, and 24 h post-SOI on Cycle 1 Day 1, Cycle 1 Day 4, Cycle 1 Day 8, and pre-dose on Cycle 2 Day 1

No measurements were reported for this outcome.

SecondaryPart 2 - Tmax for Pembrolizumab After First Dose

Time frame:: Pre-dose, EOI, 2, 4, 9, and 24 h post-SOI on Cycle 1 Day 1, Cycle 1 Day 4, Cycle 1 Day 8, and pre-dose on Cycle 2 Day 1

No measurements were reported for this outcome.

SecondaryPart 1 - AUC (0-tau) for Pembrolizumab After First Dose

Time frame:: Pre-dose, EOI, 2, 4, 9, and 24 h post-SOI on Cycle 1 Day 1, Cycle 1 Day 4, Cycle 1 Day 8, and pre-dose on Cycle 2 Day 1

No measurements were reported for this outcome.

SecondaryPart 2 - AUC (0-tau) for Pembrolizumab After First Dose

Time frame:: Pre-dose, EOI, 2, 4, 9, and 24 h post-SOI on Cycle 1 Day 1, Cycle 1 Day 4, Cycle 1 Day 8, and pre-dose on Cycle 2 Day 1

No measurements were reported for this outcome.

SecondaryPart 1 - Number of Participants With Post-baseline Positive Anti-drug Antibodies (ADAs) Against Belantamab Mafodotin

Serum samples collected for the analysis of the presence of ADAs using validated immunoassays. All samples were tested in screening assay, and positive samples were further characterized for antibody titers. At the time of primary results posting, there was no participants with positive ADA results. Baseline was defined as the most recent, non-missing value prior to or on the first study treatment dose date.

Time frame:: Baseline (Day 1) and until end of treatment (up to 178 weeks)
Reported as:: Count of participants · Participants

Part 1 - Number of Participants With Post-baseline Positive Anti-drug Antibodies (ADAs) Against Belantamab Mafodotin
Participants	Main Study Phase- Part 1: Belantamab Mafodotin 2.5 mg/kg + Pembrolizumab 200 mg Escalation	Part 1: Belantamab Mafodotin 3.4 mg/kg + Pembrolizumab 200 mg Escalation
Baseline	0	0
End of Treatment	0	0

SecondaryPart 2 - Number of Participants With Post-baseline Positive ADAs Against Belantamab Mafodotin

Time frame:: Baseline (Day 1) and until end of treatment (up to 178 weeks)
Reported as:: Count of participants · Participants

Part 2 - Number of Participants With Post-baseline Positive ADAs Against Belantamab Mafodotin
Participants	Main Study Phase- Part 2: Belantamab Mafodotin 2.5 mg/kg + Pembrolizumab 200 mg Expansion
Baseline	0
End of Treatment	0

SecondaryPart 1 - Titers of ADAs Against Belantamab Mafodotin

Serum samples collected for the analysis of the presence of ADAs using validated immunoassays. All samples were to be further tested in screening assay, and positive samples were further to be characterized for antibody titers.

Time frame:: Up to approximately 178 weeks

No measurements were reported for this outcome.

SecondaryPart 2 - Titers of ADAs Against Belantamab Mafodotin

Time frame:: Baseline (Day 1) and up to approximately 178 weeks

No measurements were reported for this outcome.

Adverse events

Collected over All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from day 1 to week 178 for Main Study Phase and from week 178 to week 221 for PACT phase.. Non-serious events are listed at a 5% frequency threshold.

Adverse event summary by group
Group	Deaths	Serious	Other
Main Study Phase- Part 1: Belantamab Mafodotin 2.5 mg/kg + Pembrolizumab 200 mg Escalation	2/6 (33.3%)	4/6 (66.7%)	6/6 (100%)
Main Study Phase- Part 1: Belantamab Mafodotin 3.4 mg/kg + Pembrolizumab 200 mg Escalation	3/7 (42.9%)	5/7 (71.4%)	6/7 (85.7%)
Main Study Phase- Part 2: Belantamab Mafodotin 2.5 mg/kg + Pembrolizumab 200 mg Expansion	7/28 (25%)	5/28 (17.9%)	27/28 (96.4%)
PACT Phase- Belantamab Mafodotin 2.5 mg/kg + Pembrolizumab 200 mg	0/2 (0%)	0/2 (0%)	0/2 (0%)

Most frequent serious events

Showing 10 of 27

Most frequent serious events
Event	Main Study Phase- Part 1: Belantamab Mafodotin 2.5 mg/kg + Pembrolizumab 200 mg Escalation	Main Study Phase- Part 1: Belantamab Mafodotin 3.4 mg/kg + Pembrolizumab 200 mg Escalation	Main Study Phase- Part 2: Belantamab Mafodotin 2.5 mg/kg + Pembrolizumab 200 mg Expansion	PACT Phase- Belantamab Mafodotin 2.5 mg/kg + Pembrolizumab 200 mg
Urinary tract infectionInfections and infestations	2/6	0/7	0/28	0/2
Febrile neutropeniaBlood and lymphatic system disorders	1/6	0/7	0/28	0/2
Cytokine release syndromeImmune system disorders	1/6	0/7	0/28	0/2
PneumoniaInfections and infestations	1/6	1/7	4/28	0/2
Femur fractureInjury, poisoning and procedural complications	1/6	0/7	0/28	0/2
Infusion related reactionInjury, poisoning and procedural complications	1/6	0/7	2/28	0/2
Basal cell carcinomaNeoplasms benign, malignant and unspecified (incl cysts and polyps)	1/6	0/7	0/28	0/2
Cardiopulmonary failureCardiac disorders	0/6	1/7	0/28	0/2
Large intestinal haemorrhageGastrointestinal disorders	0/6	1/7	0/28	0/2
Anaphylactic reactionImmune system disorders	0/6	1/7	0/28	0/2

Most frequent other events

Showing 10 of 34

Most frequent other events
Event	Main Study Phase- Part 1: Belantamab Mafodotin 2.5 mg/kg + Pembrolizumab 200 mg Escalation	Main Study Phase- Part 1: Belantamab Mafodotin 3.4 mg/kg + Pembrolizumab 200 mg Escalation	Main Study Phase- Part 2: Belantamab Mafodotin 2.5 mg/kg + Pembrolizumab 200 mg Expansion	PACT Phase- Belantamab Mafodotin 2.5 mg/kg + Pembrolizumab 200 mg
KeratopathyEye disorders	6/6	6/7	20/28	0/2
AnaemiaBlood and lymphatic system disorders	4/6	3/7	5/28	0/2
PyrexiaGeneral disorders	1/6	4/7	10/28	0/2
ThrombocytopeniaBlood and lymphatic system disorders	3/6	3/7	9/28	0/2
BlepharitisEye disorders	3/6	0/7	0/28	0/2
Dry eyeEye disorders	3/6	1/7	4/28	0/2
Vision blurredEye disorders	3/6	2/7	10/28	0/2
NauseaGastrointestinal disorders	3/6	1/7	7/28	0/2
FatigueGeneral disorders	3/6	3/7	3/28	0/2
CoughRespiratory, thoracic and mediastinal disorders	3/6	2/7	2/28	0/2

Baseline characteristics

Age, Continuous
Age, Continuous(YEARS)	Main Study Phase- Part 1: Belantamab Mafodotin 2.5 mg/kg + Pembrolizumab 200 mg Escalation	Main Study Phase- Part 1: Belantamab Mafodotin 3.4 mg/kg + Pembrolizumab 200 mg Escalation	Main Study Phase- Part 2: Belantamab Mafodotin 2.5 mg/kg + Pembrolizumab 200 mg Expansion	Total
Mean	66.8 ± 12.09	67.7 ± 9.21	61.5 ± 9.41	63.3 ± 9.92

Sex: Female, Male
Sex: Female, Male(Participants)	Main Study Phase- Part 1: Belantamab Mafodotin 2.5 mg/kg + Pembrolizumab 200 mg Escalation	Main Study Phase- Part 1: Belantamab Mafodotin 3.4 mg/kg + Pembrolizumab 200 mg Escalation	Main Study Phase- Part 2: Belantamab Mafodotin 2.5 mg/kg + Pembrolizumab 200 mg Expansion	Total
Female	5	4	10	19
Male	1	3	18	22

Race/Ethnicity, Customized
Race/Ethnicity, Customized(Participants)	Main Study Phase- Part 1: Belantamab Mafodotin 2.5 mg/kg + Pembrolizumab 200 mg Escalation	Main Study Phase- Part 1: Belantamab Mafodotin 3.4 mg/kg + Pembrolizumab 200 mg Escalation	Main Study Phase- Part 2: Belantamab Mafodotin 2.5 mg/kg + Pembrolizumab 200 mg Expansion	Total
Asian	0	0	1	1
Black OR African American	1	2	4	7
White	5	5	23	33

Study locations

12 sites

GSK Investigational Site
Atlanta, Georgia 30322, United States
GSK Investigational Site
Indianapolis, Indiana 46202, United States
GSK Investigational Site
Charlotte, North Carolina 28204, United States
GSK Investigational Site
Madison, Wisconsin 53792, United States
GSK Investigational Site
Calgary, Alberta T2N 2T9, Canada
GSK Investigational Site
Toronto, Ontario M5G 2M9, Canada
GSK Investigational Site
Hanover, Lower Saxony 30625, Germany
GSK Investigational Site
Berlin, 12200, Germany
GSK Investigational Site
Hamburg, 20246, Germany
GSK Investigational Site
Badalona, 08916, Spain
GSK Investigational Site
Pozuelo de Alarcón/Madrid, 28223, Spain
GSK Investigational Site
Salamanca, 37007, Spain

References and documents

Publications

Suvannasankha A, Bahlis N, Trudel S, Weisel K, Koenecke C, Oriol A, Voorhees PM, Alonso AA, Callander NS, Mateos MV, Reddy N, Hakim S, LaMacchia J, Patel N, Williams D, Jewell RC, Zhou X, Gupta I, Opalinska J, Nooka AK. Safety and efficacy of belantamab mafodotin with pembrolizumab in patients with relapsed or refractory multiple myeloma. Cancer. 2024 Aug 1;130(15):2629-2641. doi: 10.1002/cncr.35319. Epub 2024 Apr 17. PubMed 38630908 ↗

Study documents

Study protocol · Feb 21, 2022
Statistical analysis plan · Aug 29, 2022

Documents are hosted by the registry — open the source record to download them.

Individual participant data

Plan to share: Yes — IPD for this study will be made available via the Clinical Study Data Request site.

Supporting information: Study protocol, Statistical analysis plan, Informed consent form, Clinical study report

Time frame: IPD will be made available within 6 months of publishing the results of the primary endpoints, key secondary endpoints and safety data of the study.

Access criteria: Access is provided after a research proposal is submitted and has received approval from the Independent Review Panel and after a Data Sharing Agreement is in place. Access is provided for an initial period of 12 months but an extension can be granted, when justified, for up to another 12 months.

Data sharing details ↗ · clinicalstudydatarequest.com

Timeline

Tracking since Sep 25, 2026

ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Mar 2019 to primary completion in Oct 2021, 31 months.

Results were first posted in Dec 2022, 1 year 2 months after primary completion.

Of 99 industry-sponsored phase 1/2 interventional studies under Multiple Myeloma, half reached primary completion within 64 months of starting (the median), counting those still running; a quarter within 40 and three quarters within 86. This study's 31 months is below that.

Counting every sponsor, half of 201 studies reached it within 64 months; a quarter within 44 and three quarters within 90.

How these figures are worked out, and which studies are left out of them.

Registered: Feb 19, 2019
First posted: Feb 21, 2019
StartActual: Mar 14, 2019
Primary completionActual: Oct 18, 2021
CompletionActual: Jun 14, 2023
Results first posted: Dec 23, 2022
Last update: Apr 9, 2024

What these dates mean

Start.: When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.: When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.: When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.: Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.

No changes since tracking began. The registry record was last updated on Apr 9, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT03848845
Lead sponsor: GlaxoSmithKline
Collaborators: Merck Sharp & Dohme LLC
Responsible party: Sponsor
First posted: Feb 21, 2019
Start date: Mar 14, 2019
Primary completion: Oct 18, 2021
Completion: Jun 14, 2023
Results posted: Dec 23, 2022
Last update: Apr 9, 2024

Study contacts

GSK Clinical Trials

study director · GlaxoSmithKline

Oversight

Data monitoring committee: No
FDA-regulated drug: Yes
FDA-regulated device: No

View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Mar 2024. You cannot join it, but the record below documents what was studied.

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Discussion

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Studies of the drug tested here: Pembrolizumab

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Study Evaluating Safety, Tolerability and Clinical Activity of GSK2857916 in Combination With Pembrolizumab in Subjects With Relapsed/Refractory Multiple Myeloma (RRMM)

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