A Phase 1 interventional study of Boserolimab and Pembrolizumab in Pharmacokinetics, Solid Tumor and Carcinoma, Non-Small-Cell Lung, sponsored by Merck Sharp & Dohme LLC. Completed at 18 sites in 7 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-11-05.
Sponsored by Merck Sharp & Dohme LLC (part of Merck & Co., Inc) · Phase 1, Interventional, and Treatment
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Among 91 studies in Carcinoma, Non-Small-Cell Lung by Merck & Co., Inc — 14 open to participants now, 26 under way, 18 of them phase 3. Carcinoma, Non-Small-Cell Lung · Merck & Co., Inc.
Among the 91 studies in Carcinoma, Non-Small-Cell Lung by Merck & Co., Inc, this one is the 40th largest by enrollment of the 88 interventional ones that give a count, is one of 6 that started in 2018, is one of 19 in phase 1, and was the 42nd registered.
7,624 studies on the registry are indexed under Carcinoma, Non-Small-Cell Lung; 1,837 are open to participants now.
Browse Carcinoma, Non-Small-Cell Lung studies →14 of the 91 studies in Carcinoma, Non-Small-Cell Lung by Merck & Co., Inc are open now, in 12 countries. Recruiting first, the newest first:
Merck Sharp & Dohme LLC · Sites in United States, Argentina, Australia and 15 more countries
Ages 18+
Merck Sharp & Dohme LLC · Sites in United States, Australia, Brazil and 17 more countries
Ages 18+
Merck Sharp & Dohme LLC · Sites in Argentina, Australia, Brazil and 16 more countries
Ages 18+
Merck Sharp & Dohme LLC · Sites in United States, Argentina, Australia and 8 more countries
Ages 18+
Merck Sharp & Dohme LLC · Sites in United States, Argentina, Australia and 27 more countries
Ages 18+
By country, each count listing its studies:
Of the 1,326 Carcinoma, Non-Small-Cell Lung studies recruiting now, 988 (75%) set no upper age limit and 225 (17%) stop at 75 or younger; 34 take children under 18; 40 take healthy volunteers.
This study: 18 Years and older · all sexes · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
91 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 23 · Phase 2 30 · Phase 3 40 · Phase 4 1
First in 2000; this study’s year is marked. 6 started in 2018.
By drug class, each counting the studies that test any of its medicines:
This study's enrollment of 182 is above the median of 62 across 6,023 interventional studies indexed under Carcinoma, Non-Small-Cell Lung.
Median enrollment 149 across the 88 interventional studies, 600 across the 3 observational. Of the 65 that completed or were terminated, 49 (75%) have results posted.
This tab as a report to print or save as PDF → With an account.
This study is registered under Merck Sharp & Dohme LLC, one of the names counted as Merck & Co., Inc. Under that name alone:
Merck Sharp & Dohme LLC is the lead sponsor of 2,166 studies on the registry; 131 are open to participants now.
Of its 503 completed or terminated interventional studies of FDA-regulated products, 371 (74%) have results posted.
3 of the studies in Carcinoma, Non-Small-Cell Lung by Merck & Co., Inc that are under way reach primary completion within a year, 3 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT05609968Phase 3Merck Sharp & Dohme LLCStudy of Pembrolizumab (MK-3475) Monotherapy Versus Sacituzumab Govitecan in Combination With Pembrolizumab for Participants With Metastatic Non-small Cell Lung Cancer (NSCLC) With Programmed Cell Death Ligand 1 (PD-L1) Tumor Proportion Score (TPS) ≥50% (MK-3475-D46) | 2027-01-12 |
| NCT04380636Phase 3Merck Sharp & Dohme LLCStudy of Pembrolizumab With Concurrent Chemoradiation Therapy Followed by Pembrolizumab With or Without Olaparib in Stage III Non-Small Cell Lung Cancer (NSCLC) (MK-7339-012/KEYLYNK-012) | 2027-05-05 |
| NCT06074588Phase 3Merck Sharp & Dohme LLCSacituzumab Tirumotecan (MK-2870) Versus Chemotherapy in Previously Treated Advanced or Metastatic Nonsquamous Non-small Cell Lung Cancer (NSCLC) With EGFR Mutations or Other Genomic Alterations (MK-2870-004) | 2027-05-10 |
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Among the 91 studies in Carcinoma, Non-Small-Cell Lung by Merck & Co., Inc, from their registry updates:
This tab as a report to print or save as PDF → With an account.
The purpose of this study is to assess the safety and pharmacokinetics of boserolimab (MK-5890) when administered alone and in combination with pembrolizumab (MK-3475) in adults. Boserolimab monotherapy or boserolimab plus pembrolizumab combination therapy will be administered in adults with advanced solid tumors, including endometrial cancer, for up to 35 administrations (approximately 2 years). The safety and pharmacokinetics of boserolimab when administered with pembrolizumab, pemetrexed and carboplatin in adults with non-squamous non-small cell lung cancer (NSCLC) and boserolimab when administered with pembrolizumab and nab-paclitaxel in adults with triple-negative breast cancer (TNBC) will also be assessed.
Participants receiving boserolimab monotherapy who experience disease progression may be eligible to switch to receiving boserolimab plus pembrolizumab combination therapy at an eligible dose for up to 35 cycles (approximately 2 years) at the discretion of the Investigator and approval of the Sponsor.
Per protocol, pharmacokinetic (PK) outcome measures will not be analyzed separately for the switch-over treatment arms.
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.
Exclusion Criteria:
Additional Exclusion Criteria for Participants in Arm 3:
Additional Exclusion Criteria for Participants in Arm 4:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The diagnosis was confirmed by looking at a sample under a microscope: tissue from a biopsy or surgery (histology), or cells from a fluid or needle sample (cytology).
Your pathology report is the document that shows this.
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
The amount of disease can be tracked with a defined measurement, so the study can see whether it shrinks or grows. It might be a tumour measured on a scan or, in some blood cancers such as myeloma, a marker measured in blood or urine.
The criteria or the study team say which measurement counts — having no tumour visible on a scan does not by itself rule you out.
The standard rules for measuring tumours on CT or MRI scans, to tell whether a cancer is shrinking, stable or growing during treatment.
“Measurable disease per RECIST 1.1” usually means at least one tumour 10 mm or more at its longest on a CT scan, or a lymph node 15 mm or more across its short axis.
A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.
Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.
Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
PD-1, PD-L1 and CTLA-4 are proteins that act as brakes on the immune system. Checkpoint inhibitors, such as pembrolizumab or nivolumab, block them so the immune system can attack a cancer.
PD-L1 can also be measured in a tumour sample. Some scores count stained tumour cells only (TPS); others also count certain immune cells (CPS). The study names the score and the minimum it uses.
Histologically or cytologically confirmed
The diagnosis was confirmed by looking at a sample under a microscope: tissue from a biopsy or surgery (histology), or cells from a fluid or needle sample (cytology).
Your pathology report is the document that shows this.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Metastases
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Measurable disease
The amount of disease can be tracked with a defined measurement, so the study can see whether it shrinks or grows. It might be a tumour measured on a scan or, in some blood cancers such as myeloma, a marker measured in blood or urine.
The criteria or the study team say which measurement counts — having no tumour visible on a scan does not by itself rule you out.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
RECIST
The standard rules for measuring tumours on CT or MRI scans, to tell whether a cancer is shrinking, stable or growing during treatment.
“Measurable disease per RECIST 1.1” usually means at least one tumour 10 mm or more at its longest on a CT scan, or a lymph node 15 mm or more across its short axis.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ECOG performance status
A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.
Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Biopsy and archival tissue
A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.
Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Autoimmune disease
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis B tests
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
PD-1, PD-L1 and checkpoint inhibitors
PD-1, PD-L1 and CTLA-4 are proteins that act as brakes on the immune system. Checkpoint inhibitors, such as pembrolizumab or nivolumab, block them so the immune system can attack a cancer.
PD-L1 can also be measured in a tumour sample. Some scores count stained tumour cells only (TPS); others also count certain immune cells (CPS). The study names the score and the minimum it uses.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participants receive boserolimab 2 mg via intravenous (IV) infusion once every 3 weeks (Q3W) on Day 1 of each cycle for a total of up to approximately 35 cycles (up to approximately 2 years). Each cycle is 3 weeks long.
Drug: Boserolimab
Participants receive boserolimab 7 mg via IV infusion once Q3W on Day 1 of each cycle for a total of up to approximately 35 cycles (up to approximately 2 years). Each cycle is 3 weeks long.
Drug: Boserolimab
Participants receive boserolimab 20 mg via IV infusion once Q3W on Day 1 of each cycle for a total of up to approximately 35 cycles (up to approximately 2 years). Each cycle is 3 weeks long.
Drug: Boserolimab
Participants receive boserolimab 70 mg via IV infusion once Q3W on Day 1 of each cycle for a total of up to approximately 35 cycles (up to approximately 2 years). Each cycle is 3 weeks long.
Drug: Boserolimab
Participants receive boserolimab 200 mg via IV infusion once Q3W on Day 1 of each cycle for a total of up to approximately 35 cycles (up to approximately 2 years). Each cycle is 3 weeks long.
Drug: Boserolimab
Participants receive boserolimab 700 mg via IV infusion once Q3W on Day 1 of each cycle for a total of up to approximately 35 cycles (up to approximately 2 years). Each cycle is 3 weeks long.
Drug: Boserolimab
Participants with endometrial cancer receive boserolimab 30 mg via IV infusion once Q3W on Day 1 of each cycle for a total of up to approximately 35 cycles (up to approximately 2 years). Each cycle is 3 weeks long.
Drug: Boserolimab
Participants receive separate IV infusions of boserolimab 2 mg and pembrolizumab 200 mg. Boserolimab and pembrolizumab are administered once Q3W on Day 1 of each cycle for a total of up to approximately 35 cycles (up to approximately 2 years). Each cycle is 3 weeks long.
Drug: Boserolimab · Biological: Pembrolizumab
Participants receive separate IV infusions of boserolimab 7 mg and pembrolizumab 200 mg. Boserolimab and pembrolizumab are administered once Q3W on Day 1 of each cycle for a total of up to approximately 35 cycles (up to approximately 2 years). Each cycle is 3 weeks long.
Drug: Boserolimab · Biological: Pembrolizumab
Participants receive separate IV infusions of boserolimab 20 mg and pembrolizumab 200 mg. Boserolimab and pembrolizumab are administered once Q3W on Day 1 of each cycle for a total of up to approximately 35 cycles (up to approximately 2 years). Each cycle is 3 weeks long.
Drug: Boserolimab · Biological: Pembrolizumab
Participants receive separate IV infusions of boserolimab 70 mg and pembrolizumab 200 mg. Boserolimab and pembrolizumab are administered once Q3W on Day 1 of each cycle for a total of up to approximately 35 cycles (up to approximately 2 years). Each cycle is 3 weeks long.
Drug: Boserolimab · Biological: Pembrolizumab
Participants receive separate IV infusions of boserolimab 200 mg and pembrolizumab 200 mg. Boserolimab and pembrolizumab are administered once Q3W on Day 1 of each cycle for a total of up to approximately 35 cycles (up to approximately 2 years). Each cycle is 3 weeks long.
Drug: Boserolimab · Biological: Pembrolizumab
Participants with triple-negative breast cancer (TNBC) receive separate IV infusions of boserolimab 30 mg and pembrolizumab 200 mg. Boserolimab and pembrolizumab are administered once Q3W on Day 1 of each cycle for a total of up to approximately 35 cycles (up to approximately 2 years). Each cycle is 3 weeks long.
Drug: Boserolimab · Biological: Pembrolizumab
Participants with endometrial cancer receive separate IV infusions of boserolimab 30 mg and pembrolizumab 200 mg. Boserolimab and pembrolizumab are administered once Q3W on Day 1 of each cycle for a total of up to approximately 35 cycles (up to approximately 2 years). Each cycle is 3 weeks long.
Drug: Boserolimab · Biological: Pembrolizumab
Participants with endometrial cancer receive separate IV infusions of boserolimab 30 mg and pembrolizumab 400 mg. Boserolimab was administered once every 6 weeks (Q6W) on Day 1 of each cycle for a total of up to approximately 4 cycles (up to approximately 6 months). Pembrolizumab is administered once Q6W on Day 1 of each cycle for a total of up to approximately 18 cycles (up to approximately 27 months). Each cycle is 6 weeks long.
Drug: Boserolimab · Biological: Pembrolizumab
Participants with non-small cell lung cancer (NSCLC) receive separate IV infusions of boserolimab 30 mg, pembrolizumab 200 mg, pemetrexed 500 mg/m\^2, and carboplatin area under the curve (AUC) 5 mg/mL/min. Boserolimab is administered once Q3W on Day 1 of each cycle for a total of up to approximately 8 cycles (up to approximately 6 months). Pembrolizumab and pemetrexed are administered once Q3W on Day 1 of each cycle for a total of up to approximately 35 cycles (up to approximately 2 years). Carboplatin is administered once Q3W on Day 1 of each cycle for a total of up to approximately 4 cycles (up to approximately 3 months). Each cycle is 3 weeks long.
Drug: Boserolimab · Biological: Pembrolizumab · Drug: Pemetrexed · Drug: Carboplatin
Participants with TNBC receive separate IV infusions of boserolimab 30 mg, pembrolizumab 400 mg, and nab-paclitaxel 100 mg/m\^2. Boserolimab and pembrolizumab are administered once Q6W on Day 1 of each cycle for a total of up to approximately 18 cycles (up to approximately 27 months). Nab-paclitaxel is administered on a 3-weeks on/1-week off schedule every 28 days (Days 1, 8, 15, 29, and 36 of odd-numbered cycles and Days 1, 15, 22, and 29 of even-numbered cycles). Each cycle is 6 weeks long
Drug: Boserolimab · Biological: Pembrolizumab · Drug: Nab-paclitaxel
IV infusion
Also known as: MK-5890
IV infusion
Also known as: MK-3475, KEYTRUDA®
IV infusion
Also known as: ALIMTA®
IV infusion
Also known as: PARAPLATIN®
IV infusion
Also known as: ABRAXANE®
Number of Participants Who Experienced a Dose-Limiting Toxicity (DLT)
DLTs were assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events version 5. A DLT was defined as any of the following events: Grade 4 nonhematologic toxicity; Grade 4 hematologic toxicity lasting ≥7 days, except thrombocytopenia; Grade 4 thrombocytopenia; Grade 3 thrombocytopenia requiring a platelet transfusion; Nonhematologic adverse event (AE) Grade ≥3, with exceptions; Grade 3 or 4 nonhematologic laboratory abnormality; Prolonged delay (\>2 weeks) in initiating Cycle 2 due to treatment-related toxicity; Treatment-related toxicity resulting in study drug discontinuation during the DLT evaluation period; Missing \>25% of any study drug during the DLT evaluation period due to a treatment-related AE; or Grade 5 toxicity. The number of participants who experienced one or more DLTs is reported.
Time frame: Up to 21 days in Cycle 1
Number of Participants With One or More AEs
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. The number of participants who experienced one or more AEs is reported.
Time frame: Up to approximately 78 months
Number of Participants Who Discontinued Study Treatment Due to an AE
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. The number of participants who discontinued study treatment due to an AE is reported.
Time frame: Up to 23 months
Area Under the Concentration-Time Curve From Time 0 to Last Quantifiable Concentration (AUC0-last) of Boserolimab
AUC0-last was defined as the area under the concentration versus time curve for boserolimab from 0 to the time of the last quantifiable concentration in serum. Samples were taken predose and at specified times postdose to determine the AUC0-last of boserolimab. PK collection time frames include: Arms 1, 2 (Cycle = 3 weeks): Predose, at start \& end of infusion on Day 1 Cycle 1, Days 2, 3, 5, 8, 15 of Cycle 1, and predose on Day 1 of Cycle 2; Arms 1a, 2a, 2b, 3 (Cycle = 3 weeks): Predose, at start \& end of infusion on Day 1 Cycle 1, Days 2, 3, 8, 15 of Cycle 1, and predose on Day 1 of Cycle 2; Arms 2c and 4 (Cycle = 6 weeks): Predose, at start \& end of infusion on Day 1 Cycle 1, Days 2, 3, 8, 15, 22 of Cycle 1, and predose on Day 1 of Cycle 2.
Time frame: Predose Day 1 Cycle 1 and at designated timepoints up to Day 1 Cycle 2
Area Under the Concentration-Time Curve From Time 0 to 3 Weeks (AUC0-3w) of Boserolimab
AUC0-3w was defined as the area under the concentration versus time curve for boserolimab from 0 to 3 weeks in serum. Samples were taken predose and at specified times postdose to determine the AUC0-3w of boserolimab. PK collection time frames include: Arms 1, 2 (Cycle = 3 weeks): Predose, at start \& end of infusion on Day 1 Cycle 1, Days 2, 3, 5, 8, 15 of Cycle 1, and predose on Day 1 of Cycle 2; Arms 1a, 2a, 2b, 3 (Cycle = 3 weeks): Predose, at start \& end of infusion on Day 1 Cycle 1, Days 2, 3, 8, 15 of Cycle 1, and predose on Day 1 of Cycle 2; Arms 2c and 4 (Cycle = 6 weeks): Predose, at start \& end of infusion on Day 1 Cycle 1, Days 2, 3, 8, 15, 22 of Cycle 1.
Time frame: Predose Day 1 Cycle 1 and at designated timepoints up to Day 1 Cycle 2
Area Under the Concentration-Time Curve From Time 0 to 6 Weeks (AUC0-6w) of Boserolimab
AUC0-6w was defined as the area under the concentration versus time curve for boserolimab from 0 to 6 weeks in serum. Samples were taken predose and at specified times postdose to determine the AUC0-6w of boserolimab. As pre-specified in the protocol, different arms had different sampling schedules and cycle lengths and therefore AUC0-6w was not analyzed for all Arms; AUC0-6w was only analyzed for Arms 2c and 4 which had 6-week cycles.
Time frame: Arms 2c and 4 (Cycle = 6 weeks): Predose, at start & end of infusion on Day 1 Cycle 1, Days 2, 3, 8, 15, 22 of Cycle 1, and predose on Day 1 Cycle 2
Minimum Concentration (Cmin) of Boserolimab
Cmin of boserolimab was defined as the minimum concentration of boserolimab observed in serum. Samples were taken predose and at specified times postdose to determine the Cmin of boserolimab. PK collection time frames include: Arms 1, 2 (Cycle = 3 weeks): Predose, at start \& end of infusion on Day 1 Cycle 1, Days 2, 3, 5, 8, 15 of Cycle 1, and predose on Day 1 of Cycle 2; Arms 1a, 2a, 2b, 3 (Cycle = 3 weeks): Predose, at start \& end of infusion on Day 1 Cycle 1, Days 2, 3, 8, 15 of Cycle 1, and predose on Day 1 of Cycle 2; Arms 2c and 4 (Cycle = 6 weeks): Predose, at start \& end of infusion on Day 1 Cycle 1, Days 2, 3, 8, 15, 22 of Cycle 1, and predose on Day 1 of Cycle 2.
Time frame: Predose Day 1 Cycle 1 and at designated timepoints up to Day 1 Cycle 2
Maximum Concentration (Cmax) of Boserolimab
Cmax of boserolimab was defined as the maximum concentration of boserolimab observed in serum. Samples were taken predose and at specified times postdose to determine the Cmax of boserolimab. PK collection time frames include: Arms 1, 2 (Cycle = 3 weeks): Predose, at start \& end of infusion on Day 1 Cycle 1, Days 2, 3, 5, 8, 15 of Cycle 1, and predose on Day 1 of Cycle 2; Arms 1a, 2a, 2b, 3 (Cycle = 3 weeks): Predose, at start \& end of infusion on Day 1 Cycle 1, Days 2, 3, 8, 15 of Cycle 1, and predose on Day 1 of Cycle 2; Arms 2c and 4 (Cycle = 6 weeks): Predose, at start \& end of infusion on Day 1 Cycle 1, Days 2, 3, 8, 15, 22 of Cycle 1, and predose on Day 1 of Cycle 2.
Time frame: Predose Day 1 Cycle 1 and at designated timepoints up to Day 1 Cycle 2
Objective Response Rate (ORR) as Assessed by Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1)
ORR was defined as the percentage of participants who had a Complete Response (CR: disappearance of all target lesions) or a Partial Response (PR: at least a 30% decrease in the sum of diameters of target lesions) as assessed using RECIST 1.1. As pre-specified in the protocol, ORR was analyzed for participants treated with boserolimab when used as monotherapy in Arm 1a, in combination with pembrolizumab in Switch-over Arm 1a and Arms 2a, 2b, and 2c, or in combination with pembrolizumab + nab-paclitaxel in Arm 4. Per protocol, ORR was not analyzed in Arms 1, 2, or 3. The percentage of participants who experienced a CR or PR, as assessed by the investigator, is reported.
Time frame: Up to approximately 78 months
Arm 3: Number of Participants Who Experienced a DLT
DLTs were assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events version 5. A DLT was defined as any of the following events: Grade 4 nonhematologic toxicity; Grade 4 hematologic toxicity lasting ≥7 days, except thrombocytopenia; Grade 4 thrombocytopenia; Grade 3 thrombocytopenia requiring a platelet transfusion; Nonhematologic adverse event (AE) Grade ≥3, with exceptions; Grade 3 or 4 nonhematologic laboratory abnormality; Prolonged delay (\>2 weeks) in initiating Cycle 2 due to treatment-related toxicity; Treatment-related toxicity resulting in study drug discontinuation during the DLT evaluation period; Missing \>25% of any study drug during the DLT evaluation period due to a treatment-related AE; or Grade 5 toxicity. The number of participants who experienced one or more DLTs in Arm 3 is reported
Time frame: Up to 21 days in Cycle 1
Arm 4: Number of Participants Who Experienced a DLT
DLTs were assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events version 5. A DLT was defined as any of the following events: Grade 4 nonhematologic toxicity; Grade 4 hematologic toxicity lasting ≥7 days, except thrombocytopenia; Grade 4 thrombocytopenia; Grade 3 thrombocytopenia requiring a platelet transfusion; Nonhematologic adverse event (AE) Grade ≥3, with exceptions; Grade 3 or 4 nonhematologic laboratory abnormality; Prolonged delay (\>2 weeks) in initiating Cycle 2 due to treatment-related toxicity; Treatment-related toxicity resulting in study drug discontinuation during the DLT evaluation period; Missing \>25% of any study drug during the DLT evaluation period due to a treatment-related AE; or Grade 5 toxicity. The number of participants who experienced one or more DLTs in Arm 4 is reported.
Time frame: Up to 28 days in Cycle 1
Arm 3 and 4: Number of Participants With One or More AEs
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. The number of participants in Arms 3 and 4 who experienced one or more AEs is reported.
Time frame: Up to 57 months
Arm 3 and 4: Number of Participants Who Discontinued Study Treatment Due to an AE
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. The number of participants in Arms 3 or 4 who discontinued study treatment due to an AE is reported.
Time frame: Up to 27 months
| Milestone | Arm 1 Boserolimab 2 mg Q3W | Arm 1 Boserolimab 7 mg Q3W | Arm 1 Boserolimab 20 mg Q3W | Arm 1 Boserolimab 70 mg Q3W | Arm 1 Boserolimab 200 mg Q3W | Arm 1 Boserolimab 700 mg Q3W | Arm 1a Boserolimab 30 mg Q3W (Endometrial) | Arm 2 Boserolimab 2 mg Q3W + Pembrolizumab 200 mg Q3W | Arm 2 Boserolimab 7 mg Q3W + Pembrolizumab 200 mg Q3W | Arm 2 Boserolimab 20 mg Q3W + Pembrolizumab 200 mg Q3W | Arm 2 Boserolimab 70 mg Q3W + Pembrolizumab 200 mg Q3W | Arm 2 Boserolimab 200 mg Q3W + Pembrolizumab 200 mg Q3W | Arm 2a Boserolimab 30 mg Q3W + Pembrolizumab 200 mg Q3W (TNBC) | Arm 2b Boserolimab 30 mg Q3W + Pembrolizumab 200 mg Q3W (Endometrial) | Arm 2c Boserolimab 30 mg Q6W + Pembrolizumab 400 mg Q6W (Endometrial) | Arm 3 Boserolimab 30 mg Q3W + Pembrolizumab 200 mg Q3W + Pemetrexed + Carboplatin (NSCLC) | Arm 4 Boserolimab 30 mg Q6W + Pembrolizumab 400 mg Q6W + Nab-paclitaxel (TNBC) | Switch-over Arm 1 Boserolimab 2 mg Q3W To Boserolimab 2 mg + Pembrolizumab 200 mg Q3W | Switch-over Arm 1 Boserolimab 7 mg Q3W To Boserolimab 2 mg + Pembrolizumab 200 mg Q3W | Switch-over Arm 1 Boserolimab 20 mg Q3W To Boserolimab 7 mg + Pembrolizumab 200 mg Q3W | Switch-over Arm 1 Boserolimab 20 mg Q3W To Boserolimab 20 mg + Pembrolizumab 200 mg Q3W | Switch-over Arm 1 Boserolimab 70 mg Q3W To Boserolimab 20 mg + Pembrolizumab 200 mg Q3W | Switch-over Arm 1 Boserolimab 200 mg Q3W To Boserolimab 20 mg + Pembrolizumab 200 mg Q3W | Switch-over Arm 1 Boserolimab 200 mg Q3W To Boserolimab 70 mg + Pembrolizumab 200 mg Q3W | Switch-over Arm 1 Boserolimab 200 mg Q3W To Boserolimab 200 mg + Pembrolizumab 200 mg Q3W | Switch-over Arm 1a Boserolimab 30mg Q3W (Endometrial) To Boserolimab 30mg + Pembrolizumab 200mg Q3W |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Started | 3 | 3 | 6 | 3 | 9 | 2 | 14 | 3 | 3 | 4 | 7 | 14 | 31 | 15 | 14 | 10 | 41 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Treated | 3 | 3 | 6 | 3 | 8 | 2 | 14 | 3 | 3 | 3 | 7 | 14 | 30 | 15 | 13 | 10 | 41 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Completed | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 2 | 1 | 1 | 1 | 2 | 22 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Not completed | 3 | 3 | 6 | 3 | 9 | 2 | 14 | 3 | 3 | 4 | 7 | 12 | 30 | 14 | 13 | 8 | 19 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Withdrew: Death | 2 | 2 | 1 | 1 | 3 | 2 | 5 | 3 | 3 | 3 | 7 | 12 | 28 | 14 | 10 | 8 | 18 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Withdrew: Lost to follow-up | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 0 | 1 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Withdrew: Physician decision | 0 | 0 | 0 | 0 | 1 | 0 | 0 | 0 | 0 | 1 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Withdrew: Randomized by mistake without study treatment | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 0 | 1 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Withdrew: Progressive disease, switched over to boserolimab + pembrolizumab combination treatment | 1 | 1 | 5 | 2 | 5 | 0 | 9 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Withdrew: Withdrawal by subject | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 0 | 1 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Milestone | Arm 1 Boserolimab 2 mg Q3W | Arm 1 Boserolimab 7 mg Q3W | Arm 1 Boserolimab 20 mg Q3W | Arm 1 Boserolimab 70 mg Q3W | Arm 1 Boserolimab 200 mg Q3W | Arm 1 Boserolimab 700 mg Q3W | Arm 1a Boserolimab 30 mg Q3W (Endometrial) | Arm 2 Boserolimab 2 mg Q3W + Pembrolizumab 200 mg Q3W | Arm 2 Boserolimab 7 mg Q3W + Pembrolizumab 200 mg Q3W | Arm 2 Boserolimab 20 mg Q3W + Pembrolizumab 200 mg Q3W | Arm 2 Boserolimab 70 mg Q3W + Pembrolizumab 200 mg Q3W | Arm 2 Boserolimab 200 mg Q3W + Pembrolizumab 200 mg Q3W | Arm 2a Boserolimab 30 mg Q3W + Pembrolizumab 200 mg Q3W (TNBC) | Arm 2b Boserolimab 30 mg Q3W + Pembrolizumab 200 mg Q3W (Endometrial) | Arm 2c Boserolimab 30 mg Q6W + Pembrolizumab 400 mg Q6W (Endometrial) | Arm 3 Boserolimab 30 mg Q3W + Pembrolizumab 200 mg Q3W + Pemetrexed + Carboplatin (NSCLC) | Arm 4 Boserolimab 30 mg Q6W + Pembrolizumab 400 mg Q6W + Nab-paclitaxel (TNBC) | Switch-over Arm 1 Boserolimab 2 mg Q3W To Boserolimab 2 mg + Pembrolizumab 200 mg Q3W | Switch-over Arm 1 Boserolimab 7 mg Q3W To Boserolimab 2 mg + Pembrolizumab 200 mg Q3W | Switch-over Arm 1 Boserolimab 20 mg Q3W To Boserolimab 7 mg + Pembrolizumab 200 mg Q3W | Switch-over Arm 1 Boserolimab 20 mg Q3W To Boserolimab 20 mg + Pembrolizumab 200 mg Q3W | Switch-over Arm 1 Boserolimab 70 mg Q3W To Boserolimab 20 mg + Pembrolizumab 200 mg Q3W | Switch-over Arm 1 Boserolimab 200 mg Q3W To Boserolimab 20 mg + Pembrolizumab 200 mg Q3W | Switch-over Arm 1 Boserolimab 200 mg Q3W To Boserolimab 70 mg + Pembrolizumab 200 mg Q3W | Switch-over Arm 1 Boserolimab 200 mg Q3W To Boserolimab 200 mg + Pembrolizumab 200 mg Q3W | Switch-over Arm 1a Boserolimab 30mg Q3W (Endometrial) To Boserolimab 30mg + Pembrolizumab 200mg Q3W |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Started | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 1 | 2 | 3 | 2 | 2 | 2 | 1 | 9 |
| Treated | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 1 | 2 | 3 | 2 | 2 | 2 | 1 | 9 |
| Completed | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 0 | 0 | 1 | 1 | 0 | 1 | 0 | 3 |
| Not completed | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 2 | 2 | 1 | 2 | 1 | 1 | 6 |
| Withdrew: Death | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 2 | 2 | 1 | 2 | 0 | 1 | 6 |
| Withdrew: Lost to follow-up | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 0 | 0 |
AUC0-last was defined as the area under the concentration versus time curve for boserolimab from 0 to the time of the last quantifiable concentration in serum. Samples were taken predose and at specified times postdose to determine the AUC0-last of boserolimab. PK collection time frames include: Arms 1, 2 (Cycle = 3 weeks): Predose, at start \& end of infusion on Day 1 Cycle 1, Days 2, 3, 5, 8, 15 of Cycle 1, and predose on Day 1 of Cycle 2; Arms 1a, 2a, 2b, 3 (Cycle = 3 weeks): Predose, at start \& end of infusion on Day 1 Cycle 1, Days 2, 3, 8, 15 of Cycle 1, and predose on Day 1 of Cycle 2; Arms 2c and 4 (Cycle = 6 weeks): Predose, at start \& end of infusion on Day 1 Cycle 1, Days 2, 3, 8, 15, 22 of Cycle 1, and predose on Day 1 of Cycle 2.
| day*μg/mL | Arm 1 Boserolimab 2 mg Q3W | Arm 1 Boserolimab 7 mg Q3W | Arm 1 Boserolimab 20 mg Q3W | Arm 1 Boserolimab 70 mg Q3W | Arm 1 Boserolimab 200 mg Q3W | Arm 1 Boserolimab 700 mg Q3W | Arm 1a Boserolimab 30 mg Q3W (Endometrial) | Arm 2 Boserolimab 2 mg Q3W + Pembrolizumab 200 mg Q3W | Arm 2 Boserolimab 7 mg Q3W + Pembrolizumab 200 mg Q3W | Arm 2 Boserolimab 20 mg Q3W + Pembrolizumab 200 mg Q3W | Arm 2 Boserolimab 70 mg Q3W + Pembrolizumab 200 mg Q3W | Arm 2 Boserolimab 200 mg Q3W + Pembrolizumab 200 mg Q3W | Arm 2a Boserolimab 30 mg Q3W + Pembrolizumab 200 mg Q3W (TNBC) | Arm 2b Boserolimab 30 mg Q3W + Pembrolizumab 200 mg Q3W (Endometrial) | Arm 2c Boserolimab 30 mg Q6W + Pembrolizumab 400 mg Q6W (Endometrial) | Arm 3 Boserolimab 30 mg Q3W + Pembrolizumab 200 mg Q3W + Pemetrexed + Carboplatin (NSCLC) | Arm 4 Boserolimab 30 mg Q6W + Pembrolizumab 400 mg Q6W + Nab-paclitaxel (TNBC) |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Area Under the Concentration-Time Curve From Time 0 to Last Quantifiable Concentration (AUC0-last) of Boserolimab | 0.761 ± 179 | 7.61 ± NA | 44.4 ± 28.6 | 150 ± 14.2 | 469 ± 42.9 | 918 ± 21.4 | 44.4 ± 51.7 | 0.816 ± 20.8 | 3.9 ± 117 | 26.1 ± 38.5 | 84.5 ± 192 | 646 ± 16.3 | 41.5 ± 109 | 44.9 ± 68.6 | 47.5 ± 58.5 | 41.6 ± 44.5 | 62.9 ± 57.8 |
DLTs were assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events version 5. A DLT was defined as any of the following events: Grade 4 nonhematologic toxicity; Grade 4 hematologic toxicity lasting ≥7 days, except thrombocytopenia; Grade 4 thrombocytopenia; Grade 3 thrombocytopenia requiring a platelet transfusion; Nonhematologic adverse event (AE) Grade ≥3, with exceptions; Grade 3 or 4 nonhematologic laboratory abnormality; Prolonged delay (\>2 weeks) in initiating Cycle 2 due to treatment-related toxicity; Treatment-related toxicity resulting in study drug discontinuation during the DLT evaluation period; Missing \>25% of any study drug during the DLT evaluation period due to a treatment-related AE; or Grade 5 toxicity. The number of participants who experienced one or more DLTs is reported.
| Participants | Arm 1 Boserolimab 2 mg Q3W | Arm 1 Boserolimab 7 mg Q3W | Arm 1 Boserolimab 20 mg Q3W | Arm 1 Boserolimab 70 mg Q3W | Arm 1 Boserolimab 200 mg Q3W | Arm 1 Boserolimab 700 mg Q3W | Arm 1a Boserolimab 30 mg Q3W (Endometrial) | Arm 2 Boserolimab 2 mg Q3W + Pembrolizumab 200 mg Q3W | Arm 2 Boserolimab 7 mg Q3W + Pembrolizumab 200 mg Q3W | Arm 2 Boserolimab 20 mg Q3W + Pembrolizumab 200 mg Q3W | Arm 2 Boserolimab 70 mg Q3W + Pembrolizumab 200 mg Q3W | Arm 2 Boserolimab 200 mg Q3W + Pembrolizumab 200 mg Q3W | Arm 2a Boserolimab 30 mg Q3W + Pembrolizumab 200 mg Q3W (TNBC) | Arm 2b Boserolimab 30 mg Q3W + Pembrolizumab 200 mg Q3W (Endometrial) | Arm 2c Boserolimab 30 mg Q6W + Pembrolizumab 400 mg Q6W (Endometrial) | Switch-over Arm 1 Boserolimab 2 mg Q3W To Boserolimab 2 mg + Pembrolizumab 200 mg Q3W | Switch-over Arm 1 Boserolimab 7 mg Q3W To Boserolimab 2 mg + Pembrolizumab 200 mg Q3W | Switch-over Arm 1 Boserolimab 20 mg Q3W To Boserolimab 7 mg + Pembrolizumab 200 mg Q3W | Switch-over Arm 1 Boserolimab 20 mg Q3W To Boserolimab 20 mg + Pembrolizumab 200 mg Q3W | Switch-over Arm 1 Boserolimab 70 mg Q3W To Boserolimab 20 mg + Pembrolizumab 200 mg Q3W | Switch-over Arm 1 Boserolimab 200 mg Q3W To Boserolimab 20 mg + Pembrolizumab 200 mg Q3W | Switch-over Arm 1 Boserolimab 200 mg Q3W To Boserolimab 70 mg + Pembrolizumab 200 mg Q3W | Switch-over Arm 1 Boserolimab 200 mg Q3W To Boserolimab 200 mg + Pembrolizumab 200 mg Q3W | Switch-over Arm 1a Boserolimab 30mg Q3W (Endometrial) To Boserolimab 30mg + Pembrolizumab 200mg Q3W |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Number of Participants Who Experienced a Dose-Limiting Toxicity (DLT) | 0 | 0 | 1 | 0 | 0 | 2 | 0 | 0 | 0 | 0 | 1 | 0 | 0 | 0 | 1 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 |
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. The number of participants who experienced one or more AEs is reported.
| Participants | Arm 1 Boserolimab 2 mg Q3W | Arm 1 Boserolimab 7 mg Q3W | Arm 1 Boserolimab 20 mg Q3W | Arm 1 Boserolimab 70 mg Q3W | Arm 1 Boserolimab 200 mg Q3W | Arm 1 Boserolimab 700 mg Q3W | Arm 1a Boserolimab 30 mg Q3W (Endometrial) | Arm 2 Boserolimab 2 mg Q3W + Pembrolizumab 200 mg Q3W | Arm 2 Boserolimab 7 mg Q3W + Pembrolizumab 200 mg Q3W | Arm 2 Boserolimab 20 mg Q3W + Pembrolizumab 200 mg Q3W | Arm 2 Boserolimab 70 mg Q3W + Pembrolizumab 200 mg Q3W | Arm 2 Boserolimab 200 mg Q3W + Pembrolizumab 200 mg Q3W | Arm 2a Boserolimab 30 mg Q3W + Pembrolizumab 200 mg Q3W (TNBC) | Arm 2b Boserolimab 30 mg Q3W + Pembrolizumab 200 mg Q3W (Endometrial) | Arm 2c Boserolimab 30 mg Q6W + Pembrolizumab 400 mg Q6W (Endometrial) | Switch-over Arm 1 Boserolimab 2 mg Q3W To Boserolimab 2 mg + Pembrolizumab 200 mg Q3W | Switch-over Arm 1 Boserolimab 7 mg Q3W To Boserolimab 2 mg + Pembrolizumab 200 mg Q3W | Switch-over Arm 1 Boserolimab 20 mg Q3W To Boserolimab 7 mg + Pembrolizumab 200 mg Q3W | Switch-over Arm 1 Boserolimab 20 mg Q3W To Boserolimab 20 mg + Pembrolizumab 200 mg Q3W | Switch-over Arm 1 Boserolimab 70 mg Q3W To Boserolimab 20 mg + Pembrolizumab 200 mg Q3W | Switch-over Arm 1 Boserolimab 200 mg Q3W To Boserolimab 20 mg + Pembrolizumab 200 mg Q3W | Switch-over Arm 1 Boserolimab 200 mg Q3W To Boserolimab 70 mg + Pembrolizumab 200 mg Q3W | Switch-over Arm 1 Boserolimab 200 mg Q3W To Boserolimab 200 mg + Pembrolizumab 200 mg Q3W | Switch-over Arm 1a Boserolimab 30mg Q3W (Endometrial) To Boserolimab 30mg + Pembrolizumab 200mg Q3W |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Number of Participants With One or More AEs | 3 | 3 | 6 | 3 | 8 | 2 | 14 | 3 | 3 | 3 | 7 | 14 | 30 | 15 | 13 | 1 | 1 | 2 | 3 | 2 | 2 | 2 | 1 | 8 |
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. The number of participants who discontinued study treatment due to an AE is reported.
| Participants | Arm 1 Boserolimab 2 mg Q3W | Arm 1 Boserolimab 7 mg Q3W | Arm 1 Boserolimab 20 mg Q3W | Arm 1 Boserolimab 70 mg Q3W | Arm 1 Boserolimab 200 mg Q3W | Arm 1 Boserolimab 700 mg Q3W | Arm 1a Boserolimab 30 mg Q3W (Endometrial) | Arm 2 Boserolimab 2 mg Q3W + Pembrolizumab 200 mg Q3W | Arm 2 Boserolimab 7 mg Q3W + Pembrolizumab 200 mg Q3W | Arm 2 Boserolimab 20 mg Q3W + Pembrolizumab 200 mg Q3W | Arm 2 Boserolimab 70 mg Q3W + Pembrolizumab 200 mg Q3W | Arm 2 Boserolimab 200 mg Q3W + Pembrolizumab 200 mg Q3W | Arm 2a Boserolimab 30 mg Q3W + Pembrolizumab 200 mg Q3W (TNBC) | Arm 2b Boserolimab 30 mg Q3W + Pembrolizumab 200 mg Q3W (Endometrial) | Arm 2c Boserolimab 30 mg Q6W + Pembrolizumab 400 mg Q6W (Endometrial) | Switch-over Arm 1 Boserolimab 2 mg Q3W To Boserolimab 2 mg + Pembrolizumab 200 mg Q3W | Switch-over Arm 1 Boserolimab 7 mg Q3W To Boserolimab 2 mg + Pembrolizumab 200 mg Q3W | Switch-over Arm 1 Boserolimab 20 mg Q3W To Boserolimab 7 mg + Pembrolizumab 200 mg Q3W | Switch-over Arm 1 Boserolimab 20 mg Q3W To Boserolimab 20 mg + Pembrolizumab 200 mg Q3W | Switch-over Arm 1 Boserolimab 70 mg Q3W To Boserolimab 20 mg + Pembrolizumab 200 mg Q3W | Switch-over Arm 1 Boserolimab 200 mg Q3W To Boserolimab 20 mg + Pembrolizumab 200 mg Q3W | Switch-over Arm 1 Boserolimab 200 mg Q3W To Boserolimab 70 mg + Pembrolizumab 200 mg Q3W | Switch-over Arm 1 Boserolimab 200 mg Q3W To Boserolimab 200 mg + Pembrolizumab 200 mg Q3W | Switch-over Arm 1a Boserolimab 30mg Q3W (Endometrial) To Boserolimab 30mg + Pembrolizumab 200mg Q3W |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Number of Participants Who Discontinued Study Treatment Due to an AE | 0 | 0 | 0 | 0 | 0 | 2 | 0 | 0 | 1 | 0 | 1 | 1 | 4 | 1 | 2 | 0 | 0 | 0 | 1 | 0 | 0 | 0 | 0 | 2 |
AUC0-3w was defined as the area under the concentration versus time curve for boserolimab from 0 to 3 weeks in serum. Samples were taken predose and at specified times postdose to determine the AUC0-3w of boserolimab. PK collection time frames include: Arms 1, 2 (Cycle = 3 weeks): Predose, at start \& end of infusion on Day 1 Cycle 1, Days 2, 3, 5, 8, 15 of Cycle 1, and predose on Day 1 of Cycle 2; Arms 1a, 2a, 2b, 3 (Cycle = 3 weeks): Predose, at start \& end of infusion on Day 1 Cycle 1, Days 2, 3, 8, 15 of Cycle 1, and predose on Day 1 of Cycle 2; Arms 2c and 4 (Cycle = 6 weeks): Predose, at start \& end of infusion on Day 1 Cycle 1, Days 2, 3, 8, 15, 22 of Cycle 1.
| day*μg/mL | Arm 1 Boserolimab 2 mg Q3W | Arm 1 Boserolimab 7 mg Q3W | Arm 1 Boserolimab 20 mg Q3W | Arm 1 Boserolimab 70 mg Q3W | Arm 1 Boserolimab 200 mg Q3W | Arm 1 Boserolimab 700 mg Q3W | Arm 1a Boserolimab 30 mg Q3W (Endometrial) | Arm 2 Boserolimab 2 mg Q3W + Pembrolizumab 200 mg Q3W | Arm 2 Boserolimab 7 mg Q3W + Pembrolizumab 200 mg Q3W | Arm 2 Boserolimab 20 mg Q3W + Pembrolizumab 200 mg Q3W | Arm 2 Boserolimab 70 mg Q3W + Pembrolizumab 200 mg Q3W | Arm 2 Boserolimab 200 mg Q3W + Pembrolizumab 200 mg Q3W | Arm 2a Boserolimab 30 mg Q3W + Pembrolizumab 200 mg Q3W (TNBC) | Arm 2b Boserolimab 30 mg Q3W + Pembrolizumab 200 mg Q3W (Endometrial) | Arm 2c Boserolimab 30 mg Q6W + Pembrolizumab 400 mg Q6W (Endometrial) | Arm 3 Boserolimab 30 mg Q3W + Pembrolizumab 200 mg Q3W + Pemetrexed + Carboplatin (NSCLC) | Arm 4 Boserolimab 30 mg Q6W + Pembrolizumab 400 mg Q6W + Nab-paclitaxel (TNBC) |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Area Under the Concentration-Time Curve From Time 0 to 3 Weeks (AUC0-3w) of Boserolimab | 1.79 ± 111 | 7.77 ± NA | 44.4 ± 28.6 | 155 ± 7.85 | 531 ± 28.1 | 1060 ± 0.434 | 44.3 ± 54 | 1.2 ± 22 | 6.69 ± 47.5 | 28.1 ± 50.8 | 142 ± 63.3 | 661 ± 16.4 | 49.9 ± 41.3 | 50.5 ± 34.2 | 48.1 ± 42.5 | 42.2 ± 41.5 | 60.4 ± 39.5 |
AUC0-6w was defined as the area under the concentration versus time curve for boserolimab from 0 to 6 weeks in serum. Samples were taken predose and at specified times postdose to determine the AUC0-6w of boserolimab. As pre-specified in the protocol, different arms had different sampling schedules and cycle lengths and therefore AUC0-6w was not analyzed for all Arms; AUC0-6w was only analyzed for Arms 2c and 4 which had 6-week cycles.
| day*μg/mL | Arm 2c Boserolimab 30 mg Q6W + Pembrolizumab 400 mg Q6W (Endometrial) | Arm 4 Boserolimab 30 mg Q6W + Pembrolizumab 400 mg Q6W + Nab-paclitaxel (TNBC) |
|---|---|---|
| Area Under the Concentration-Time Curve From Time 0 to 6 Weeks (AUC0-6w) of Boserolimab | 55 ± 49.2 | 68.3 ± 45.4 |
Cmin of boserolimab was defined as the minimum concentration of boserolimab observed in serum. Samples were taken predose and at specified times postdose to determine the Cmin of boserolimab. PK collection time frames include: Arms 1, 2 (Cycle = 3 weeks): Predose, at start \& end of infusion on Day 1 Cycle 1, Days 2, 3, 5, 8, 15 of Cycle 1, and predose on Day 1 of Cycle 2; Arms 1a, 2a, 2b, 3 (Cycle = 3 weeks): Predose, at start \& end of infusion on Day 1 Cycle 1, Days 2, 3, 8, 15 of Cycle 1, and predose on Day 1 of Cycle 2; Arms 2c and 4 (Cycle = 6 weeks): Predose, at start \& end of infusion on Day 1 Cycle 1, Days 2, 3, 8, 15, 22 of Cycle 1, and predose on Day 1 of Cycle 2.
| μg/mL | Arm 1 Boserolimab 2 mg Q3W | Arm 1 Boserolimab 7 mg Q3W | Arm 1 Boserolimab 20 mg Q3W | Arm 1 Boserolimab 70 mg Q3W | Arm 1 Boserolimab 200 mg Q3W | Arm 1 Boserolimab 700 mg Q3W | Arm 1a Boserolimab 30 mg Q3W (Endometrial) | Arm 2 Boserolimab 2 mg Q3W + Pembrolizumab 200 mg Q3W | Arm 2 Boserolimab 7 mg Q3W + Pembrolizumab 200 mg Q3W | Arm 2 Boserolimab 20 mg Q3W + Pembrolizumab 200 mg Q3W | Arm 2 Boserolimab 70 mg Q3W + Pembrolizumab 200 mg Q3W | Arm 2 Boserolimab 200 mg Q3W + Pembrolizumab 200 mg Q3W | Arm 2a Boserolimab 30 mg Q3W + Pembrolizumab 200 mg Q3W (TNBC) | Arm 2b Boserolimab 30 mg Q3W + Pembrolizumab 200 mg Q3W (Endometrial) | Arm 2c Boserolimab 30 mg Q6W + Pembrolizumab 400 mg Q6W (Endometrial) | Arm 3 Boserolimab 30 mg Q3W + Pembrolizumab 200 mg Q3W + Pemetrexed + Carboplatin (NSCLC) | Arm 4 Boserolimab 30 mg Q6W + Pembrolizumab 400 mg Q6W + Nab-paclitaxel (TNBC) |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Minimum Concentration (Cmin) of Boserolimab | NA ± NA | 0.0689 ± 0.0975 | 0.421 ± 0.103 | 3.55 ± 0.573 | 15.5 ± 8.08 | 24.3 ± NA | 0.617 ± 0.498 | NA ± NA | 0.0283 ± 0.0400 | 0.0629 ± 0.0575 | 3.55 ± 3.37 | 16.2 ± 5.14 | 0.721 ± 0.505 | 0.610 ± 0.499 | 0.126 ± 0.258 | 0.471 ± 0.473 | 0.158 ± 0.340 |
Cmax of boserolimab was defined as the maximum concentration of boserolimab observed in serum. Samples were taken predose and at specified times postdose to determine the Cmax of boserolimab. PK collection time frames include: Arms 1, 2 (Cycle = 3 weeks): Predose, at start \& end of infusion on Day 1 Cycle 1, Days 2, 3, 5, 8, 15 of Cycle 1, and predose on Day 1 of Cycle 2; Arms 1a, 2a, 2b, 3 (Cycle = 3 weeks): Predose, at start \& end of infusion on Day 1 Cycle 1, Days 2, 3, 8, 15 of Cycle 1, and predose on Day 1 of Cycle 2; Arms 2c and 4 (Cycle = 6 weeks): Predose, at start \& end of infusion on Day 1 Cycle 1, Days 2, 3, 8, 15, 22 of Cycle 1, and predose on Day 1 of Cycle 2.
| μg/mL | Arm 1 Boserolimab 2 mg Q3W | Arm 1 Boserolimab 7 mg Q3W | Arm 1 Boserolimab 20 mg Q3W | Arm 1 Boserolimab 70 mg Q3W | Arm 1 Boserolimab 200 mg Q3W | Arm 1 Boserolimab 700 mg Q3W | Arm 1a Boserolimab 30 mg Q3W (Endometrial) | Arm 2 Boserolimab 2 mg Q3W + Pembrolizumab 200 mg Q3W | Arm 2 Boserolimab 7 mg Q3W + Pembrolizumab 200 mg Q3W | Arm 2 Boserolimab 20 mg Q3W + Pembrolizumab 200 mg Q3W | Arm 2 Boserolimab 70 mg Q3W + Pembrolizumab 200 mg Q3W | Arm 2 Boserolimab 200 mg Q3W + Pembrolizumab 200 mg Q3W | Arm 2a Boserolimab 30 mg Q3W + Pembrolizumab 200 mg Q3W (TNBC) | Arm 2b Boserolimab 30 mg Q3W + Pembrolizumab 200 mg Q3W (Endometrial) | Arm 2c Boserolimab 30 mg Q6W + Pembrolizumab 400 mg Q6W (Endometrial) | Arm 3 Boserolimab 30 mg Q3W + Pembrolizumab 200 mg Q3W + Pemetrexed + Carboplatin (NSCLC) | Arm 4 Boserolimab 30 mg Q6W + Pembrolizumab 400 mg Q6W + Nab-paclitaxel (TNBC) |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Maximum Concentration (Cmax) of Boserolimab | 1.15 ± 175 | 3.32 ± NA | 8.16 ± 28.6 | 21.6 ± 22 | 67.8 ± 23.1 | 105 ± 8.71 | 7.24 ± 46.7 | 0.656 ± 5.08 | 1.75 ± 5.75 | 4.9 ± 39 | 26.9 ± 37 | 83.2 ± 16.6 | 7.89 ± 70.2 | 8.68 ± 24.6 | 8.27 ± 37.4 | 7.44 ± 37.3 | 9.39 ± 33.2 |
ORR was defined as the percentage of participants who had a Complete Response (CR: disappearance of all target lesions) or a Partial Response (PR: at least a 30% decrease in the sum of diameters of target lesions) as assessed using RECIST 1.1. As pre-specified in the protocol, ORR was analyzed for participants treated with boserolimab when used as monotherapy in Arm 1a, in combination with pembrolizumab in Switch-over Arm 1a and Arms 2a, 2b, and 2c, or in combination with pembrolizumab + nab-paclitaxel in Arm 4. Per protocol, ORR was not analyzed in Arms 1, 2, or 3. The percentage of participants who experienced a CR or PR, as assessed by the investigator, is reported.
| Percentage of Participants | Arm 1a Boserolimab 30 mg Q3W (Endometrial) | Arm 2a Boserolimab 30 mg Q3W + Pembrolizumab 200 mg Q3W (TNBC) | Arm 2b Boserolimab 30 mg Q3W + Pembrolizumab 200 mg Q3W (Endometrial) | Arm 2c Boserolimab 30 mg Q6W + Pembrolizumab 400 mg Q6W (Endometrial) | Arm 4 Boserolimab 30 mg Q6W + Pembrolizumab 400 mg Q6W + Nab-paclitaxel (TNBC) | Switch-over Arm 1a Boserolimab 30mg Q3W (Endometrial) To Boserolimab 30mg + Pembrolizumab 200mg Q3W |
|---|---|---|---|---|---|---|
| Objective Response Rate (ORR) as Assessed by Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) | 7.1 (0.2 to 33.9) | 20.0 (7.7 to 38.6) | 13.3 (1.7 to 40.5) | 0.0 (0.0 to 24.7) | 53.7 (37.4 to 69.3) | 11.1 (0.3 to 48.2) |
DLTs were assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events version 5. A DLT was defined as any of the following events: Grade 4 nonhematologic toxicity; Grade 4 hematologic toxicity lasting ≥7 days, except thrombocytopenia; Grade 4 thrombocytopenia; Grade 3 thrombocytopenia requiring a platelet transfusion; Nonhematologic adverse event (AE) Grade ≥3, with exceptions; Grade 3 or 4 nonhematologic laboratory abnormality; Prolonged delay (\>2 weeks) in initiating Cycle 2 due to treatment-related toxicity; Treatment-related toxicity resulting in study drug discontinuation during the DLT evaluation period; Missing \>25% of any study drug during the DLT evaluation period due to a treatment-related AE; or Grade 5 toxicity. The number of participants who experienced one or more DLTs in Arm 3 is reported
| Participants | Arm 3 Boserolimab 30 mg Q3W + Pembrolizumab 200 mg Q3W + Pemetrexed + Carboplatin (NSCLC) |
|---|---|
| Arm 3: Number of Participants Who Experienced a DLT | 0 |
DLTs were assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events version 5. A DLT was defined as any of the following events: Grade 4 nonhematologic toxicity; Grade 4 hematologic toxicity lasting ≥7 days, except thrombocytopenia; Grade 4 thrombocytopenia; Grade 3 thrombocytopenia requiring a platelet transfusion; Nonhematologic adverse event (AE) Grade ≥3, with exceptions; Grade 3 or 4 nonhematologic laboratory abnormality; Prolonged delay (\>2 weeks) in initiating Cycle 2 due to treatment-related toxicity; Treatment-related toxicity resulting in study drug discontinuation during the DLT evaluation period; Missing \>25% of any study drug during the DLT evaluation period due to a treatment-related AE; or Grade 5 toxicity. The number of participants who experienced one or more DLTs in Arm 4 is reported.
| Participants | Arm 4 Boserolimab 30 mg Q6W + Pembrolizumab 400 mg Q6W + Nab-paclitaxel (TNBC) |
|---|---|
| Arm 4: Number of Participants Who Experienced a DLT | 1 |
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. The number of participants in Arms 3 and 4 who experienced one or more AEs is reported.
| Participants | Arm 3 Boserolimab 30 mg Q3W + Pembrolizumab 200 mg Q3W + Pemetrexed + Carboplatin (NSCLC) | Arm 4 Boserolimab 30 mg Q6W + Pembrolizumab 400 mg Q6W + Nab-paclitaxel (TNBC) |
|---|---|---|
| Arm 3 and 4: Number of Participants With One or More AEs | 10 | 41 |
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. The number of participants in Arms 3 or 4 who discontinued study treatment due to an AE is reported.
| Participants | Arm 3 Boserolimab 30 mg Q3W + Pembrolizumab 200 mg Q3W + Pemetrexed + Carboplatin (NSCLC) | Arm 4 Boserolimab 30 mg Q6W + Pembrolizumab 400 mg Q6W + Nab-paclitaxel (TNBC) |
|---|---|---|
| Arm 3 and 4: Number of Participants Who Discontinued Study Treatment Due to an AE | 2 | 6 |
Collected over Up to approximately 78 months. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Arm 1 Boserolimab 2 mg Q3W | 2/3 (66.7%) | 1/3 (33.3%) | 3/3 (100%) |
| Arm 1 Boserolimab 7 mg Q3W | 2/3 (66.7%) | 0/3 (0%) | 3/3 (100%) |
| Arm 1 Boserolimab 20 mg Q3W | 1/6 (16.7%) | 0/6 (0%) | 6/6 (100%) |
| Arm 1 Boserolimab 70 mg Q3W | 1/3 (33.3%) | 0/3 (0%) | 3/3 (100%) |
| Arm 1 Boserolimab 200 mg Q3W | 3/9 (33.3%) | 1/8 (12.5%) | 8/8 (100%) |
| Arm 1 Boserolimab 700 mg Q3W | 2/2 (100%) | 1/2 (50%) | 2/2 (100%) |
| Arm 1a Boserolimab 30 mg Q3W (Endometrial) | 5/14 (35.7%) | 2/14 (14.3%) | 14/14 (100%) |
| Arm 2 Boserolimab 2 mg Q3W + Pembrolizumab 200 mg Q3W | 3/3 (100%) | 1/3 (33.3%) | 3/3 (100%) |
| Arm 2 Boserolimab 7 mg Q3W + Pembrolizumab 200 mg Q3W | 3/3 (100%) | 0/3 (0%) | 3/3 (100%) |
| Arm 2 Boserolimab 20 mg Q3W + Pembrolizumab 200 mg Q3W | 4/4 (100%) | 1/3 (33.3%) | 3/3 (100%) |
| Arm 2 Boserolimab 70 mg Q3W + Pembrolizumab 200 mg Q3W | 7/7 (100%) | 1/7 (14.3%) | 7/7 (100%) |
| Arm 2 Boserolimab 200 mg Q3W + Pembrolizumab 200 mg Q3W | 12/14 (85.7%) | 3/14 (21.4%) | 14/14 (100%) |
| Arm 2a Boserolimab 30 mg Q3W + Pembrolizumab 200 mg Q3W (TNBC) | 29/31 (93.5%) | 11/30 (36.7%) | 30/30 (100%) |
| Arm 2b Boserolimab 30 mg Q3W + Pembrolizumab 200 mg Q3W (Endometrial) | 14/15 (93.3%) | 2/15 (13.3%) | 15/15 (100%) |
| Arm 2c Boserolimab 30 mg Q6W + Pembrolizumab 400 mg Q6W (Endometrial) | 10/14 (71.4%) | 0/13 (0%) | 13/13 (100%) |
| Arm 3 Boserolimab 30 mg Q3W + Pembrolizumab 200 mg Q3W + Pemetrexed + Carboplatin (NSCLC) | 8/10 (80%) | 9/10 (90%) | 10/10 (100%) |
| Arm 4 Boserolimab 30 mg Q6W + Pembrolizumab 400 mg Q6W + Nab-paclitaxel (TNBC) | 18/41 (43.9%) | 13/41 (31.7%) | 40/41 (97.6%) |
| Switch-over Arm 1 Boserolimab 2 mg Q3W To Boserolimab 2 mg + Pembrolizumab 200 mg Q3W | 0/1 (0%) | 0/1 (0%) | 1/1 (100%) |
| Switch-over Arm 1 Boserolimab 7 mg Q3W To Boserolimab 2 mg + Pembrolizumab 200 mg Q3W | 1/1 (100%) | 0/1 (0%) | 1/1 (100%) |
| Switch-over Arm 1 Boserolimab 20 mg Q3W To Boserolimab 7 mg + Pembrolizumab 200 mg Q3W | 2/2 (100%) | 1/2 (50%) | 2/2 (100%) |
| Switch-over Arm 1 Boserolimab 20 mg Q3W To Boserolimab 20 mg + Pembrolizumab 200 mg Q3W | 2/3 (66.7%) | 1/3 (33.3%) | 3/3 (100%) |
| Switch-over Arm 1 Boserolimab 70 mg Q3W To Boserolimab 20 mg + Pembrolizumab 200 mg Q3W | 1/2 (50%) | 0/2 (0%) | 2/2 (100%) |
| Switch-over Arm 1 Boserolimab 200 mg Q3W To Boserolimab 20 mg + Pembrolizumab 200 mg Q3W | 2/2 (100%) | 2/2 (100%) | 2/2 (100%) |
| Switch-over Arm 1 Boserolimab 200 mg Q3W To Boserolimab 70 mg + Pembrolizumab 200 mg Q3W | 0/2 (0%) | 0/2 (0%) | 2/2 (100%) |
| Switch-over Arm 1 Boserolimab 200 mg Q3W To Boserolimab 200 mg + Pembrolizumab 200 mg Q3W | 1/1 (100%) | 0/1 (0%) | 1/1 (100%) |
| Switch-over Arm 1a Boserolimab 30mg Q3W (Endometrial) To Boserolimab 30mg + Pembrolizumab 200mg Q3W | 6/9 (66.7%) | 3/9 (33.3%) | 8/9 (88.9%) |
| Event | Arm 1 Boserolimab 2 mg Q3W | Arm 1 Boserolimab 7 mg Q3W | Arm 1 Boserolimab 20 mg Q3W | Arm 1 Boserolimab 70 mg Q3W | Arm 1 Boserolimab 200 mg Q3W | Arm 1 Boserolimab 700 mg Q3W | Arm 1a Boserolimab 30 mg Q3W (Endometrial) | Arm 2 Boserolimab 2 mg Q3W + Pembrolizumab 200 mg Q3W | Arm 2 Boserolimab 7 mg Q3W + Pembrolizumab 200 mg Q3W | Arm 2 Boserolimab 20 mg Q3W + Pembrolizumab 200 mg Q3W | Arm 2 Boserolimab 70 mg Q3W + Pembrolizumab 200 mg Q3W | Arm 2 Boserolimab 200 mg Q3W + Pembrolizumab 200 mg Q3W | Arm 2a Boserolimab 30 mg Q3W + Pembrolizumab 200 mg Q3W (TNBC) | Arm 2b Boserolimab 30 mg Q3W + Pembrolizumab 200 mg Q3W (Endometrial) | Arm 2c Boserolimab 30 mg Q6W + Pembrolizumab 400 mg Q6W (Endometrial) | Arm 3 Boserolimab 30 mg Q3W + Pembrolizumab 200 mg Q3W + Pemetrexed + Carboplatin (NSCLC) | Arm 4 Boserolimab 30 mg Q6W + Pembrolizumab 400 mg Q6W + Nab-paclitaxel (TNBC) | Switch-over Arm 1 Boserolimab 2 mg Q3W To Boserolimab 2 mg + Pembrolizumab 200 mg Q3W | Switch-over Arm 1 Boserolimab 7 mg Q3W To Boserolimab 2 mg + Pembrolizumab 200 mg Q3W | Switch-over Arm 1 Boserolimab 20 mg Q3W To Boserolimab 7 mg + Pembrolizumab 200 mg Q3W | Switch-over Arm 1 Boserolimab 20 mg Q3W To Boserolimab 20 mg + Pembrolizumab 200 mg Q3W | Switch-over Arm 1 Boserolimab 70 mg Q3W To Boserolimab 20 mg + Pembrolizumab 200 mg Q3W | Switch-over Arm 1 Boserolimab 200 mg Q3W To Boserolimab 20 mg + Pembrolizumab 200 mg Q3W | Switch-over Arm 1 Boserolimab 200 mg Q3W To Boserolimab 70 mg + Pembrolizumab 200 mg Q3W | Switch-over Arm 1 Boserolimab 200 mg Q3W To Boserolimab 200 mg + Pembrolizumab 200 mg Q3W | Switch-over Arm 1a Boserolimab 30mg Q3W (Endometrial) To Boserolimab 30mg + Pembrolizumab 200mg Q3W |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Abdominal painGastrointestinal disorders | 0/3 | 0/3 | 0/6 | 0/3 | 0/8 | 0/2 | 0/14 | 0/3 | 0/3 | 0/3 | 0/7 | 0/14 | 0/30 | 0/15 | 0/13 | 0/10 | 1/41 | 0/1 | 0/1 | 0/2 | 0/3 | 0/2 | 1/2 | 0/2 | 0/1 | 0/9 |
| Pulmonary sepsisInfections and infestations | 0/3 | 0/3 | 0/6 | 0/3 | 0/8 | 1/2 | 0/14 | 0/3 | 0/3 | 0/3 | 0/7 | 0/14 | 0/30 | 0/15 | 0/13 | 0/10 | 0/41 | 0/1 | 0/1 | 0/2 | 0/3 | 0/2 | 0/2 | 0/2 | 0/1 | 0/9 |
| Myasthenia gravisNervous system disorders | 0/3 | 0/3 | 0/6 | 0/3 | 0/8 | 0/2 | 0/14 | 0/3 | 0/3 | 0/3 | 0/7 | 0/14 | 0/30 | 0/15 | 0/13 | 0/10 | 0/41 | 0/1 | 0/1 | 1/2 | 0/3 | 0/2 | 0/2 | 0/2 | 0/1 | 0/9 |
| Acute kidney injuryRenal and urinary disorders | 0/3 | 0/3 | 0/6 | 0/3 | 0/8 | 0/2 | 0/14 | 0/3 | 0/3 | 0/3 | 0/7 | 0/14 | 0/30 | 0/15 | 0/13 | 0/10 | 1/41 | 0/1 | 0/1 | 0/2 | 0/3 | 0/2 | 1/2 | 0/2 | 0/1 | 0/9 |
| Haemorrhoidal haemorrhageGastrointestinal disorders | 0/3 | 0/3 | 0/6 | 0/3 | 0/8 | 0/2 | 0/14 | 0/3 | 0/3 | 0/3 | 0/7 | 0/14 | 0/30 | 0/15 | 0/13 | 0/10 | 0/41 | 0/1 | 0/1 | 0/2 | 1/3 | 0/2 | 0/2 | 0/2 | 0/1 | 0/9 |
| Tumour painNeoplasms benign, malignant and unspecified (incl cysts and polyps) | 0/3 | 0/3 | 0/6 | 0/3 | 0/8 | 0/2 | 0/14 | 1/3 | 0/3 | 0/3 | 0/7 | 0/14 | 0/30 | 0/15 | 0/13 | 0/10 | 1/41 | 0/1 | 0/1 | 0/2 | 0/3 | 0/2 | 0/2 | 0/2 | 0/1 | 0/9 |
| HaematuriaRenal and urinary disorders | 1/3 | 0/3 | 0/6 | 0/3 | 0/8 | 0/2 | 0/14 | 0/3 | 0/3 | 0/3 | 0/7 | 0/14 | 0/30 | 0/15 | 0/13 | 0/10 | 0/41 | 0/1 | 0/1 | 0/2 | 0/3 | 0/2 | 0/2 | 0/2 | 0/1 | 0/9 |
| Tubulointerstitial nephritisRenal and urinary disorders | 0/3 | 0/3 | 0/6 | 0/3 | 0/8 | 0/2 | 0/14 | 0/3 | 0/3 | 1/3 | 0/7 | 0/14 | 0/30 | 0/15 | 0/13 | 0/10 | 0/41 | 0/1 | 0/1 | 0/2 | 0/3 | 0/2 | 0/2 | 0/2 | 0/1 | 0/9 |
| CellulitisInfections and infestations | 0/3 | 0/3 | 0/6 | 0/3 | 0/8 | 0/2 | 0/14 | 0/3 | 0/3 | 0/3 | 0/7 | 0/14 | 0/30 | 0/15 | 0/13 | 2/10 | 0/41 | 0/1 | 0/1 | 0/2 | 0/3 | 0/2 | 0/2 | 0/2 | 0/1 | 0/9 |
| PneumoniaInfections and infestations | 0/3 | 0/3 | 0/6 | 0/3 | 0/8 | 0/2 | 0/14 | 0/3 | 0/3 | 0/3 | 0/7 | 0/14 | 0/30 | 0/15 | 0/13 | 2/10 | 0/41 | 0/1 | 0/1 | 0/2 | 0/3 | 0/2 | 0/2 | 0/2 | 0/1 | 0/9 |
| Event | Arm 1 Boserolimab 2 mg Q3W | Arm 1 Boserolimab 7 mg Q3W | Arm 1 Boserolimab 20 mg Q3W | Arm 1 Boserolimab 70 mg Q3W | Arm 1 Boserolimab 200 mg Q3W | Arm 1 Boserolimab 700 mg Q3W | Arm 1a Boserolimab 30 mg Q3W (Endometrial) | Arm 2 Boserolimab 2 mg Q3W + Pembrolizumab 200 mg Q3W | Arm 2 Boserolimab 7 mg Q3W + Pembrolizumab 200 mg Q3W | Arm 2 Boserolimab 20 mg Q3W + Pembrolizumab 200 mg Q3W | Arm 2 Boserolimab 70 mg Q3W + Pembrolizumab 200 mg Q3W | Arm 2 Boserolimab 200 mg Q3W + Pembrolizumab 200 mg Q3W | Arm 2a Boserolimab 30 mg Q3W + Pembrolizumab 200 mg Q3W (TNBC) | Arm 2b Boserolimab 30 mg Q3W + Pembrolizumab 200 mg Q3W (Endometrial) | Arm 2c Boserolimab 30 mg Q6W + Pembrolizumab 400 mg Q6W (Endometrial) | Arm 3 Boserolimab 30 mg Q3W + Pembrolizumab 200 mg Q3W + Pemetrexed + Carboplatin (NSCLC) | Arm 4 Boserolimab 30 mg Q6W + Pembrolizumab 400 mg Q6W + Nab-paclitaxel (TNBC) | Switch-over Arm 1 Boserolimab 2 mg Q3W To Boserolimab 2 mg + Pembrolizumab 200 mg Q3W | Switch-over Arm 1 Boserolimab 7 mg Q3W To Boserolimab 2 mg + Pembrolizumab 200 mg Q3W | Switch-over Arm 1 Boserolimab 20 mg Q3W To Boserolimab 7 mg + Pembrolizumab 200 mg Q3W | Switch-over Arm 1 Boserolimab 20 mg Q3W To Boserolimab 20 mg + Pembrolizumab 200 mg Q3W | Switch-over Arm 1 Boserolimab 70 mg Q3W To Boserolimab 20 mg + Pembrolizumab 200 mg Q3W | Switch-over Arm 1 Boserolimab 200 mg Q3W To Boserolimab 20 mg + Pembrolizumab 200 mg Q3W | Switch-over Arm 1 Boserolimab 200 mg Q3W To Boserolimab 70 mg + Pembrolizumab 200 mg Q3W | Switch-over Arm 1 Boserolimab 200 mg Q3W To Boserolimab 200 mg + Pembrolizumab 200 mg Q3W | Switch-over Arm 1a Boserolimab 30mg Q3W (Endometrial) To Boserolimab 30mg + Pembrolizumab 200mg Q3W |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| AnaemiaBlood and lymphatic system disorders | 0/3 | 0/3 | 0/6 | 0/3 | 0/8 | 0/2 | 2/14 | 0/3 | 0/3 | 1/3 | 0/7 | 2/14 | 1/30 | 2/15 | 1/13 | 5/10 | 18/41 | 1/1 | 0/1 | 0/2 | 0/3 | 1/2 | 0/2 | 0/2 | 0/1 | 1/9 |
| PalpitationsCardiac disorders | 0/3 | 0/3 | 0/6 | 0/3 | 0/8 | 0/2 | 0/14 | 0/3 | 0/3 | 0/3 | 0/7 | 0/14 | 0/30 | 1/15 | 0/13 | 1/10 | 0/41 | 1/1 | 0/1 | 0/2 | 0/3 | 0/2 | 0/2 | 0/2 | 0/1 | 0/9 |
| HyperthyroidismEndocrine disorders | 0/3 | 0/3 | 0/6 | 0/3 | 0/8 | 0/2 | 1/14 | 0/3 | 0/3 | 1/3 | 0/7 | 1/14 | 4/30 | 1/15 | 1/13 | 0/10 | 3/41 | 1/1 | 0/1 | 0/2 | 0/3 | 0/2 | 0/2 | 0/2 | 0/1 | 0/9 |
| Abdominal painGastrointestinal disorders | 2/3 | 0/3 | 3/6 | 1/3 | 1/8 | 0/2 | 0/14 | 0/3 | 0/3 | 1/3 | 0/7 | 2/14 | 4/30 | 1/15 | 2/13 | 2/10 | 5/41 | 1/1 | 0/1 | 0/2 | 2/3 | 0/2 | 0/2 | 0/2 | 0/1 | 0/9 |
| DiarrhoeaGastrointestinal disorders | 0/3 | 0/3 | 1/6 | 0/3 | 3/8 | 1/2 | 1/14 | 0/3 | 1/3 | 0/3 | 1/7 | 0/14 | 3/30 | 6/15 | 1/13 | 5/10 | 18/41 | 1/1 | 0/1 | 0/2 | 0/3 | 0/2 | 0/2 | 0/2 | 0/1 | 1/9 |
| Faeces softGastrointestinal disorders | 0/3 | 0/3 | 0/6 | 0/3 | 0/8 | 0/2 | 0/14 | 0/3 | 0/3 | 0/3 | 1/7 | 1/14 | 0/30 | 1/15 | 0/13 | 1/10 | 0/41 | 1/1 | 0/1 | 0/2 | 0/3 | 0/2 | 0/2 | 0/2 | 0/1 | 1/9 |
| HaemorrhoidsGastrointestinal disorders | 1/3 | 0/3 | 0/6 | 0/3 | 0/8 | 0/2 | 1/14 | 0/3 | 0/3 | 0/3 | 0/7 | 0/14 | 0/30 | 1/15 | 0/13 | 1/10 | 1/41 | 1/1 | 0/1 | 0/2 | 0/3 | 0/2 | 0/2 | 0/2 | 0/1 | 0/9 |
| Hiatus herniaGastrointestinal disorders | 0/3 | 0/3 | 0/6 | 0/3 | 0/8 | 0/2 | 0/14 | 0/3 | 0/3 | 0/3 | 0/7 | 0/14 | 0/30 | 0/15 | 0/13 | 0/10 | 0/41 | 1/1 | 0/1 | 0/2 | 0/3 | 0/2 | 0/2 | 0/2 | 0/1 | 0/9 |
| NauseaGastrointestinal disorders | 1/3 | 0/3 | 4/6 | 0/3 | 2/8 | 0/2 | 2/14 | 0/3 | 2/3 | 2/3 | 2/7 | 2/14 | 12/30 | 4/15 | 5/13 | 5/10 | 22/41 | 1/1 | 0/1 | 0/2 | 0/3 | 1/2 | 0/2 | 0/2 | 0/1 | 0/9 |
| FatigueGeneral disorders | 2/3 | 2/3 | 3/6 | 0/3 | 1/8 | 0/2 | 3/14 | 1/3 | 1/3 | 2/3 | 6/7 | 9/14 | 18/30 | 4/15 | 3/13 | 6/10 | 25/41 | 1/1 | 0/1 | 0/2 | 2/3 | 0/2 | 0/2 | 0/2 | 0/1 | 1/9 |
Per protocol, baseline characteristics were not analyzed separately for the switch-over period.
| Age, Continuous(Years) | Arm 1 Boserolimab 2 mg Q3W | Arm 1 Boserolimab 7 mg Q3W | Arm 1 Boserolimab 20 mg Q3W | Arm 1 Boserolimab 70 mg Q3W | Arm 1 Boserolimab 200 mg Q3W | Arm 1 Boserolimab 700 mg Q3W | Arm 1a Boserolimab 30 mg Q3W (Endometrial) | Arm 2 Boserolimab 2 mg Q3W + Pembrolizumab 200 mg Q3W | Arm 2 Boserolimab 7 mg Q3W + Pembrolizumab 200 mg Q3W | Arm 2 Boserolimab 20 mg Q3W + Pembrolizumab 200 mg Q3W | Arm 2 Boserolimab 70 mg Q3W + Pembrolizumab 200 mg Q3W | Arm 2 Boserolimab 200 mg Q3W + Pembrolizumab 200 mg Q3W | Arm 2a Boserolimab 30 mg Q3W + Pembrolizumab 200 mg Q3W (TNBC) | Arm 2b Boserolimab 30 mg Q3W + Pembrolizumab 200 mg Q3W (Endometrial) | Arm 2c Boserolimab 30 mg Q6W + Pembrolizumab 400 mg Q6W (Endometrial) | Arm 3 Boserolimab 30 mg Q3W + Pembrolizumab 200 mg Q3W + Pemetrexed + Carboplatin (NSCLC) | Arm 4 Boserolimab 30 mg Q6W + Pembrolizumab 400 mg Q6W + Nab-paclitaxel (TNBC) | Total |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Mean | 55.3 ± 18.9 | 57.3 ± 18.0 | 57.0 ± 15.8 | 54.0 ± 15.7 | 61.6 ± 14.2 | 61.0 ± 2.8 | 71.6 ± 5.7 | 44.7 ± 15.6 | 50.0 ± 24.3 | 61.5 ± 6.2 | 59.9 ± 7.2 | 55.1 ± 16.1 | 50.4 ± 13.3 | 64.6 ± 7.1 | 68.5 ± 9.5 | 61.9 ± 9.4 | 51.7 ± 11.8 | 57.5 ± 13.6 |
| Sex: Female, Male(Participants) | Arm 1 Boserolimab 2 mg Q3W | Arm 1 Boserolimab 7 mg Q3W | Arm 1 Boserolimab 20 mg Q3W | Arm 1 Boserolimab 70 mg Q3W | Arm 1 Boserolimab 200 mg Q3W | Arm 1 Boserolimab 700 mg Q3W | Arm 1a Boserolimab 30 mg Q3W (Endometrial) | Arm 2 Boserolimab 2 mg Q3W + Pembrolizumab 200 mg Q3W | Arm 2 Boserolimab 7 mg Q3W + Pembrolizumab 200 mg Q3W | Arm 2 Boserolimab 20 mg Q3W + Pembrolizumab 200 mg Q3W | Arm 2 Boserolimab 70 mg Q3W + Pembrolizumab 200 mg Q3W | Arm 2 Boserolimab 200 mg Q3W + Pembrolizumab 200 mg Q3W | Arm 2a Boserolimab 30 mg Q3W + Pembrolizumab 200 mg Q3W (TNBC) | Arm 2b Boserolimab 30 mg Q3W + Pembrolizumab 200 mg Q3W (Endometrial) | Arm 2c Boserolimab 30 mg Q6W + Pembrolizumab 400 mg Q6W (Endometrial) | Arm 3 Boserolimab 30 mg Q3W + Pembrolizumab 200 mg Q3W + Pemetrexed + Carboplatin (NSCLC) | Arm 4 Boserolimab 30 mg Q6W + Pembrolizumab 400 mg Q6W + Nab-paclitaxel (TNBC) | Total |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Female | 2 | 1 | 2 | 2 | 5 | 2 | 14 | 2 | 0 | 1 | 7 | 10 | 31 | 15 | 14 | 6 | 41 | 155 |
| Male | 1 | 2 | 4 | 1 | 4 | 0 | 0 | 1 | 3 | 3 | 0 | 4 | 0 | 0 | 0 | 4 | 0 | 27 |
| Ethnicity (NIH/OMB)(Participants) | Arm 1 Boserolimab 2 mg Q3W | Arm 1 Boserolimab 7 mg Q3W | Arm 1 Boserolimab 20 mg Q3W | Arm 1 Boserolimab 70 mg Q3W | Arm 1 Boserolimab 200 mg Q3W | Arm 1 Boserolimab 700 mg Q3W | Arm 1a Boserolimab 30 mg Q3W (Endometrial) | Arm 2 Boserolimab 2 mg Q3W + Pembrolizumab 200 mg Q3W | Arm 2 Boserolimab 7 mg Q3W + Pembrolizumab 200 mg Q3W | Arm 2 Boserolimab 20 mg Q3W + Pembrolizumab 200 mg Q3W | Arm 2 Boserolimab 70 mg Q3W + Pembrolizumab 200 mg Q3W | Arm 2 Boserolimab 200 mg Q3W + Pembrolizumab 200 mg Q3W | Arm 2a Boserolimab 30 mg Q3W + Pembrolizumab 200 mg Q3W (TNBC) | Arm 2b Boserolimab 30 mg Q3W + Pembrolizumab 200 mg Q3W (Endometrial) | Arm 2c Boserolimab 30 mg Q6W + Pembrolizumab 400 mg Q6W (Endometrial) | Arm 3 Boserolimab 30 mg Q3W + Pembrolizumab 200 mg Q3W + Pemetrexed + Carboplatin (NSCLC) | Arm 4 Boserolimab 30 mg Q6W + Pembrolizumab 400 mg Q6W + Nab-paclitaxel (TNBC) | Total |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Hispanic or Latino | 0 | 0 | 0 | 0 | 1 | 0 | 0 | 0 | 0 | 0 | 1 | 0 | 0 | 0 | 1 | 0 | 11 | 14 |
| Not Hispanic or Latino | 3 | 3 | 6 | 3 | 5 | 2 | 14 | 3 | 3 | 4 | 6 | 14 | 26 | 14 | 13 | 9 | 30 | 158 |
| Unknown or Not Reported | 0 | 0 | 0 | 0 | 3 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 5 | 1 | 0 | 1 | 0 | 10 |
| Race (NIH/OMB)(Participants) | Arm 1 Boserolimab 2 mg Q3W | Arm 1 Boserolimab 7 mg Q3W | Arm 1 Boserolimab 20 mg Q3W | Arm 1 Boserolimab 70 mg Q3W | Arm 1 Boserolimab 200 mg Q3W | Arm 1 Boserolimab 700 mg Q3W | Arm 1a Boserolimab 30 mg Q3W (Endometrial) | Arm 2 Boserolimab 2 mg Q3W + Pembrolizumab 200 mg Q3W | Arm 2 Boserolimab 7 mg Q3W + Pembrolizumab 200 mg Q3W | Arm 2 Boserolimab 20 mg Q3W + Pembrolizumab 200 mg Q3W | Arm 2 Boserolimab 70 mg Q3W + Pembrolizumab 200 mg Q3W | Arm 2 Boserolimab 200 mg Q3W + Pembrolizumab 200 mg Q3W | Arm 2a Boserolimab 30 mg Q3W + Pembrolizumab 200 mg Q3W (TNBC) | Arm 2b Boserolimab 30 mg Q3W + Pembrolizumab 200 mg Q3W (Endometrial) | Arm 2c Boserolimab 30 mg Q6W + Pembrolizumab 400 mg Q6W (Endometrial) | Arm 3 Boserolimab 30 mg Q3W + Pembrolizumab 200 mg Q3W + Pemetrexed + Carboplatin (NSCLC) | Arm 4 Boserolimab 30 mg Q6W + Pembrolizumab 400 mg Q6W + Nab-paclitaxel (TNBC) | Total |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 00 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Asian | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 0 | 0 | 0 | 0 | 15 | 16 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Black or African American | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 0 | 0 | 0 | 0 | 0 | 0 | 2 | 0 | 0 | 0 | 3 |
| White | 3 | 3 | 6 | 3 | 6 | 2 | 13 | 3 | 3 | 4 | 7 | 13 | 30 | 13 | 14 | 10 | 26 | 159 |
| More than one race | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Unknown or Not Reported | 0 | 0 | 0 | 0 | 3 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 0 | 0 | 0 | 0 | 4 |
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: Yes — http://engagezone.msd.com/doc/ProcedureAccessClinicalTrialData.pdf
Data sharing details ↗ · engagezone.msd.com
Ran from Feb 2018 to primary completion in Sep 2024, 79 months.
Results were first posted in Nov 2025, 1 year 1 month after primary completion.
Of 473 industry-sponsored phase 1 interventional studies under Carcinoma, Non-Small-Cell Lung, half reached primary completion within 49 months of starting (the median), counting those still running; a quarter within 29 and three quarters within 66. This study's 79 months is above that.
Counting every sponsor, half of 699 studies reached it within 50 months; a quarter within 31 and three quarters within 70.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Oct 2025. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Boserolimab
Carcinoma, Non-Small-Cell Lung →