TerminatedNCT03515824Updated Mar 9, 2021Results posted

Study of MK-1697 in Participants With Advanced Solid Tumors (MK-1697-001)

A Phase 1 interventional study of MK-1697 in Neoplasms, Colorectal Neoplasms and Head and Neck Neoplasms, sponsored by Merck Sharp & Dohme LLC. Terminated at 2 sites in 2 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2021-03-09.

Sponsored by Merck Sharp & Dohme LLC · Phase 1, Interventional, and Treatment

Why this study was terminated

Business Reasons

Phase: Phase 1
Study type: Interventional
Enrollment: 22
Allocation: Non-randomized
Ages: 18 Years and older
Sex: All

Study summary

The purpose of this study is to evaluate the safety and preliminary efficacy of MK-1697. There are 2 parts in this study: dose escalation to determine the recommended phase 2 dose (RP2D) and confirm the RP2D (Part A) and cohort expansion to determine preliminary efficacy in participants with colorectal cancer (CRC) or head and neck squamous cell cancer (HNSCC) (Part B). No formal hypothesis testing will be done in this study.

Conditions studied

Neoplasms
Colorectal Neoplasms
Head and Neck Neoplasms

Browse trials for

Keywords

Programmed Cell Death Receptor 1 (PD-1)
Programmed Cell Death Receptor Ligand 1 (PD-L1)
PD-1
PDL1
PD-L1

In context

Neoplasms

9,365 studies on the registry are indexed under Neoplasms; 2,489 are open to participants now.

This study's enrollment of 22 is below the median of 50 across 7,253 interventional studies indexed under Neoplasms.

Browse Neoplasms studies →

Lead sponsor

Merck Sharp & Dohme LLC is the lead sponsor of 2,114 studies on the registry; 132 are open to participants now.

Of its 489 completed or terminated interventional studies of FDA-regulated products, 362 (74%) have results posted.

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

Inclusion criteria

For Part A; has a histologically- or cytologically-confirmed advanced/metastatic solid tumor and has received, been intolerant to, or been ineligible for all treatments known to confer clinical benefit
For Part B: has 1 of the following histologically or cytologically confirmed tumor types that are anti-programmed cell death protein 1 (anti PD-1)/anti-programmed death-ligand 1 (anti PD-L1) treatment naive:
- CRC originating in either the colon or rectum that is locally advanced unresectable or metastatic (ie, Stage IV) and that has received, and progressed on, all available standard-of-care therapies including fluoropyrimidine, oxaliplatin, and irinotecan
- HNSCC that is considered incurable by local therapies. The eligible primary tumor locations are oropharynx, oral cavity, hypopharynx, and larynx. Participants may not have a primary tumor site of nasopharynx (any histology). Also, participants must have progressed after receiving platinum-containing systemic therapy
Has measurable disease by Response Evaluation Criteria in Solid Tumors, version 1.1 (RECIST 1.1)
Has an evaluable baseline tumor sample (either a recent or archival) for analysis
Has an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
Has central venous access (eg, portacath, Hickman line, or peripherally inserted central catheter [PICC] line) currently inserted or be considered medically fit for and willing to undergo the insertion of such a device
Is not pregnant or breastfeeding
Female participants of childbearing potential must agree to use contraception during the treatment period and for at least 120 days after the last dose of study treatment
Male participants must agree to use contraception during the treatment period and for at least 120 days after the last dose of study treatment and refrain from donating sperm during this period

Exclusion criteria

Exclusion Criteria:

Has a history of a second malignancy, unless potentially curative treatment has been completed with no evidence of malignancy for 3 years with the exception of participants who underwent successful definitive resection of basal cell carcinoma of the skin, superficial bladder cancer or in situ cervical cancer, or other in-situ cancers
Has clinically active central nervous system (CNS) metastases and/or carcinomatous meningitis
Has had a severe hypersensitivity reaction to treatment with any monoclonal antibody and/or components of the study treatment
Has an active infection requiring therapy
Has a history of interstitial lung disease
Has a history of (noninfectious) pneumonitis that required steroids or current pneumonitis
Has an active autoimmune disease that has required systemic treatment in the past 2 years
Has known human immunodeficiency virus (HIV) and/or Hepatitis B or C infections, or known to be positive for Hepatitis B antigen/Hepatitis B virus deoxyribonucleic acid (DNA) or Hepatitis C Antibody or ribonucleic acid (RNA)
Has a history or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the study, interfere with participation, make administration of the study treatments hazardous, or make it difficult to monitor adverse effects in the opinion of the treating investigator
Has a history or current evidence of severe cardiovascular disease, ie, arrhythmias requiring chronic treatment, congestive heart failure (New York Heart Association [NYHA] Class III or IV) or symptomatic ischemic heart disease.
Has a known psychiatric or substance abuse disorder that would interfere with the participant's ability to cooperate with the requirements of the trial
Is pregnant or breastfeeding, or expecting to conceive or father children within the projected duration of the study, starting with the screening visit through 120 days after the last dose of study treatment
Has not fully recovered from any effects of major surgery without significant detectable infection. Surgeries that required general anesthesia must be completed at least 2 weeks before first study treatment administration. Surgery requiring regional/epidural anesthesia must be completed at least 72 hours before first study treatment administration and participants should be recovered
Has known microsatellite instability (MSI) high or mismatch repair genes (MMR) deficient colorectal cancer. If a participant's MSI status is unknown, a paired blood sample for MSI in addition to biomarker testing is required to determine MSI status retrospectively (for the CRC expansion cohort only)
Has a positive pregnancy test within 72 hours before the first dose of study treatment
Has had chemotherapy, definitive radiation, or biological cancer therapy within 4 weeks (2 weeks for palliative radiation) prior to the first dose of study therapy, or has not recovered to Common Terminology Criteria for Adverse Events (CTCAE) Grade 1 or better from any adverse events that were due to cancer therapeutics administered more than 4 weeks earlier
Has received prior therapy with an anti-Lymphocyte-activation gene 3 (LAG-3) agent
Has received a live vaccine within 30 days prior to the first dose of study drug
Has undergone a prior stem cell or bone marrow transplant within the last 5 years
Is expected to require any other form of antineoplastic therapy while on study
Is currently participating in or has participated in a study of an investigational agent or has used an investigational device within 4 weeks prior to the first dose of study treatment

Study design

Phase: Phase 1
Primary purpose: Treatment
Allocation: Non-randomized
Intervention model: Parallel assignment
Masking: None (open label)
Enrollment: 22 participants (actual)

Study arms

Experimental
Part A: MK-1696 20 mg
Participants received 20 mg of MK-1697 by intravenous (IV) infusion on Day 1 of each 21-day cycle for up to 35 administrations (up to approximately 2 years).
Biological: MK-1697
Experimental
Part A: MK-1697 65 mg
Participants received 65 mg of MK-1697 by IV infusion on Day 1 of each 21-day cycle for up to 35 administrations (up to approximately 2 years).
Biological: MK-1697
Experimental
Part A: MK-1697 200 mg
Participants received 200 mg of MK-1697 by IV infusion on Day 1 of each 21-day cycle for up to 35 administrations (up to approximately 2 years).
Biological: MK-1697
Experimental
Part B: Expansion Cohort
Participants with select tumor types were to receive MK-1697 at the RP2D by IV infusion on Day 1 of each 21-day cycle for up to 35 administrations (up to approximately 2 years).
Biological: MK-1697

Interventions

BiologicalMK-1697
Administered by IV infusion on Day 1 of each 21-day cycle

What researchers measure

Primary outcomes

Percentage of Participants Who Experienced a Dose Limiting Toxicity (DLT) During Cycle 1
The following toxicities were considered a DLT, if assessed as related to study treatment: Grade (Gr) 4 non-hematologic toxicity (T); Gr 4 hematologic T for ≥7 days; Gr 4 thrombocytopenia; Gr 3 thrombocytopenia with bleeding; ≥Gr 3 non-hematologic clinical AE except fatigue for ≤3 days, Gr 3 nausea, vomiting, or diarrhea for \>72 hours despite anti-emetics/diarrheals, or other supportive care; Gr 3 rash without corticosteroids/anti-inflammatory agents use per standard of care; Gr 3/4 non-hematologic laboratory value if: medical intervention is required, abnormality leads to hospitalization, persists for \>1 week, or abnormality results in drug-induced liver injury; Gr 3 or 4 febrile neutropenia; treatment-related T causing discontinuation; inability to administer ≥75% of planned dose due to drug-related tolerability; Gr 5 T; delay in Cycle 2 start by \>2 weeks due to T. Pool-adjacent violators algorithm was used to estimate DLT rate \& Bayesian method for 80% confidence intervals (CIs).
Time frame: Up to 21 days of Cycle 1 (cycle length = 21 days)
Number of Participants Who Experienced At Least One Adverse Event (AE)
An AE is any untoward medical occurrence in a participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a study treatment. The number of participants who experienced at least one AE were presented.
Time frame: Up to approximately 9 months
Number of Participants Who Discontinued Study Intervention Due to an Adverse Event (AE)
An AE is any untoward medical occurrence in a participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a study treatment. The number of participants who discontinued study intervention due to an AE were presented.
Time frame: Up to approximately 8 months

Secondary outcomes

Objective Response Rate (ORR) Per Response Evaluation Criteria In Solid Tumors Version 1.1 (RECIST 1.1)
An objective response was defined as a complete response (CR: Disappearance of all target lesions) or partial response (PR: At least a 30% decrease in the sum of diameters of target lesions) as assessed by the investigator based on RECIST 1.1 following administration of MK-1697. ORR was reported as percentage of participants who experienced an CR or PR after administration of MK-1967. The exact method based on the binomial distribution (Clopper-Pearson interval) was used to estimate ORR and its associated 95%CIs.
Time frame: Up to approximately 18 months (through End of Trial data cut-off 18 Feb 2020)
Objective Response Rate (ORR) Per Modified Response Evaluation Criteria In Solid Tumors Version 1.1 for Immune-based Therapeutics (iRECIST)
An objective response was defined as an immune-based complete response (iCR: Disappearance of all target lesions) or immune-based partial response (iPR: At least a 30% decrease in the sum of diameters of target lesions). ORR was reported as percentage of participants who experienced an iCR or iPR after administration of MK-1967. Participants were initially assessed for progressive disease (PD : ≥20% increase in sum of diameters \[SD\] of target lesions or relative increase of 20%, sum must demonstrate an absolute increase of ≥5 mm or appearance of one/more new lesions) per RECIST 1.1 by local site investigator; later verified by central imaging vendor. Investigator could elect to continue treatment and tumor assessment repeated 4-8 weeks later to confirm PD by iRECIST. The exact method based on the binomial distribution (Clopper-Pearson interval) was used to estimate ORR and its associated 95%CIs.
Time frame: Up to approximately 18 months (through End of Trial data cut-off 18 Feb 2020)
Area Under the Concentration-Time Curve From Time 0 to Infinity (AUC 0-inf) of MK-1697
Serum samples were collected at specified time points for determination of MK-1697 AUC 0-inf. AUC 0-inf was defined as the area under the concentration-time curve of MK-1697 from time zero to infinity for all participants in Part A for each dose group.
Time frame: Cycle 1-3: Days 1, 2 (only Cycle 1), 3, 8, 15 - predose and postdose at 10 minutes, 2 hours (cycle length = 21 days)
Area Under the Concentration Time Curve From Time Zero to Last Concentration (AUC 0-last) Measured of MK-1697
Serum samples were collected at specified time points for determination of AUC 0-last of MK-1697. AUC 0-last was defined as the area under the concentration-time curve of MK-1697 from time zero to the last concentration of MK-1697 measured for all participants in Part A for each dose group.
Time frame: Cycles 1, 2, and 3: predose, 10 minutes and 2 hours post-dose (cycle length = 21 days)
Maximum Serum Concentration (Cmax) of MK-1697
Serum samples were collected at specified time points for determination of MK-1697 Cmax. Cmax was defined as the maximum concentration of MK-1697 reached for all participants in Part A for each dose group.
Time frame: Cycle 1-3: Days 1, 2 (only Cycle 1), 3, 8, 15 - predose and postdose at 10 minutes, 2 hours (cycle length = 21 days)
Minimum Serum Concentration (Cmin) of MK-1697
Serum samples were collected pre-dose at specified time points (Cycles 1, 2, 3, 5, 7, and 11) for the determination of MK-1697 Ctrough (may also be referred to as Cmin) per protocol. Ctrough was defined as the lowest concentration of MK-1697 reached before the next dose was administered. Serum Ctrough of MK-1697 was reported for all participants in Part A for each dose group.
Time frame: Cycles 1-3, 5, 7, 11: Days 1, 2 (only Cycle 1), 3, 8, 15 - predose and postdose at 10 minutes, 2 hours (cycle length = 21 days)

Results

Posted Feb 12, 2021

Limitations and caveats

The study was terminated due to business reasons.

Participant flow

Participant flow — Overall Study
Milestone	Part A: MK-1697 20 mg	Part A: MK-1697 65 mg	Part A: MK-1697 200 mg
Started	3	4	15
Completed	0	0	0
Not completed	3	4	15
Withdrew: Death	3	2	6
Withdrew: Lost to follow-up	0	1	1
Withdrew: Study terminated by sponsor	0	1	6
Withdrew: Status not recorded	0	0	2

Outcome measures

PrimaryPercentage of Participants Who Experienced a Dose Limiting Toxicity (DLT) During Cycle 1

The following toxicities were considered a DLT, if assessed as related to study treatment: Grade (Gr) 4 non-hematologic toxicity (T); Gr 4 hematologic T for ≥7 days; Gr 4 thrombocytopenia; Gr 3 thrombocytopenia with bleeding; ≥Gr 3 non-hematologic clinical AE except fatigue for ≤3 days, Gr 3 nausea, vomiting, or diarrhea for \>72 hours despite anti-emetics/diarrheals, or other supportive care; Gr 3 rash without corticosteroids/anti-inflammatory agents use per standard of care; Gr 3/4 non-hematologic laboratory value if: medical intervention is required, abnormality leads to hospitalization, persists for \>1 week, or abnormality results in drug-induced liver injury; Gr 3 or 4 febrile neutropenia; treatment-related T causing discontinuation; inability to administer ≥75% of planned dose due to drug-related tolerability; Gr 5 T; delay in Cycle 2 start by \>2 weeks due to T. Pool-adjacent violators algorithm was used to estimate DLT rate \& Bayesian method for 80% confidence intervals (CIs).

Time frame:: Up to 21 days of Cycle 1 (cycle length = 21 days)
Reported as:: Count of participants · Participants

Percentage of Participants Who Experienced a Dose Limiting Toxicity (DLT) During Cycle 1
Participants	Part A: MK-1697 20 mg	Part A: MK-1697 65 mg	Part A: MK-1697 200 mg
Percentage of Participants Who Experienced a Dose Limiting Toxicity (DLT) During Cycle 1	0	0	2

Statistical analysis

Part A: MK-1697 20 mg · Pooled-adjacent-violator algorithm: 0.0 · 80% CI 0.0 to 33.1
Part A: MK-1697 65 mg · Pooled-adjacent-violator algorithm: 0.0 · 80% CI 0.0 to 33.1
Part A: MK-1697 200 mg · Pooled-adjacent-violator algorithm: 15.4 · 80% CI 5.8 to 30.2

PrimaryNumber of Participants Who Experienced At Least One Adverse Event (AE)

An AE is any untoward medical occurrence in a participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a study treatment. The number of participants who experienced at least one AE were presented.

Time frame:: Up to approximately 9 months
Reported as:: Count of participants · Participants

Number of Participants Who Experienced At Least One Adverse Event (AE)
Participants	Part A: MK-1697 20 mg	Part A: MK-1697 65 mg	Part A: MK-1697 200 mg
Number of Participants Who Experienced At Least One Adverse Event (AE)	3	4	14

PrimaryNumber of Participants Who Discontinued Study Intervention Due to an Adverse Event (AE)

Time frame:: Up to approximately 8 months
Reported as:: Count of participants · Participants

Number of Participants Who Discontinued Study Intervention Due to an Adverse Event (AE)
Participants	Part A: MK-1697 20 mg	Part A: MK-1697 65 mg	Part A: MK-1697 200 mg
Number of Participants Who Discontinued Study Intervention Due to an Adverse Event (AE)	0	1	3

SecondaryObjective Response Rate (ORR) Per Response Evaluation Criteria In Solid Tumors Version 1.1 (RECIST 1.1)

An objective response was defined as a complete response (CR: Disappearance of all target lesions) or partial response (PR: At least a 30% decrease in the sum of diameters of target lesions) as assessed by the investigator based on RECIST 1.1 following administration of MK-1697. ORR was reported as percentage of participants who experienced an CR or PR after administration of MK-1967. The exact method based on the binomial distribution (Clopper-Pearson interval) was used to estimate ORR and its associated 95%CIs.

Time frame:: Up to approximately 18 months (through End of Trial data cut-off 18 Feb 2020)
Reported as:: Number · Percentage of Participants

Objective Response Rate (ORR) Per Response Evaluation Criteria In Solid Tumors Version 1.1 (RECIST 1.1)
Percentage of Participants	Part A: MK-1697 20 mg	Part A: MK-1697 65 mg	Part A: MK-1697 200 mg
Objective Response Rate (ORR) Per Response Evaluation Criteria In Solid Tumors Version 1.1 (RECIST 1.1)	0.0	0.0	0.0

Statistical analysis

Part A: MK-1697 20 mg · Objective response rate (orr): 0.0 · 95% CI 0.0 to 70.8
Part A: MK-1697 65 mg · Objective response rate (orr): 0.0 · 95% CI 0.0 to 60.2
Part A: MK-1697 200 mg · Objective response rate (orr): 0.0 · 95% CI 0.0 to 21.8

SecondaryObjective Response Rate (ORR) Per Modified Response Evaluation Criteria In Solid Tumors Version 1.1 for Immune-based Therapeutics (iRECIST)

An objective response was defined as an immune-based complete response (iCR: Disappearance of all target lesions) or immune-based partial response (iPR: At least a 30% decrease in the sum of diameters of target lesions). ORR was reported as percentage of participants who experienced an iCR or iPR after administration of MK-1967. Participants were initially assessed for progressive disease (PD : ≥20% increase in sum of diameters \[SD\] of target lesions or relative increase of 20%, sum must demonstrate an absolute increase of ≥5 mm or appearance of one/more new lesions) per RECIST 1.1 by local site investigator; later verified by central imaging vendor. Investigator could elect to continue treatment and tumor assessment repeated 4-8 weeks later to confirm PD by iRECIST. The exact method based on the binomial distribution (Clopper-Pearson interval) was used to estimate ORR and its associated 95%CIs.

Time frame:: Up to approximately 18 months (through End of Trial data cut-off 18 Feb 2020)
Reported as:: Number · Percentage of Participants

Objective Response Rate (ORR) Per Modified Response Evaluation Criteria In Solid Tumors Version 1.1 for Immune-based Therapeutics (iRECIST)
Percentage of Participants	Part A: MK-1697 20 mg	Part A: MK-1697 65 mg	Part A: MK-1697 200 mg
Objective Response Rate (ORR) Per Modified Response Evaluation Criteria In Solid Tumors Version 1.1 for Immune-based Therapeutics (iRECIST)	0.0	0.0	0.0

Statistical analysis

Part A: MK-1697 20 mg · Objective response rate (orr): 0 · 95% CI 0.0 to 84.2
Part A: MK-1697 65 mg · Objective response rate (orr): 0.0 · 95% CI 0.0 to 70.8
Part A: MK-1697 200 mg · Objective response rate )orr): 0.0 · 95% CI 0.0 to 28.5

SecondaryArea Under the Concentration-Time Curve From Time 0 to Infinity (AUC 0-inf) of MK-1697

Serum samples were collected at specified time points for determination of MK-1697 AUC 0-inf. AUC 0-inf was defined as the area under the concentration-time curve of MK-1697 from time zero to infinity for all participants in Part A for each dose group.

Time frame:: Cycle 1-3: Days 1, 2 (only Cycle 1), 3, 8, 15 - predose and postdose at 10 minutes, 2 hours (cycle length = 21 days)
Reported as:: Geometric mean · Day*ng/mL

Area Under the Concentration-Time Curve From Time 0 to Infinity (AUC 0-inf) of MK-1697
Day*ng/mL	Part A: MK-1697 20 mg	Part A: MK-1697 65 mg	Part A: MK-1697 200 mg
Cycle 1	29500 ± 106.3	143000 ± 40.9	456000 ± 25.6
Cycle 2	23400 ± 65.4	168000 ± 42.1	499000 ± 47.9
Cycle 3	29300 ± 64.0	188000 ± 53.0	555000 ± 42.1

SecondaryArea Under the Concentration Time Curve From Time Zero to Last Concentration (AUC 0-last) Measured of MK-1697

Serum samples were collected at specified time points for determination of AUC 0-last of MK-1697. AUC 0-last was defined as the area under the concentration-time curve of MK-1697 from time zero to the last concentration of MK-1697 measured for all participants in Part A for each dose group.

Time frame:: Cycles 1, 2, and 3: predose, 10 minutes and 2 hours post-dose (cycle length = 21 days)
Reported as:: Geometric mean · Day*ng/mL

Area Under the Concentration Time Curve From Time Zero to Last Concentration (AUC 0-last) Measured of MK-1697
Day*ng/mL	Part A: MK-1697 20 mg	Part A: MK-1697 65 mg	Part A: MK-1697 200 mg
Cycle 1	27700 ± 103.0	99000 ± 59.7	280000 ± 143.1
Cycle 2	28000 ± 60.9	141000 ± 34.3	418000 ± 38.4
Cycle 3	8220 ± 763.8	162000 ± 49.8	442000 ± 35.1

SecondaryMaximum Serum Concentration (Cmax) of MK-1697

Serum samples were collected at specified time points for determination of MK-1697 Cmax. Cmax was defined as the maximum concentration of MK-1697 reached for all participants in Part A for each dose group.

Time frame:: Cycle 1-3: Days 1, 2 (only Cycle 1), 3, 8, 15 - predose and postdose at 10 minutes, 2 hours (cycle length = 21 days)
Reported as:: Geometric mean · ng/mL

Maximum Serum Concentration (Cmax) of MK-1697
ng/mL	Part A: MK-1697 20 mg	Part A: MK-1697 65 mg	Part A: MK-1697 200 mg
Cycle 1	5520 ± 89.9	16900 ± 31.2	60200 ± 12.5
Cycle 2	5850 ± 37.5	21800 ± 31.5	58500 ± 27.8
Cycle 3	5560 ± 41.4	22500 ± 33.9	61200 ± 18.7

SecondaryMinimum Serum Concentration (Cmin) of MK-1697

Serum samples were collected pre-dose at specified time points (Cycles 1, 2, 3, 5, 7, and 11) for the determination of MK-1697 Ctrough (may also be referred to as Cmin) per protocol. Ctrough was defined as the lowest concentration of MK-1697 reached before the next dose was administered. Serum Ctrough of MK-1697 was reported for all participants in Part A for each dose group.

Time frame:: Cycles 1-3, 5, 7, 11: Days 1, 2 (only Cycle 1), 3, 8, 15 - predose and postdose at 10 minutes, 2 hours (cycle length = 21 days)
Reported as:: Geometric mean · ng/mL

Minimum Serum Concentration (Cmin) of MK-1697
ng/mL	Part A: MK-1697 20 mg	Part A: MK-1697 65 mg	Part A: MK-1697 200 mg
Cycle 1	127 ± 995.6	1310 ± 107.0	3230 ± 870.7
Cycle 2	125 ± 556.0	2210 ± 59.6	5350 ± 190.0
Cycle 3	566 ± NA	2390 ± 61.8	7000 ± 82.0
Cycle 5	544 ± NA	2540 ± 129.0	9590 ± 43.4
Cycle 7	580 ± NA	3000 ± 79.4	—
Cycle 11	631 ± NA	—	—

Adverse events

Collected over Non-serious AEs were collected for up to approximately 9 months. All-cause mortality and serious AEs were collected for up to approximately 14 months.. Non-serious events are listed at a 5% frequency threshold.

Adverse event summary by group
Group	Deaths	Serious	Other
Part A: MK-1697 20 mg	3/3 (100%)	1/3 (33.3%)	3/3 (100%)
Part A: MK-1697 65 mg	2/4 (50%)	1/4 (25%)	4/4 (100%)
Part A: MK-1697 200 mg	6/15 (40%)	7/15 (46.7%)	14/15 (93.3%)

Most frequent serious events

Showing 10 of 23

Most frequent serious events
Event	Part A: MK-1697 20 mg	Part A: MK-1697 65 mg	Part A: MK-1697 200 mg
Toxicity to various agentsInjury, poisoning and procedural complications	1/3	0/4	0/15
HyperglycaemiaMetabolism and nutrition disorders	0/3	1/4	0/15
Malignant ascitesNeoplasms benign, malignant and unspecified (incl cysts and polyps)	0/3	1/4	0/15
AnaemiaBlood and lymphatic system disorders	0/3	0/4	3/15
Adrenal insufficiencyEndocrine disorders	0/3	0/4	1/15
Duodenal ulcerGastrointestinal disorders	0/3	0/4	1/15
PancreatitisGastrointestinal disorders	0/3	0/4	1/15
HypothermiaGeneral disorders	0/3	0/4	1/15
Oedema peripheralGeneral disorders	0/3	0/4	1/15
HepatitisHepatobiliary disorders	0/3	0/4	1/15

Most frequent other events

Showing 10 of 80

Most frequent other events
Event	Part A: MK-1697 20 mg	Part A: MK-1697 65 mg	Part A: MK-1697 200 mg
AnaemiaBlood and lymphatic system disorders	2/3	1/4	5/15
NauseaGastrointestinal disorders	2/3	0/4	3/15
FatigueGeneral disorders	2/3	0/4	0/15
Lipase increasedInvestigations	0/3	2/4	2/15
HyperglycaemiaMetabolism and nutrition disorders	0/3	2/4	0/15
Back painMusculoskeletal and connective tissue disorders	0/3	2/4	4/15
PruritusSkin and subcutaneous tissue disorders	1/3	2/4	6/15
Abdominal painGastrointestinal disorders	1/3	0/4	3/15
ConstipationGastrointestinal disorders	1/3	0/4	3/15
GlossodyniaGastrointestinal disorders	1/3	0/4	0/15

Baseline characteristics

No participants were enrolled in Part B since study was terminated at the completion of Part A.

Age, Continuous
Age, Continuous(Years)	Part A: MK-1697 20 mg	Part A: MK-1697 65 mg	Part A: MK-1697 200 mg	Total
Mean	62.3 ± 8.4	57.3 ± 19.8	51.8 ± 14.5	54.2 ± 14.8

Sex: Female, Male
Sex: Female, Male(Participants)	Part A: MK-1697 20 mg	Part A: MK-1697 65 mg	Part A: MK-1697 200 mg	Total
Female	1	1	10	12
Male	2	3	5	10

Ethnicity (NIH/OMB)
Ethnicity (NIH/OMB)(Participants)	Part A: MK-1697 20 mg	Part A: MK-1697 65 mg	Part A: MK-1697 200 mg	Total
Hispanic or Latino	0	0	0	0
Not Hispanic or Latino	3	4	15	22
Unknown or Not Reported	0	0	0	0

Race (NIH/OMB)
Race (NIH/OMB)(Participants)	Part A: MK-1697 20 mg	Part A: MK-1697 65 mg	Part A: MK-1697 200 mg	Total
American Indian or Alaska Native	0	0	0	0
Asian	0	1	9	10
Native Hawaiian or Other Pacific Islander	0	0	0	0
Black or African American	0	0	0	0
White	3	3	6	12
More than one race	0	0	0	0
Unknown or Not Reported	0	0	0	0

Study locations

2 sites

Scientia Clinical Research ( Site 0100)
Randwick, New South Wales 2031, Australia
Queen Mary Hospital ( Site 0200)
Hong Kong, Hong Kong

References and documents

Study documents

Protocol and statistical analysis plan · May 23, 2019

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

Individual participant data

Plan to share: Yes — http://engagezone.msd.com/doc/ProcedureAccessClinicalTrialData.pdf

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on Mar 9, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT03515824
Lead sponsor: Merck Sharp & Dohme LLC
Responsible party: Sponsor
First posted: May 4, 2018
Start date: Aug 13, 2018
Primary completion: Feb 18, 2020
Completion: Feb 18, 2020
Results posted: Feb 12, 2021
Last update: Mar 9, 2021

Study contacts

Medical Director

study director · Merck Sharp & Dohme LLC

Oversight

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

View the source record on ClinicalTrials.gov ↗

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Study of MK-1697 in Participants With Advanced Solid Tumors (MK-1697-001)

Study summary

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Neoplasms

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