The purpose of this study is to evaluate the safety, tolerability, and preliminary efficacy of MK-6837, administered as a monotherapy and in combination with pembrolizumab (MK-3475), in participants with histologically or cytologically confirmed advanced/metastatic solid tumors that have not responded to conventional therapy. There will not be any hypothesis testing in the study. As of Amendment 04 (effective date: 18-Dec-2025), there are no pharmacokinetic (PK) secondary outcome measures in this study.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
168
IV Infusion
IV Infusion
Antihistamine, H2 receptor antagonist, acetaminophen (or equivalent), dexamethasone (or equivalent) administered per product label prior to MK-6837.
Atlantic Health System Morristown Medical Center ( Site 4001)
Morristown, New Jersey, United States
Providence Portland Medical Center ( Site 4002)
Portland, Oregon, United States
South Texas Accelerated Research Therapeutics (START) ( Site 4003)
San Antonio, Texas, United States
Westmead Hospital ( Site 1002)
Westmead, New South Wales, Australia
The Alfred Hospital ( Site 1001)
Melbourne, Victoria, Australia
Princess Margaret Cancer Centre ( Site 2001)
Toronto, Ontario, Canada
Sheba Medical Center-ONCOLOGY ( Site 3001)
Ramat Gan, Israel
Number of participants who experience one or more dose-limiting toxicities (DLTs)
The following events will be considered a DLT unless clearly due to underlying disease or extraneous causes: Grade 4 neutropenia lasting \>7 days; Grade 3 or higher thrombocytopenia associated with clinically significant bleeding, regardless of duration; All Grade 3 or higher nonhematologic toxicities (with exceptions); Any abnormality that results in a drug induced liver injury; Febrile neutropenia Grade 3 or 4; Prolonged delay (\>2 weeks) in initiating treatment after the first 21 days due to intervention-related toxicity; Any intervention-related toxicity that causes the participant to discontinue intervention during the first 21 days; Grade 5 toxicity. The number of participants who experience a DLT will be presented.
Time frame: Cycle 1 (Up to approximately 21 days); each cycle is 21 days.
Number of participants who experience one or more adverse events (AEs)
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention.
Time frame: Up to approximately 35 months
Number of participants who discontinue study intervention due to an AE
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention.
Time frame: Up to approximately 35 months
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