A Study of MK-6837 as a Monotherapy and Combination Thera... | NCT06460961

ID	Type	Description	Link
MK-6837-001	Other Identifier	MSD

Status Module

Description Module

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Arm 1: MK-6837 Monotherapy	Experimental	Participants receive escalating doses of MK-6837 via intravenous (IV) infusion once every 3 weeks (Q3W) (Day 1 of every 21-day cycle) until progressive disease or discontinuation.	Biological: MK-6837 Drug: Rescue Medications
Arm 2: MK-6837 + Pembrolizumab Combination Therapy	Experimental	Participants receive escalating doses of MK-6837 via IV infusion Q3W (Day 1 of every 21-day cycle) until progressive disease or discontinuation PLUS 200mg of pembrolizumab via IV infusion Q3W (Day 1 of every 21-day cycle) for up to 35 administrations (up to ~2 years).	Biological: MK-6837 Biological: Pembrolizumab Drug: Rescue Medications

Name	Type	Description	Arm Group Labels	Other Names
MK-6837	Biological	IV Infusion	Arm 1: MK-6837 Monotherapy Arm 2: MK-6837 + Pembrolizumab Combination Therapy

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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.	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.	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.	Up to approximately 35 months

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

The main inclusion criteria include but are not limited to the following:

Histologically or cytologically confirmed solid tumor by pathology report that is advanced or metastatic
Human Immunodeficiency Virus (HIV)-infected participants must have well controlled HIV on Antiretroviral Therapy (ART)
Participants who are Hepatitis B Surface Antigen (HBsAg) positive are eligible if they have received Hepatitis B Virus (HBV) antiviral therapy for at least 4 weeks, and have undetectable HBV viral load before allocation
Participants with history of Hepatitis C Virus (HCV) infection are eligible if HCV viral load is undetectable at screening

Exclusion Criteria:

The main exclusion criteria include but are not limited to the following:

Has not recovered to Common Terminology Criteria for Adverse Events (CTCAE) Grade 1 or better from any Adverse Events (AEs) that were due to cancer therapeutics administered more than 4 weeks earlier
History of a second malignancy, unless potentially curative treatment has been completed with no evidence of malignancy for 2 years
Has clinically significant cardiovascular disease
HIV-infected participants with a history of Kaposi's sarcoma and/or Multicentric Castleman's Disease
Received prior systemic anticancer therapy including investigational agents within 4 weeks before the first dose of study intervention
Has received any prior immunotherapy and was discontinued from that treatment due to a Grade 3 or higher immune-related AE (except endocrine disorders that can be treated with replacement therapy) or was discontinued from that treatment due to Grade 2 myocarditis or recurrent Grade 2 pneumonitis
Received prior radiotherapy within 2 weeks of start of study intervention, or has radiation-related toxicities, requiring corticosteroids
Received a live or live-attenuated vaccine within 30 days before the first dose of study intervention. Administration of killed vaccines is allowed
Diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy or any other form of immunosuppressive therapy within 7 days before the first dose of study intervention
Known additional malignancy that is progressing or has required active treatment within the past 2 years
Known active Central Nervous System (CNS) metastases and/or carcinomatous meningitis
Active autoimmune disease that has required systemic treatment in the past 2 years except replacement therapy
History of (noninfectious) pneumonitis/interstitial lung disease that required steroids or has current pneumonitis/interstitial lung disease
Active infection requiring systemic therapy
History of allogeneic tissue/solid organ transplant
Participants who have not adequately recovered from major surgery or have ongoing surgical complications

ID	Term
D009362	Neoplasm Metastasis
C565324	Parkinson Disease 4, Autosomal Dominant Lewy Body

ID	Term
D009385	Neoplastic Processes
D009369	Neoplasms
D010335	Pathologic Processes
D013568	Pathological Conditions, Signs and Symptoms