A Study of MK-6837 as a Monotherapy and Combination Therapy in Participants With Advanced/Metastatic Solid Tumors (MK-6837-001)

NCT06460961 | Active Not Recruiting Phase 1 FDA Drug

• 2 other identifiers: 6837-001MK-6837-001
• Study Type: interventional
• Target: 168
• Locations: 4 countries
• Sites: 7

Brief Summary

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.

Conditions

Neoplasm Metastasis

Keywords

Programmed Cell Death-1 (PD1, PD-1); Programmed Cell Death 1 Ligand 1 (PDL1, PD-L1); Programmed Cell Death 1 Ligand 2 (PDL2, PD-L2)

Outcome Measures

Primary Outcomes (3)

• 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

Study Arms (2)

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

Interventions

MK-6837 BIOLOGICAL

IV Infusion

Arm 1: MK-6837 Monotherapy; Arm 2: MK-6837 + Pembrolizumab Combination Therapy

Pembrolizumab BIOLOGICAL

IV Infusion

Also known as: MK-3475, KEYTRUDA®

Arm 2: MK-6837 + Pembrolizumab Combination Therapy

Rescue Medications DRUG

Antihistamine, H2 receptor antagonist, acetaminophen (or equivalent), dexamethasone (or equivalent) administered per product label prior to MK-6837.

Arm 1: MK-6837 Monotherapy; Arm 2: MK-6837 + Pembrolizumab Combination Therapy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Merck Sharp & Dohme LLC: lead

Study Sites (7)

Atlantic Health System Morristown Medical Center ( Site 4001)

Morristown, New Jersey, 07960, United States

Location

Providence Portland Medical Center ( Site 4002)

Portland, Oregon, 97213, United States

Location

South Texas Accelerated Research Therapeutics (START) ( Site 4003)

San Antonio, Texas, 78229, United States

Location

Westmead Hospital ( Site 1002)

Westmead, New South Wales, 2145, Australia

Location

The Alfred Hospital ( Site 1001)

Melbourne, Victoria, 3004, Australia

Location

Princess Margaret Cancer Centre ( Site 2001)

Toronto, Ontario, M5G 2M9, Canada

Location

Sheba Medical Center-ONCOLOGY ( Site 3001)

Ramat Gan, 5265601, Israel

Location

Related Links

• Merck Clinical Trials Information

MeSH Terms

Conditions

Neoplasm Metastasis; Parkinson Disease 4, Autosomal Dominant Lewy Body

Interventions

pembrolizumab

Condition Hierarchy (Ancestors)

Neoplastic Processes; Neoplasms; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Medical Director

  Merck Sharp & Dohme LLC

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 11, 2024
• First Posted: June 14, 2024
• Study Start: July 14, 2024
• Primary Completion (Estimated): July 13, 2027
• Study Completion (Estimated): July 13, 2027
• Last Updated: December 31, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will share

Locations

US (3); IL (1); AU (2); CA (1)