A Phase I Open-label, Multicenter Study of MK-6837 as Monotherapy and Combination Therapy in Participants With Advanced/Metastatic Solid Tumors

Study Identifier:
MK-6837-001
CT.gov Identifier:
NCT06460961
EudraCT Identifier:
N/A
EU Trial (CTIS) Number:
N/A
Study Contact Information:
(210) 593-5651 or [email protected]
Recruitment Complete

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Study 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.

Medical Condition
The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.
  • Metastatic Cancer
    • Phase
    The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
    I
    Sex
    Female & Male
    Age
    18+ years
    Study Drug
  • Drug: Experimental: Arm 1
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  • Drug: Experimental: Arm 2
  • Drug: Intervention/treatment:
  • Drug: Biological: Pembrolizumab
  • Drug: Drug: Rescue Medications
    • Study Status
    Indicates the current recruitment status or the expanded access status
    Recruitment Complete

    Requirements information
    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

    Clinical Study Information for Healthcare Providers

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    Study Locations

    Location
    Investigator
    Status
    Condition(s) Treated at Site
    Location
    START San Antonio
    San Antonio, TX, United States, 78229
    Investigator
    Drew Rasco
    Status
    Recruiting
    Condition(s) Treated at Site
    Metastatic Cancer