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

Last updated: April 30, 2025
Sponsor: Merck Sharp & Dohme LLC
Overall Status: Active - Recruiting

Phase

1

Condition

Neoplasm Metastasis

Treatment

MK-6837

Pembrolizumab

Clinical Study ID

NCT06460961
6837-001
MK-6837-001
  • Ages > 18
  • All Genders

Study Summary

The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics (PK), 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

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

  • Histologically or cytologically confirmed solid tumor by pathology report that isadvanced or metastatic

  • Human Immunodeficiency Virus (HIV)-infected participants must have well controlledHIV on Antiretroviral Therapy (ART)

  • Participants who are Hepatitis B Surface Antigen (HBsAg) positive are eligible ifthey 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 HCVviral load is undetectable at screening

Exclusion

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 1or better from any Adverse Events (AEs) that were due to cancer therapeuticsadministered more than 4 weeks earlier

  • History of a second malignancy, unless potentially curative treatment has beencompleted 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 MulticentricCastleman's Disease

  • Received prior systemic anticancer therapy including investigational agents within 4weeks before the first dose of study intervention

  • Has received any prior immunotherapy and was discontinued from that treatment due toa Grade 3 or higher immune-related AE (except endocrine disorders that can betreated with replacement therapy) or was discontinued from that treatment due toGrade 2 myocarditis or recurrent Grade 2 pneumonitis

  • Received prior radiotherapy within 2 weeks of start of study intervention, or hasradiation-related toxicities, requiring corticosteroids

  • Received a live or live-attenuated vaccine within 30 days before the first dose ofstudy intervention. Administration of killed vaccines is allowed

  • Diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy orany other form of immunosuppressive therapy within 7 days before the first dose ofstudy intervention

  • Known additional malignancy that is progressing or has required active treatmentwithin 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 yearsexcept replacement therapy

  • History of (noninfectious) pneumonitis/interstitial lung disease that requiredsteroids 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 ongoingsurgical complications

Study Design

Total Participants: 100
Treatment Group(s): 2
Primary Treatment: MK-6837
Phase: 1
Study Start date:
July 14, 2024
Estimated Completion Date:
July 13, 2029

Connect with a study center

  • Westmead Hospital ( Site 1002)

    Westmead, New South Wales 2145
    Australia

    Active - Recruiting

  • The Alfred Hospital ( Site 1001)

    Melbourne, Victoria 3004
    Australia

    Active - Recruiting

  • Princess Margaret Cancer Centre ( Site 2001)

    Toronto, Ontario M5G 2M9
    Canada

    Active - Recruiting

  • Sheba Medical Center-ONCOLOGY ( Site 3001)

    Ramat Gan, 5265601
    Israel

    Active - Recruiting

  • Atlantic Health System Morristown Medical Center ( Site 4001)

    Morristown, New Jersey 07960
    United States

    Active - Recruiting

  • Providence Portland Medical Center ( Site 4002)

    Portland, Oregon 97213
    United States

    Active - Recruiting

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