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NCT06460961CompletedPhase 1

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

A Phase 1 Open-label, Multicenter Study of MK-6837 as Monotherapy and Combination Therapy in Participants With Advanced/Metastatic Solid Tumors

Source: ClinicalTrials.gov · Last updated 28 Aug 2026

Brief summary (registry, in English)

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.

Status (registry)
Completed
Phase (registry)
Phase 1
Study type
Interventional
Enrollment
40 (actual)
First submitted
11 Jun 2024
Start date
14 Jul 2024
Primary completion date
29 Jul 2026
Lead sponsor
Merck Sharp & Dohme LLC
NCT number
NCT06460961

What you commit to

  • Study type: Interventional · Phase 1
  • Participants enrolled: 40
  • From 14 Jul 2024 to the primary completion date, 29 Jul 2026
  • 7 sites in 4 countries
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • 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
  • Participants who have not adequately recovered from major surgery or have ongoing surgical complications

Other illness

  • 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
  • Known additional malignancy that is progressing or has required active treatment within the past 2 years
  • 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

Other

  • The main exclusion criteria include but are not limited to the following:
  • Known active Central Nervous System (CNS) metastases and/or carcinomatous meningitis

Who the study is looking for

  • 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

Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (7)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
The Alfred Hospital ( Site 1001)
Coordinator of this site? Confirm its status
MelbourneAustraliaUnknown status
Westmead Hospital ( Site 1002)
Coordinator of this site? Confirm its status
WestmeadAustraliaUnknown status
Princess Margaret Cancer Centre ( Site 2001)
Coordinator of this site? Confirm its status
TorontoCanadaUnknown status
Sheba Medical Center-ONCOLOGY ( Site 3001)
Coordinator of this site? Confirm its status
Ramat GanIsraelUnknown status
Atlantic Health System Morristown Medical Center ( Site 4001)
Coordinator of this site? Confirm its status
MorristownUnited StatesUnknown status
Providence Portland Medical Center ( Site 4002)
Coordinator of this site? Confirm its status
PortlandUnited StatesUnknown status
South Texas Accelerated Research Therapeutics (START) ( Site 4003)
Coordinator of this site? Confirm its status
San AntonioUnited StatesUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.