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

Description

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.

Conditions

Neoplasm Metastasis

Study Overview

Study Details

Study overview

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.

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

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

Condition
Neoplasm Metastasis
Intervention / Treatment

-

Contacts and Locations

Morristown

Atlantic Health System Morristown Medical Center ( Site 4001), Morristown, New Jersey, United States, 07960

Portland

Providence Portland Medical Center ( Site 4002), Portland, Oregon, United States, 97213

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility Criteria

  • * 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
  • * 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

Ages Eligible for Study

18 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Merck Sharp & Dohme LLC,

Medical Director, STUDY_DIRECTOR, Merck Sharp & Dohme LLC

Study Record Dates

2029-07-13