ACTIVE_NOT_RECRUITING

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

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Conditions

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

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2024-07-14
Study Completion:2027-07-13
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:ACTIVE_NOT_RECRUITING

Study ID

NCT06460961

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.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Histologically or cytologically confirmed solid tumor by pathology report that is advanced or metastatic
  2. * Human Immunodeficiency Virus (HIV)-infected participants must have well controlled HIV on Antiretroviral Therapy (ART)
  3. * 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
  4. * Participants with history of Hepatitis C Virus (HCV) infection are eligible if HCV viral load is undetectable at screening
  1. * 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
  2. * History of a second malignancy, unless potentially curative treatment has been completed with no evidence of malignancy for 2 years
  3. * Has clinically significant cardiovascular disease
  4. * HIV-infected participants with a history of Kaposi's sarcoma and/or Multicentric Castleman's Disease
  5. * Received prior systemic anticancer therapy including investigational agents within 4 weeks before the first dose of study intervention
  6. * 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
  7. * Received prior radiotherapy within 2 weeks of start of study intervention, or has radiation-related toxicities, requiring corticosteroids
  8. * Received a live or live-attenuated vaccine within 30 days before the first dose of study intervention. Administration of killed vaccines is allowed
  9. * 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
  10. * Known additional malignancy that is progressing or has required active treatment within the past 2 years
  11. * Known active Central Nervous System (CNS) metastases and/or carcinomatous meningitis
  12. * Active autoimmune disease that has required systemic treatment in the past 2 years except replacement therapy
  13. * History of (noninfectious) pneumonitis/interstitial lung disease that required steroids or has current pneumonitis/interstitial lung disease
  14. * Active infection requiring systemic therapy
  15. * History of allogeneic tissue/solid organ transplant
  16. * Participants who have not adequately recovered from major surgery or have ongoing surgical complications

Contacts and Locations

Principal Investigator

Medical Director
STUDY_DIRECTOR
Merck Sharp & Dohme LLC

Study Locations (Sites)

Atlantic Health System Morristown Medical Center ( Site 4001)
Morristown, New Jersey, 07960
United States
Providence Portland Medical Center ( Site 4002)
Portland, Oregon, 97213
United States
South Texas Accelerated Research Therapeutics (START) ( Site 4003)
San Antonio, Texas, 78229
United States

Collaborators and Investigators

Sponsor: Merck Sharp & Dohme LLC

  • Medical Director, STUDY_DIRECTOR, Merck Sharp & Dohme LLC

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-07-14
Study Completion Date2027-07-13

Study Record Updates

Study Start Date2024-07-14
Study Completion Date2027-07-13

Terms related to this study

Keywords Provided by Researchers

  • 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)

Additional Relevant MeSH Terms

  • Neoplasm Metastasis