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ACTIVE NOT RECRUITING
NCT06460961
PHASE1

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

Sponsor: Merck Sharp & Dohme LLC

View on ClinicalTrials.gov

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.

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

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

168

Start Date

2024-07-14

Completion Date

2027-07-13

Last Updated

2025-12-31

Healthy Volunteers

No

Interventions

BIOLOGICAL

MK-6837

IV Infusion

BIOLOGICAL

Pembrolizumab

IV Infusion

DRUG

Rescue Medications

Antihistamine, H2 receptor antagonist, acetaminophen (or equivalent), dexamethasone (or equivalent) administered per product label prior to MK-6837.

Locations (7)

Atlantic Health System Morristown Medical Center ( Site 4001)

Morristown, New Jersey, United States

Providence Portland Medical Center ( Site 4002)

Portland, Oregon, United States

South Texas Accelerated Research Therapeutics (START) ( Site 4003)

San Antonio, Texas, United States

Westmead Hospital ( Site 1002)

Westmead, New South Wales, Australia

The Alfred Hospital ( Site 1001)

Melbourne, Victoria, Australia

Princess Margaret Cancer Centre ( Site 2001)

Toronto, Ontario, Canada

Sheba Medical Center-ONCOLOGY ( Site 3001)

Ramat Gan, Israel