NCT06460961

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

• Status: Active Not Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 168 (estimated)
• Sponsor: Merck Sharp & Dohme LLC · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Neoplasm Metastasis

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2024-07-14
• Primary completion: 2027-07-13
• Completion: 2027-07-13
• First posted: 2024-06-14
• Last updated: 2025-12-31

Locations

7 sites across 4 countries: United States, Australia, Canada, Israel

Regulatory

• FDA-regulated drug study