NCT05594043

A Study of MK-6598 as Monotherapy and in Combination With Pembrolizumab (MK-3475) in Advanced Solid Tumors (MK-6598-001)

A Phase 1, Open-label, Multicenter Study to Assess Safety, Tolerability, PK, and Efficacy of MK-6598 as Monotherapy and in Combination With Pembrolizumab in Participants With Advanced Solid Tumors

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 90 (actual)
• Sponsor: Merck Sharp & Dohme LLC · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to assess the efficacy and safety and establish a preliminary recommended Phase 2 dose (RP2D) of MK-6598 administered as monotherapy and in combination with pembrolizumab (MK-3475) in adult participants with advanced or metastatic solid tumors.

Conditions

• Advanced or Metastatic Solid Tumors

Interventions

Type	Name	Description
DRUG	MK-6598	Oral tablet
BIOLOGICAL	Pembrolizumab	Intravenous (IV) infusion

Timeline

• Start date: 2022-12-21
• Primary completion: 2025-05-21
• Completion: 2025-05-21
• First posted: 2022-10-26
• Last updated: 2025-06-19

Locations

6 sites across 3 countries: United States, Canada, Switzerland

Regulatory

• FDA-regulated drug study