BENITIONSClinical Trial Intelligence

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

Phase 1 Completed NCT05594043

ConditionAdvanced or Metastatic Solid Tumors
PhasePhase 1
SponsorMerck Sharp & Dohme LLC
StatusCompleted
Enrollment39 participants
InterventionsMK-6598, Pembrolizumab
Start dateDec 21, 2022
Completion dateMay 21, 2025
Results postedJul 15, 2026

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.

Number of Participants With a Dose-Limiting Toxicity (DLT) Graded Using National Cancer Institute Common Terminology Criteria for Adverse Events (AEs) Version 5.0

Up to approximately 21 days · Participants

50 mg MK-65980 Participants
125 mg MK-65980 Participants
250 mg MK-65980 Participants
500 mg MK-65980 Participants
50 mg MK-6598 + Pembrolizumab1 Participants
125 mg MK-6598 + Pembrolizumab0 Participants

Number of Participants Who Experienced At Least One AE

Up to approximately 24 months · Participants

50 mg MK-65984 Participants
125 mg MK-65983 Participants
250 mg MK-65983 Participants
500 mg MK-65989 Participants
50 mg MK-6598 + Pembrolizumab7 Participants
125 mg MK-6598 + Pembrolizumab6 Participants

Number of Participants Who Discontinue Study Treatment Due to an AE

Up to approximately 24 months · Participants

50 mg MK-65980 Participants
125 mg MK-65981 Participants
250 mg MK-65980 Participants
500 mg MK-65981 Participants
50 mg MK-6598 + Pembrolizumab0 Participants
125 mg MK-6598 + Pembrolizumab1 Participants

Open in BENITIONS View on ClinicalTrials.gov

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