MK-6598 + Pembrolizumab for Advanced or Metastatic Solid Tumors

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Advanced or Metastatic Solid TumorsPembrolizumab - Biological
Eligibility
18+
All Sexes
What conditions do you have?
Select

Study 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.

Eligible Conditions
  • Advanced or Metastatic Solid Tumors

Treatment Effectiveness

Study Objectives

3 Primary · 4 Secondary · Reporting Duration: Up to approximately 27 months

Day 2
Maximum Serum Concentration (Cmax) of MK-6598
Minimum Serum Concentration (Cmin) of MK-6598
Tumor Phenylpyruvate Concentrations
Day 2
Area Under the Curve (AUC) of MK-6598
Day 21
Number of Participants with a Dose-Limiting Toxicity (DLT) Graded Using National Cancer Institute Common Terminology Criteria for Adverse Events (AEs) Version 5.0
Month 24
Number of Participants Who Discontinue Study Treatment Due to an AE
Month 27
Number of Participants Who Experience At Least One AE

Trial Safety

Trial Design

2 Treatment Groups

MK-6598 + Pembrolizumab
1 of 2
MK-6598
1 of 2

Experimental Treatment

90 Total Participants · 2 Treatment Groups

Primary Treatment: MK-6598 + Pembrolizumab · No Placebo Group · Phase 1

MK-6598 + PembrolizumabExperimental Group · 2 Interventions: Pembrolizumab, MK-6598 · Intervention Types: Biological, Drug
MK-6598
Drug
Experimental Group · 1 Intervention: MK-6598 · Intervention Types: Drug
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Pembrolizumab
2017
Completed Phase 3
~2240

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: up to approximately 27 months

Who is running the clinical trial?

Merck Sharp & Dohme LLCLead Sponsor
3,673 Previous Clinical Trials
4,958,814 Total Patients Enrolled
3 Trials studying Advanced or Metastatic Solid Tumors
273 Patients Enrolled for Advanced or Metastatic Solid Tumors
Medical DirectorStudy DirectorMerck Sharp & Dohme LLC
2,635 Previous Clinical Trials
7,941,137 Total Patients Enrolled
2 Trials studying Advanced or Metastatic Solid Tumors
142 Patients Enrolled for Advanced or Metastatic Solid Tumors

Eligibility Criteria

Age 18+ · All Participants · 7 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
You have a histologically- or cytologically-confirmed advanced/metastatic solid tumor by pathology report and have received, or been intolerant to, all treatment known to confer clinical benefit.
This criterion is met if there is measurable disease by RECIST 1.
You have one or more discrete malignant lesions that are amenable to a minimum of 2 separate biopsies.
You are a male participant who receives MK-6598 and must agree to use contraception and should refrain from donating sperm during the specified period(s) of at least 102 days after study interventions.