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

Part of paid clinical trials in Sioux Falls, South Dakota.

Sponsor
Merck Sharp & Dohme LLC
Study ID
NCT05594043
Phase
PHASE1
Status
Completed

Conditions

  • Advanced or Metastatic Solid Tumors

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • MK-6598 — DRUG
    Oral tablet
  • Pembrolizumab — BIOLOGICAL
    Intravenous (IV) infusion

Study Details

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.

Key Dates

First listed
Oct 26, 2022
Start date
Dec 21, 2022
Status verified
Jun 2026
Primary completion
May 21, 2025
Completion
May 21, 2025

Study Design

Enrollment
39 participants (actual)
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Experimental: MK-6598
    Participants received MK-6598 daily (QD) between 50-500 mg for up to a total of 35 cycles (up to approximately 24 months). Participants were allowed at the investigator's discretion and after consultation with the Sponsor, to cross over to receive combination treatment of MK-6598 and Pembrolizumab
  • Experimental: MK-6598 + Pembrolizumab
    QD between 50-250 mg, plus pembrolizumab 200 mg once every 21-day cycle for up to 35 cycles (up to approximately 24 months).

Primary Outcome Measure

Number of Participants With a Dose-Limiting Toxicity (DLT) Graded Using National Cancer Institute Common Terminology Criteria for Adverse Events (AEs) Version 5.0 [ Time Frame: Up to approximately 21 days ]

Locations (1)

FacilityCityStateZIPSite coordinators
Sanford Cancer Center ( Site 0300)Sioux FallsSouth Dakota57104-

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By research site
Sanford Cancer Center· Sioux Falls, SD

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