A Study of MK-6837 as a Monotherapy and Combination Therapy in Participants With Advanced/Metastatic Solid Tumors (MK-6837-001)

Part of paid clinical trials in Morristown, New Jersey.

Sponsor
Merck Sharp & Dohme LLC
Study ID
NCT06460961
Phase
PHASE1
Status
Completed

Conditions

  • Neoplasm Metastasis

Eligibility Criteria

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

Interventions

  • MK-6837 — BIOLOGICAL
    IV Infusion
  • Pembrolizumab — BIOLOGICAL
    IV Infusion
  • Rescue Medications — DRUG
    Antihistamine, H2 receptor antagonist, acetaminophen (or equivalent), dexamethasone (or equivalent) administered per product label prior to MK-6837.

Study Details

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.

Key Dates

First listed
Jun 14, 2024
Start date
Jul 14, 2024
Status verified
Aug 2026
Primary completion
Jul 29, 2026
Completion
Jul 29, 2026

Study Design

Enrollment
40 participants (actual)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Arm 1: MK-6837 Monotherapy
    Participants receive escalating doses of MK-6837 via intravenous (IV) infusion once every 3 weeks (Q3W) (Day 1 of every 21-day cycle) until progressive disease or discontinuation.
  • Experimental: Arm 2: MK-6837 + Pembrolizumab Combination Therapy
    Participants receive escalating doses of MK-6837 via IV infusion Q3W (Day 1 of every 21-day cycle) until progressive disease or discontinuation PLUS 200mg of pembrolizumab via IV infusion Q3W (Day 1 of every 21-day cycle) for up to 35 administrations (up to \~2 years).

Primary Outcome Measure

Number of participants who experience one or more dose-limiting toxicities (DLTs) [ Time Frame: Cycle 1 (Up to approximately 21 days); each cycle is 21 days. ]

Locations (3)

FacilityCityStateZIPSite coordinators
Atlantic Health System Morristown Medical Center ( Site 4001)MorristownNew Jersey07960-
Providence Portland Medical Center ( Site 4002)PortlandOregon97213-
South Texas Accelerated Research Therapeutics (START) ( Site 4003)San AntonioTexas78229-

Find similar trials in Morristown, NJ

By research site
Atlantic Health System Morristown Medical Center· Morristown, NJProvidence Portland Medical Center· Portland, ORSouth Texas Accelerated Research Therapeutics (START)· San Antonio, TX

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