Substudy 03B: A Study of Immune and Targeted Combination Therapies in Participants With Second Line Plus (2L+) Renal Cell Carcinoma (MK-3475-03B/KEYMAKER-U03)

Part of paid clinical trials in San Francisco, California.

Sponsor
Merck Sharp & Dohme LLC
Study ID
NCT04626518
Phase
PHASE1/PHASE2
Status
Active Not Recruiting

Conditions

  • Carcinoma, Renal Cell

Eligibility Criteria

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

Interventions

  • Pembrolizumab — BIOLOGICAL
    Administered via IV infusion at a dose of 200 mg Q3W or 400 mg Q6W
  • MK-4830 — BIOLOGICAL
    Administered via IV infusion at a dose of 800 mg Q3W
  • Belzutifan — DRUG
    Administered via oral tablet at a dose of 120 mg QD
  • Lenvatinib — DRUG
    Administered via oral capsule at a dose of 20 mg QD
  • Pembrolizumab/Quavonlimab — BIOLOGICAL
    Administered via IV infusion at a dose of 400 mg/25 mg Q6W
  • Favezelimab/Pembrolizumab — BIOLOGICAL
    Administered via IV infusion at a dose of 800 mg/200 mg Q3W

Study Details

Substudy 03B is part of a larger research study that is testing experimental treatments for renal cell carcinoma (RCC). The larger study is the umbrella study (U03). The goal of substudy 03B is to evaluate the safety and efficacy of experimental combinations of investigational agents in participants with advanced second line plus (2L+) clear cell renal cell carcinoma (ccRCC). This substudy will have two phases: a safety lead-in phase and an efficacy phase. The safety lead-in phase will be used to demonstrate a tolerable safety profile for the combination of investigational agents. There will be no hypothesis testing in this study.

Key Dates

First listed
Nov 12, 2020
Start date
Dec 17, 2020
Status verified
Apr 2026
Primary completion
Jul 17, 2026
Completion
Jul 17, 2026

Study Design

Enrollment
370 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Coformulation Pembrolizumab/Quavonlimab
    Participants will receive pembrolizumab/quavonlimab (coformulation of pembrolizumab 400 mg and quavonlimab 25 mg). Pembrolizumab/quavonlimab will be administered intravenously (IV) once every 6 weeks (Q6W) for up to 17 administrations (up to \~2 years).
  • Experimental: Coformulation Favezelimab/Pembrolizumab
    Participants will receive favezelimab/pembrolizumab (coformulation of favezelimab 800 mg and pembrolizumab 200 mg). Favezelimab/Pembrolizumab will be administered IV once every 3 weeks (Q3W) for up to 35 administrations (up to \~2 years).
  • Experimental: Pembrolizumab + MK-4830
    Participants will receive pembrolizumab 200 mg PLUS MK-4830 800 mg. Both pembrolizumab and MK-4830 will be administered IV Q3W for up to 35 administrations (up to \~2 years).
  • Experimental: Pembrolizumab + Belzutifan
    Participants will receive pembrolizumab 400 mg PLUS belzutifan 120 mg. Pembrolizumab will be administered IV Q6W for up to 17 administrations (up to \~ 2 years). Belzutifan will be administered orally once-daily (QD) until progressive disease or discontinuation.
  • Experimental: Belzutifan + Lenvatinib
    Participants will receive Belzutifan 120 mg PLUS lenvatinib 20 mg. Both belzutifan and lenvatinib will be administered orally QD until progressive disease or discontinuation.
  • Experimental: Pembrolizumab + Lenvatinib
    Participants will receive pembrolizumab 400 mg PLUS lenvatinib 20 mg. Pembrolizumab will be administered IV Q6W for up to 17 administrations (up to \~2 years). Lenvatinib will be administered orally QD until progressive disease or discontinuation.

Primary Outcome Measure

Safety Lead-in Phase: Number of participants who experience one or more dose-limiting toxicities (DLTs) [ Time Frame: Up to ~21 days ]

Locations (11)

FacilityCityStateZIPSite coordinators
University of California at San Francisco ( Site 3008)San FranciscoCalifornia94158-
Yale-New Haven Hospital-Yale Cancer Center ( Site 3011)New HavenConnecticut06510-
University of Chicago ( Site 3013)ChicagoIllinois60637-
University of Iowa ( Site 3012)Iowa CityIowa52242-
Henry Ford Health System ( Site 3014)DetroitMichigan48202-
Laura and Isaac Perlmutter Cancer Center ( Site 3016)New YorkNew York10016-
Memorial Sloan Kettering Cancer Center ( Site 3002)New YorkNew York10065-
Duke Cancer Institute ( Site 3015)DurhamNorth Carolina27710-
UPMC Cancer Center/Hillman Cancer Center ( Site 3017)PittsburghPennsylvania15232-
Vanderbilt University Medical Center ( Site 3004)NashvilleTennessee37232-
UTSW Medical Center ( Site 3003)DallasTexas75390-

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By research site
University of California at San Francisco· San Francisco, CAYale-New Haven Hospital-Yale Cancer Center· New Haven, CTUniversity of Chicago· Chicago, ILUniversity of Iowa· Iowa City, IAHenry Ford Health System· Detroit, MILaura and Isaac Perlmutter Cancer Center· New York, NY

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