Substudy 03C: A Study of Combination Therapies in Participants With Renal Cell Carcinoma With Recurrent Disease During or After Anti-PD-(L)1 Therapy (MK-3475-03C/KEYMAKER-U03)

Part of paid clinical trials in San Francisco, California.

Sponsor
Merck Sharp & Dohme LLC
Study ID
NCT07049926
Phase
PHASE1/PHASE2
Status
Recruiting
Apply to this trial

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 120 Years
Healthy Volunteers
Not accepted

Interventions

  • Belzutifan — DRUG
    Oral Tablet
  • Zanzalintinib — DRUG
    Oral Tablet

Study Details

Substudy 03C 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 03C is to evaluate the safety and efficacy of experimental combinations of investigational agents in participants with clear cell renal cell carcinoma (ccRCC) who have recurrent disease during or after anti-programmed cell death 1/programmed cell death ligand 1 (PD-\[L\]1) adjuvant therapy. 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

Start date
Jul 20, 2025
Status verified
May 2026
Primary completion
Oct 26, 2031
Completion
Oct 26, 2031

Study Design

Enrollment
140 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Zanzalintinib at Dose Level 1 or 2 + Belzutifan
    Participants will be allocated to receive zanzalintinib at dose level 1 or 2 + belzutifan daily until progressive disease or discontinuation
  • Experimental: Belzutifan
    Participants will receive belzutifan daily 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 approximately 21 days ]

Central Contacts

Locations (7)

FacilityCityStateZIPSite coordinators
UCSF Medical Center at Mission Bay ( Site 5008)San FranciscoCalifornia94158
Study Coordinator
415-694-3896
Perlmutter Cancer Center at NYU Langone Hospital - Long Island ( Site 5026)MineolaNew York11501
Study Coordinator
516-663-3696
Laura and Isaac Perlmutter Cancer Center ( Site 5016)New YorkNew York10016
Study Coordinator
212-731-6000
Memorial Sloan Kettering Cancer Center ( Site 5002)New YorkNew York10065
Study Coordinator
212-639-2000
Duke Cancer Institute ( Site 5015)DurhamNorth Carolina27710
Study Coordinator
919-681-1030
UPMC Cancer Center/Hillman Cancer Center ( Site 5017)PittsburghPennsylvania15232
Study Coordinator
412-864-6600
Vanderbilt University Medical Center ( Site 5004)NashvilleTennessee37232
Study Coordinator
615-343-2882

Find similar trials in San Francisco, CA

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By research site
UCSF Medical Center at Mission Bay· San Francisco, CAPerlmutter Cancer Center at NYU Langone Hospital - Long Island· Mineola, NYLaura and Isaac Perlmutter Cancer Center· New York, NYMemorial Sloan Kettering Cancer Center· New York, NYDuke Cancer Institute· Durham, NCUPMC Cancer Center/Hillman Cancer Center· Pittsburgh, PA

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