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Study details
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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)

Merck Sharp & Dohme LLC
NCT IDNCT07049926ClinicalTrials.gov data as of Apr 2026
Phase

Phase 1/2

Target enrollment

140

Study length

about 6.3 years

Ages

18–120

Locations

6 sites in CA, NC, NY +1

What this study is about

This trial is testing a treatment combination of Belzutifan and Zanzalintinib for people with kidney cancer that has returned after other treatments. The goal is to see if this combination is safe and effective in people who have clear cell renal cell carcinoma (ccRCC) and recurrent disease during or after anti-PD-(L)1 therapy.

Simplified from trial records by PatientMatch.

What you may be asked to do

  • 1.Take Belzutifan
  • 2.Take Zanzalintinib

Participation Burden

What's physically and logistically required of participants.

Logistics & Travel
In-person visits

Requires travel to a study site

Physical Intervention
Oral

How treatment is administered

Treatment Assignment
All receive treatment

Everyone gets the investigational treatment.

Extracted study details

Pulled from the trial record to show what is being tested and what the study is measuring.

Drug classes

belzutifan

Drug routes

oral (Oral Tablet)

Endpoints

Primary: Efficacy Phase: Number of participants who discontinue study treatment due to an AE, Efficacy Phase: Number of participants who experience one or more AEs, Efficacy Phase: Objective Response Rate (ORR), Safety Lead In Phase: Number of participants who discontinue study treatment due to an AE, Safety Lead In Phase: Number of participants who experience one or more adverse events (AEs)

Secondary: Efficacy Phase: Duration of response (DOR), Efficacy Phase: Overall survival (OS), Efficacy Phase: Progression-free survival (PFS)

Body systems

Oncology