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BRAVE-RCC: Belzutifan vs Active Surveillance in Indolent Metastatic Clear Cell Renal Cell Carcinoma
NCT07023432Phase 2
Key facts
- Status
- Recruiting
- Start
- Nov 2025
- Primary completion
- Apr 2028
- Countries
- 1
- Sponsor
- University of Texas MD Anderson Cancer Center
- Modality
- Small Molecules
- Drugs
- belzutifan
- Conditions
- clear cell renal cell carcinoma (ccRCC)
01
Overview
Phase 2, randomised, open-label trial of belzutifan in clear cell renal cell carcinoma (ccRCC) (2 arms), sponsored by University of Texas MD Anderson Cancer Center. Primary endpoints: Progression-Free Survival and Safety and adverse events (AEs) at 1 year. Started Nov 2025; status: recruiting.
02
Design
2 arms- Study design
- RandomizedOpen-label
Treatment group
Belzutifan by mouth every day
Observation group
Active surveillance
03
Who it enrols
Adults with metastatic clear cell renal cell carcinoma clinically apparent for <12 months, IMDC risk score 0 or 1, no prior systemic treatment for ccRCC, measurable disease, KPS >= 70% and ECOG 0-1, suitable for active surveillance, adequate organ function. Excludes brain metastases, need for supplemental oxygen, GI impairment, recent cardiovascular events, moderate/severe hepatic impairment, and active infections.
04
Endpoints
Primary
Progression-Free Survival
Safety and adverse events (AEs)
Secondary
Time to start of new systemic treatment
Objective Response Rate
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