NCT07023432

Belzutifan's Role in Active Surveillance Versus Treatment for Indolentmetastatic Clear Cell Renal Ccell Carcinoma (BRAVE-RCC)

• Status: Not Yet Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 78 (estimated)
• Sponsor: M.D. Anderson Cancer Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

To learn if belzutifan can help to control the disease in patients with metastatic RCC who are considered candidates for active surveillance and have not undergone previous systemic treatment. The safety of belzutifan in this patient population will also be studied.

Detailed description

Primary Objectives • To compare the progression-free survival difference for participants treated with belzutifan versus active surveillance as evaluated by RECIST 1.1 criteria. Secondary Objectives * To describe the safety profile of belzutifan in this population using CTCAE v5.0. * To estimate the difference in time to start of new systemic treatment in participants treated with belzutifan versus active surveillance. * To describe objective response rates (CR and PR) using RECIST 1.1 criteria. Exploratory Objectives * To describe methylated ctDNA characteristics for participants at baseline, during treatment, and at progression. * To describe baseline tissue-based gene expression profiling and its association with outcome where tissue is available. * To estimate differences in target lesion sum of diameters from baseline to start of next systemic therapy. * To estimate differences in quality of life based on FKSI-19 questionnaire for participants on belzutifan versus surveillance. * To describe PFS2 (time to second disease progression) in both arms. * To describe overall survival in both groups. * To describe the duration of objective response, duration of CR, and duration of SD using RECIST 1.1 criteria.

Conditions

• Active Surveillance
• Clear Cell Renal Cell Carcinoma

Interventions

Type	Name	Description
DRUG	Belzutifan	Given by PO
OTHER	Active Surveillance	Given by Observation

Timeline

• Start date: 2025-12-03
• Primary completion: 2028-04-14
• Completion: 2030-04-14
• First posted: 2025-06-17
• Last updated: 2025-06-17

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study