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

Phase 2

Not yet recruiting

• Conditions: Active Surveillance; Clear Cell Renal Cell Carcinoma
• Interventions: Drug: Belzutifan; Other: Active Surveillance

• Registration Number: NCT07023432
• Lead Sponsor: M.D. Anderson Cancer Center

Brief 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.

Study Timeline

• Status Verified: 2025-06
• Study First Submitted: 2025-06-10
• Study First Submitted QC: 2025-06-10
• Last Update Submitted: 2025-06-10
• Study First Posted: 2025-06-17
• Last Update Posted: 2025-06-17
• Study Start: 2025-12-03
• Primary Completion: 2028-04-14
• Study Completion: 2030-04-14

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 78

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Treatment group	Belzutifan	Participants will take belzutifan by mouth every day during the study. You will be given a dosing diary to write down when you take each dose of belzutifan, including if you miss or vomit any doses. Bring the diary with you to each visit, along with any leftover study drug and/or study drug bottles.
Observation group	Active Surveillance	Participants will not receive treatment in this study. Instead, you will undergo active surveillance under the discretion of your treating physician.

Primary Outcome Measures

Name	Time	Method
Safety and adverse events (AEs)	Through study completion; an average of 1 year	Incidence of Adverse Events, Graded According to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version (v) 5.0

Trial Locations

Locations (1)

MD Anderson Cancer Center; 🇺🇸 Houston, Texas, United States