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

Part of paid clinical trials in Houston, Texas.

Sponsor
M.D. Anderson Cancer Center
Study ID
NCT07023432
Phase
PHASE2
Status
Recruiting
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Conditions

  • Active Surveillance
  • Clear Cell Renal Cell Carcinoma

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Belzutifan — DRUG
    Given by PO
  • Active Surveillance — OTHER
    Given by Observation

Study Details

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.

Key Dates

Start date
Nov 17, 2025
Status verified
May 2026
Primary completion
Apr 14, 2028
Completion
Apr 14, 2030

Study Design

Enrollment
78 participants (estimated)
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Treatment group
    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.
  • Experimental: Observation group
    Participants will not receive treatment in this study. Instead, you will undergo active surveillance under the discretion of your treating physician.

Primary Outcome Measure

Safety and adverse events (AEs) [ Time Frame: Through study completion; an average of 1 year ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
MD Anderson Cancer CenterHoustonTexas77030
Eric Jonasch, MD
[email protected]
713-563-7232
Eric Jonasch, MD (PRINCIPAL_INVESTIGATOR)

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By research site
MD Anderson Cancer Center· Houston, TX

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