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BRAVE-RCC: Belzutifan for Metastatic Clear Cell Kidney Cancer

This study, BRAVE-RCC, is looking at whether the drug belzutifan can help people with metastatic clear cell renal cell carcinoma (a type of kidney cancer that has spread) who are currently being watched closely (active surveillance) and haven't had prior treatment. The study will compare belzutifan to active surveillance alone. Researchers want to see if belzutifan can control the cancer's progression and how safe it is. You might be able to join if you are at least 18 years old, have metastatic clear cell kidney cancer diagnosed within the last 12 months, and have not received previous systemic treatment for it. The main goal is to see if belzutifan can prevent the cancer from getting worse.

Study design
This interventional study plans to enroll 78 participants. It compares belzutifan given by mouth to active surveillance (observation).
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
Your safety and side effects will be monitored throughout the study, which is expected to average 1 year.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT07023432

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

Recruiting
PHASE2Ages 18+InterventionalTreatment
M.D. Anderson Cancer Center
~78 participants
Updated 2026-05-22 on ClinicalTrials.gov
What's tested:BelzutifanActive Surveillance

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Safety and adverse events (AEs)
Measured over Through study completion; an average of 1 year

Conditions

Active Surveillance
Clear Cell Renal Cell Carcinoma

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Clear Cell Renal Cell Carcinoma

NCT07023432

Where you'd take part

This study runs at 1 site. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.

  • MD Anderson Cancer Center

    Houston, Texasstudy coordinator listed

    Recruiting

Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.

Study leadership

  • Eric Jonasch, MD · PRINCIPAL_INVESTIGATOR · M.D. Anderson Cancer Center

Who to contact

Eric Jonasch, MD
[email protected]
713-563-7232
Email the study team

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Eligibility criteria

Inclusion

Is not a woman of child-bearing potential (WOCBP) OR
Is a WOCBP and using a contraceptive method that is highly effective (with a failure rate of \<1% per year), with low user dependency, or be abstinent from heterosexual intercourse as their preferred and usual lifestyle (abstinent on a long term and persistent basis), during the intervention period and for at least 30 days after the last dose of study intervention. The investigator should evaluate the potential for contraceptive method failure (ie, noncompliance, recently initiated) in relationship to the first dose of study intervention.
A WOCBP must have a negative highly sensitive pregnancy test (urine or serum as required by local regulations) within 24 hours before the first dose of study intervention.
If a urine test cannot be confirmed as negative (eg, an ambiguous result), a serum pregnancy test is required. In such cases, the participant must be excluded from participation if the serum pregnancy result is positive.
The investigator is responsible for review of medical history, menstrual history, and recent sexual activity to decrease the risk for inclusion of a woman with an early undetected pregnancy.
Contraceptive use by women should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies. 14. Male participants are eligible to participate if they agree to the following during the intervention period and for at least 7 days after the last dose of study intervention:
Be abstinent from heterosexual intercourse as their preferred and usual lifestyle (abstinent on a long term and persistent basis) and agree to remain abstinent OR
Must agree to use contraception unless confirmed to be azoospermic (vasectomized or secondary to medical cause as detailed below:
Agree to use a male condom plus partner use of an additional contraceptive method when having penile-vaginal intercourse with a WOCBP who is not currently pregnant. Note: Men with a pregnant or breastfeeding partner must agree to remain abstinent from penile-vaginal intercourse or use a male condom during each episode of penile-vaginal penetration.
Male participants must also agree to use male condom when engaging in any activity that allows for passage of ejaculate to another person of any sex.
Contraceptive use by men should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies. 15. Participants with a prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or efficacy assessment of the investigational regimen are eligible for this trial.

What this trial measures

  • 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