Active SurveillancePhase 2NCT07023432
Belzutifan's Role in Active Surveillance Versus Treatment for Indolentmetastatic Clear Cell Renal Ccell Carcinoma (BRAVE-RCC)
A Phase 2 study testing Belzutifan and Active Surveillance in people with Active Surveillance and Clear Cell Renal Cell Carcinoma, run by M.D. Anderson Cancer Center at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Active Surveillance, Clear Cell Renal Cell Carcinoma
- What is being tested?
- Belzutifan and Active Surveillance
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 78 participants
- Where
- 1 siteUnited States
- Study dates
- 17 Nov 2025to 14 Apr 2030
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Metastatic clear cell renal cell carcinoma, with or without sarcomatoid features, clinically apparent less than 12 months.
- Male/female participants must be at least 18 years of age on the day of signing informed consent.
- IMDC risk score of 0 or 1.
- No prior systemic treatment for ccRCC. Adjuvant immunotherapy or targeted treatments allowed if progressive disease is noted at least 12 months after last dose of immunotherapy.
- Metastatic disease that is documented by imaging with CT or MRI and measurable by RECIST1.1.
- Participants must have signed and dated an Institutional Review Board (IRB)/Institutional Ethics Committee (IEC) approved written informed consent form (ICF) in accordance with regulatory and institutional guidelines. This must be obtained before the performance of any protocol related procedures that are not part of normal participant care.
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- Karnofsky performance status ≥ 70% and ECOG PS 0 or 1
- Suitable for active surveillance in the medical judgment of the treating oncologist.
- Participants must have adequate organ and marrow function as defined below:
- absolute neutrophil count ≥ 1.5 x 109/L ii. platelets ≥ 100 x 109/L iii. hemoglobin (Hgb) ≥ 9 g/dL iv. total bilirubin ≤ 1.5 x Institutional upper limit of normal (ULN) v. AST(SGOT)/ALT(SGPT) ≤ 2.5 × institutional ULN vi. serum creatinine ≤ 1.5 × institutional ULN OR 24-hour clearance ≥ 40 mL/min
- Aspartate aminotransferase (serum glutamic-oxaloacetic transaminase)-AST(SCOT)/ Alanine aminotransferase (serum glutamic-pyruvic transaminase)- ALT(SGPT)
- A minimum of 28 days from any major surgery prior to registration.
- Ability to swallow, retain, and absorb oral medication.
- Baseline oxygen saturation >92% on room air.
- Female Participants are eligible to participate if she is not pregnant or breastfeeding, and at least one of the following conditions applies:
- 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.
- 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.
- 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.
Who cannot join
- Known or suspected brain metastases or active leptomeningeal disease.
- Requires any supplemental oxygen (either intermittent or chronic)
- Other concurrent severe and/or uncontrolled concomitant medical conditions (e.g., active or uncontrolled infection) that could cause unacceptable safety risks or compromise compliance with protocol
- Impairment of gastrointestinal function or disease that may significantly alter the absorption of belzutifan (e.g., uncontrolled nausea, vomiting, diarrhea, malabsorption syndromes, prior small bowel resection, or inflammatory bowel disease)
- Prior cardiovascular event including myocardial infarction, rest claudication, stroke, unstable angina, central nervous system (CNS) hemorrhage, unstable ventricular arrythmias, or severe congestive heart failure (NYHA Class 3 or higher) within the past 6 months
- Received colony-stimulating factors (eg, granulocyte colony stimulating factor, granulocytemacrophage colony stimulating factor or recombinant erythropoietin) ≤28 days prior to the first dose of study intervention.
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- Has moderate to severe hepatic impairment (Child-Pugh B or C).
- Participants who have undergone major surgery ≤ 28 days prior to starting study drug, radiation ≤ 2 weeks prior to starting study drug, or who have not recovered from side effects of such therapy prior to registration.
- Has received any type of small molecule kinase inhibitor (including investigational agents) ≤2 weeks before randomization; any prior HIF-2a antagonist exposure.
- Has known hypersensitivity or allergy to the active pharmaceutical ingredient or any component of the study intervention (belzutifan) formulations.
- Is currently receiving either strong (phenobarbital, enzalutamide, phenytoin, rifampicin, rifabutin, rifapentine, carbamazepine, nevirapine and St John's Wort) or moderate (eg, bosentan, efavirenz, modafinil) inducers of CYP3A4 that cannot be discontinued for the duration of the study.
- Active infection requiring systemic therapy within 14 days prior to treatment assignment.
- Has active tuberculosis.
- Active HBV (defined as HBsAg reactive and detectable HBV viral load) or active HCV (defined as HCV RNA [qualitative] is detected) infection.
- Has a history or current evidence of any condition, therapy, or laboratory abnormality or other circumstance that might confound the results of the study, interfere with the participant's participation for the full duration of the study, such that it is not in the best interest of the participant to participate, in the opinion of the treating investigator.
- Has uncontrolled HIV infection (history of HIV with CD4 count >400 and undetectable HIV viral load while on anti-retroviral therapy allowed).
- Pregnant women are excluded from this study. Women who are breastfeeding should discontinue prior to initiating treatment.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
MD Anderson Cancer Center
Houston, Texas, 77030
Eric Jonasch, MD, 713-563-7232, ejonasch@mdanderson.org
Eric Jonasch, MD
About this study
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.
Read the 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.
- Being tested
- Belzutifan, Active Surveillance
- Medical subject headings
- Carcinoma, Renal Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BelzutifanDrug
Given by PO
Active SurveillanceOther
Given by Observation
| Study group | Role | What they receive |
|---|---|---|
| Treatment group | Experimental | 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. Receives: Drug: Belzutifan |
| Observation group | Experimental | Participants will not receive treatment in this study. Instead, you will undergo active surveillance under the discretion of your treating physician. Receives: Other: Active Surveillance |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety and adverse events (AEs)
Incidence of Adverse Events, Graded According to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version (v) 5.0
Measured: Through study completion; an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jun 2025
- Study start17 Nov 2025
- Primary completion14 Apr 2028 (estimated)
- Study completion14 Apr 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Active SurveillanceStudies of the same condition, open and under way.
- More trials run by M.D. Anderson Cancer CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 78 participants (estimated)
Sponsor and investigators
- Lead sponsor
- M.D. Anderson Cancer Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Eric Jonasch, MD, Principal investigator, M.D. Anderson Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07023432
- Sponsor's protocol ID
- 2025-0268
- Other IDs
- NCI-2025-04261
- Status last verified
- May 2026
- First submitted
- 10 Jun 2025
- Last updated
- 22 May 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Belzutifan's Role in Active Surveillance Versus Treatment for Indolentmetastatic Clear Cell Renal Ccell Carcinoma (BRAVE-RCC)
- ClinicalTrials.gov ID
- NCT07023432
- Acronym / sponsor ID
- 2025-0268
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 78 participants (estimated)
- Lead sponsor
- M.D. Anderson Cancer CenterUniversity, hospital or other
- Study start
- 17 Nov 2025 (actual)
- Primary completion
- 14 Apr 2028 (estimated)
- Study completion
- 14 Apr 2030 (estimated)
- First posted
- 17 Jun 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Treatment group | Experimental | Drug: BelzutifanParticipants 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 | Experimental | Other: Active SurveillanceParticipants will not receive treatment in this study. Instead, you will undergo active surveillance under the discretion of your treating physician. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (28 listed)
- Metastatic clear cell renal cell carcinoma, with or without sarcomatoid features, clinically apparent less than 12 months.
- Male/female participants must be at least 18 years of age on the day of signing informed consent.
- IMDC risk score of 0 or 1.
- No prior systemic treatment for ccRCC. Adjuvant immunotherapy or targeted treatments allowed if progressive disease is noted at least 12 months after last dose of immunotherapy.
- Metastatic disease that is documented by imaging with CT or MRI and measurable by RECIST1.1.
Key exclusion criteria (17 listed)
- Known or suspected brain metastases or active leptomeningeal disease.
- Requires any supplemental oxygen (either intermittent or chronic)
- Other concurrent severe and/or uncontrolled concomitant medical conditions (e.g., active or uncontrolled infection) that could cause unacceptable safety risks or compromise compliance with protocol
- Impairment of gastrointestinal function or disease that may significantly alter the absorption of belzutifan (e.g., uncontrolled nausea, vomiting, diarrhea, malabsorption syndromes, prior small bowel resection, or inflammatory bowel disease)
- Prior cardiovascular event including myocardial infarction, rest claudication, stroke, unstable angina, central nervous system (CNS) hemorrhage, unstable ventricular arrythmias, or severe congestive heart failure (NYHA Class 3 or higher) within the past 6 months
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BelzutifanGiven by PO | Drug | Treatment group |
| Active SurveillanceGiven by Observation | Other | Observation group |
Primary outcome
Safety and adverse events (AEs)
Time frame: 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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 May 2026.
- MD Anderson Cancer CenterLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Eric Jonasch, MD principal investigator
M.D. Anderson Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Belzutifan and Active Surveillance in people with Active Surveillance and Clear Cell Renal Cell Carcinoma, run by M.D. Anderson Cancer Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 28 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 22 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Eric Jonasch, MD (713-563-7232, ejonasch@mdanderson.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety and adverse events (AEs) (time frame: Through study completion; an average of 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 May 2026.