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Compares treatment options for Active Surveillance
Official title Belzutifan's Role in Active Surveillance Versus Treatment for Indolentmetastatic Clear Cell Renal Ccell Carcinoma (BRAVE-RCC)
ClinicalTrials.gov ID: NCT07023432
What this study is testing
What is Belzutifan?
Belzutifan is an investigational medicine, being studied as a potential treatment for active surveillance.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- 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...
- Metastatic disease that is documented by imaging with CT or MRI and measurable by RECIST1.1.
You likely can't join if
- 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...
- Impairment of gastrointestinal function or disease that may significantly alter the absorption of belzutifan (e.g., uncontrolled nausea, vomiting...
- Prior cardiovascular event including myocardial infarction, rest claudication, stroke, unstable angina, central nervous system (CNS) hemorrhage...
- Received colony-stimulating factors (eg, granulocyte colony stimulating factor, granulocytemacrophage colony stimulating factor or recombinant...
See the full eligibility criteria
Who can 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...
- 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: i. 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...
- 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...
- 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...
- 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 how well it works assessment of the investigational regimen are eligible...
What rules you out
- 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...
- 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...
- 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.
- 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...
- 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...
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Houston, Texas, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Houston, Texas, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.