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New treatment option for Renal Cell Carcinoma
Official title A Clinical Study of Belzutifan and Zanzalintinib in People With Recurrent Kidney Cancer Following Adjuvant Therapy (MK-6482-033)
ClinicalTrials.gov ID: NCT07227402
What this study is testing
What is Belzutifan?
Belzutifan is an investigational medicine, given as a pill taken by mouth, being studied as a potential treatment for renal cell carcinoma.
Also referred to as MK-6482, PT2977.
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
- Researchers are looking for more ways to treat advanced renal cell carcinoma (RCC) that is recurrent. Researchers want to learn if recurrent advanced renal cell carcinoma (RCC) responds (gets smaller or goes away) after treatment with belzutifan (MK-6482) and zanzalintinib compared to cabozantinib.
- Phase 3: a large, late-stage study
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
- The main include but are not limited to the following:
- Has a histologically confirmed diagnosis of unresectable, advanced renal cell cancer (RCC) with clear cell component (with or without sarcomatoid...
- Has measurable disease per Response Evaluation Criteria in Solid Tumors 1.1 (RECIST 1.1)
- Has disease recurrence during adjuvant anti-programmed cell death 1/programmed cell death ligand 1 (PD-1/L1) therapy or recurrence ≤24 months...
- Has received no other prior systemic therapy for their RCC except for their adjuvant anti-PD-1/L1 therapy
You likely can't join if
- The main exclusion criteria include but are not limited to the following:
- Has clinically significant cardiovascular disease within 12 months from first dose of study intervention, including New York Heart Association Class...
- Had deep vein thrombosis within 3 months before randomization unless stable, asymptomatic, and treated with therapeutic anticoagulation for at least...
- Has a left ventricular ejection fraction ≤50% or below the institutional (or local laboratory) normal range as determined by multigated acquisition...
- Has had major surgery within 8 weeks before randomization or has not adequately recovered from major surgery or has ongoing surgical complications
- Has current pneumonitis/interstitial lung disease
See the full eligibility criteria
- The main include but are not limited to the following:
- Has a histologically confirmed diagnosis of unresectable, advanced renal cell cancer (RCC) with clear cell component (with or without sarcomatoid features) i.e., Stage IV renal cell cancer per American Joint Committee...
- Has measurable disease per Response Evaluation Criteria in Solid Tumors 1.1 (RECIST 1.1)
- Has disease recurrence during adjuvant anti-programmed cell death 1/programmed cell death ligand 1 (PD-1/L1) therapy or recurrence ≤24 months following the last dose of adjuvant anti-PD-1/L1 therapy
- Has received no other prior systemic therapy for their RCC except for their adjuvant anti-PD-1/L1 therapy
- The main exclusion criteria include but are not limited to the following:
- Has clinically significant cardiovascular disease within 12 months from first dose of study intervention, including New York Heart Association Class III or IV congestive heart failure, unstable angina, new-onset angina...
- Had deep vein thrombosis within 3 months before randomization unless stable, asymptomatic, and treated with therapeutic anticoagulation for at least 4 weeks before randomization
- Has a left ventricular ejection fraction ≤50% or below the institutional (or local laboratory) normal range as determined by multigated acquisition or echocardiogram
- Has had major surgery within 8 weeks before randomization or has not adequately recovered from major surgery or has ongoing surgical complications
- Has current pneumonitis/interstitial lung disease
- Has symptomatic pleural effusion (for example cough, dyspnea, pleuritic chest pain), ascites, or pericardial fluid requiring drainage within 4 weeks prior to randomization
- Has a gastrointestinal disorder including those associated with a high risk of perforation or fistula formation
- Has a serious active nonhealing wound/ulcer/bone fracture
- Has a requirement for hemodialysis or peritoneal dialysis
- Has history of human immunodeficiency virus infection
- Has hepatitis B or hepatitis C virus
- Has pharmacologically uncompensated, symptomatic hypothyroidism
- Received a live or live-attenuated vaccine within 30 days before the first dose of study intervention
The study team makes the final eligibility decision.
Where it's taking place
- Anchorage, Alaska, United States
- Fullerton, California, United States
- Westbrook, Maine, United States
- Baltimore, Maryland, United States
- Saint Louis Park, Minnesota, United States
- Omaha, Nebraska, United States
- Charlotte, North Carolina, United States
- CABA, Buenos Aires, Argentina
- Pilar, Buenos Aires, Argentina
- Caba., Buenos Aires F.D., Argentina
- Rosario, Santa Fe Province, Argentina
- Córdoba, Argentina
- Sydney, New South Wales, Australia
- Linz, Upper Austria, Austria
- Vienna, Austria
- Brussels, Bruxelles-Capitale, Region de, Belgium
- Genk, Limburg, Belgium
- Ghent, Oost-Vlaanderen, Belgium
- Leuven, Vlaams-Brabant, Belgium
- Cuiabá, Mato Grosso, Brazil
+ 83 more site(s).
Compensation & support
A stipend or compensation may be offered.
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
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 Anchorage, Alaska, United States; Fullerton, California, United States; Westbrook, Maine, United States; Baltimore, Maryland, United States; Saint Louis Park, Minnesota, United States; Omaha, Nebraska, United States and 97 more location(s). Enter your location above to see the nearest site and check your eligibility.
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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.