Clinical trial 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?
This is an investigational oral medicine being studied as a potential treatment for advanced renal cell carcinoma. It is designed to block a protein called HIF-2α, which helps control how cells grow and make blood vessels.
Also referred to as MK-6482, PT2977, WELIREG.
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
- This study aims to find out if taking belzutifan and zanzalintinib helps people live longer and keeps the cancer from getting worse compared to taking cabozantinib.
- Who it's for
- The study is looking for people with advanced kidney cancer that has come back after previous treatment.
- What's involved
- Participants will take either the new combination of drugs or the standard drug, and doctors will monitor how the cancer responds over time.
- Time commitment
- The study involves regular check-ups to track health and cancer status, but the specific total duration is not listed in the provided text.
- 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
- 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
- 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
- Has symptomatic pleural effusion (for example cough, dyspnea, pleuritic chest pain), ascites, or pericardial fluid requiring drainage within 4 weeks...
See the full eligibility criteria
- 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
- 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 is enrolling
- Anchorage, Alaska, United States
- Fullerton, California, United States
- Los Angeles, 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
- Knoxville, Tennessee, United States
- Nashville, Tennessee, 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
+ 91 more site(s).
Compensation & support
A stipend or payment for your time may be offered.
No amount is published here because ClinicalTrials.gov has no reliable field for payment or travel support. Ask the study team what's actually covered (payment for your time, travel, parking, or other study costs), and never join a trial for the compensation alone.
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, so 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, but 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?
This study is enrolling now at Anchorage, Alaska, United States; Fullerton, California, United States; Los Angeles, California, United States; Westbrook, Maine, United States; Baltimore, Maryland, United States; Saint Louis Park, Minnesota, United States and 105 more locations. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.