Study on Belzutifan and Zanzalintinib for Recurrent Kidney Cancer After Previous Treatment
Sponsor: Merck Sharp & Dohme LLC
ClinicalTrials ID:NCT07227402
This clinical trial is exploring whether a combination of the drugs belzutifan and zanzalintinib can help people with advanced kidney cancer live longer and prevent the cancer from worsening, compared to the drug cabozantinib.
Patient Parameters
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Program Overview
Researchers are investigating new treatment options for advanced kidney cancer that has returned after initial therapy. This study aims to find out if the combination of belzutifan and zanzalintinib can shrink or eliminate tumors more effectively than cabozantinib. The main goal is to see if patients taking belzutifan and zanzalintinib live longer and have a longer period without their cancer getting worse compared to those taking cabozantinib.
Eligibility Criteria
Inclusion Criteria
- Diagnosed with advanced kidney cancer that cannot be surgically removed, specifically Stage IV renal cell cancer with clear cell features.
- Have measurable tumors based on standard criteria.
- Experienced cancer recurrence during or within 24 months after completing adjuvant therapy with anti-PD-1/L1 drugs.
- Have not received any other systemic treatment for kidney cancer except for the adjuvant anti-PD-1/L1 therapy.
Exclusion Criteria
- Have significant heart problems within the past year, such as severe heart failure, unstable chest pain, heart attack, or irregular heartbeat causing instability.
- Had a blood clot in a deep vein within the last 3 months unless stable and treated for at least 4 weeks.
- Have a heart pumping ability of 50% or lower.
- Had major surgery within the last 8 weeks or have not fully recovered from surgery.
- Have current lung inflammation or disease.
- Have fluid buildup around the lungs, heart, or abdomen that needed drainage within the last 4 weeks.
- Have a gastrointestinal disorder with a high risk of complications.
- Have a serious non-healing wound, ulcer, or bone fracture.
- Require dialysis for kidney function.
- Have a history of HIV infection.
- Have hepatitis B or C.
- Have untreated or symptomatic low thyroid function.
- Received a live vaccine within 30 days before starting the study treatment.
Locations
| FACILITY | ZIP | CITY | STATE |
|---|---|---|---|
| Alaska Oncology and Hematology ( Site 0133) | 99508 | Anchorage | Alaska |
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