Testing two new drugs against cabozantinib for returning kidney cancer
Tests belzutifan with zanzalintinib in adults with kidney cancer that has returned.
Plain-language title generated from the registry record
Registry title: A Clinical Study of Belzutifan and Zanzalintinib in People With Recurrent Kidney Cancer Following Adjuvant Therapy (MK-6482-033)
Key facts
- Where
- Genk, Gent, Leuven, and Sint-Lambrechts-Woluwe, BelgiumSee the 4 sites
- Phase
- Phase 3
Where in Belgium
- Ziekenhuis Oost-LimburgGenk, BelgiumTaking people
- Universitair Ziekenhuis GentGent, BelgiumTaking people
- UZ LeuvenLeuven, BelgiumTaking people
- Cliniques Universitaires Saint-LucSint-Lambrechts-Woluwe, BelgiumTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Merck Sharp & Dohme LLC
- Trial code
- NCT07227402EU 2024-517136-21-00
- Record updated
- 3 August 2026
- Original description
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.Read full original descriptionShow less
A Phase 3, Randomized, Open-label Study of Belzutifan + Zanzalintinib Versus Cabozantinib in Participants With Advanced RCC Who Experienced Disease Recurrence During or After Prior Adjuvant Anti-PD-1/L1 Therapy (LITESPARK-033)
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.
The goal of this study is to learn if:
People who take belzutifan and zanzalintinib live longer overall and without the cancer getting worse than people who take cabozantinib.
Inclusion: The main inclusion criteria 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 on Cancer (AJCC) (8th Edition); 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.
Exclusion: 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 had major surgery within 8 weeks before randomization or has not adequately recovered from major surgery or has ongoing surgical complications; Has symptomatic pleural effusion (for example cough, dyspnea, pleuritic chest pain), ascites, or pericardial fluid requiring drainage within 4 weeks prior to randomization; Received a live or live-attenuated vaccine within 30 days before the first dose of study intervention; 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, pulmonary embolism, myocardial infarction, cerebral vascular accident, or cardiac arrhythmia associated with hemodynamic instability; Has current pneumonitis/interstitial lung disease; 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 history of human immunodeficiency virus infection; Has hepatitis B or hepatitis C virus; Has a left ventricular ejection fraction ≤50% or below the institutional (or local laboratory) normal range as determined by multigated acquisition or echocardiogram; The main exclusion criteria include but are not limited to the following:; Has a requirement for hemodialysis or peritoneal dialysis; Has pharmacologically uncompensated, symptomatic hypothyroidism.