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
- Bydgoszcz, Cracow, Koszalin, Przemyśl, Siedlce, Skorzewo, and Warsaw, PolandSee the 8 sites
- Phase
- Phase 3
AI summary: who the study is looking for
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for adults whose advanced kidney cancer (clear cell type) came back during or after earlier treatment given after surgery with an anti-PD-1/L1 medicine.
- Age
- 18 years or older
- Sex
- All sexes can join
- Disease stage
- Advanced kidney cancer (renal cell cancer) that cannot be removed by surgery, Stage IV, with a clear cell part, with or without sarcomatoid features. The disease must be measurable (RECIST 1.1).
- Earlier treatment
- The cancer came back during adjuvant anti-PD-1/L1 therapy, or 24 months or less after the last dose. No other earlier drug treatment for the kidney cancer is allowed.
Main reasons for not taking part
- Serious heart or blood vessel disease within 12 months before the first dose
- Need for hemodialysis or peritoneal dialysis
- History of HIV infection, or hepatitis B or C
- Current pneumonitis or interstitial lung disease
- Major surgery within 8 weeks before randomization
Read by machine on 12 November 2026.
Where in Poland
- Centrum Onkologii Im. Prof. Franciszka Lukaszczyka W BydgoszczyBydgoszcz, PolandTaking people
- Pratia S.A.Cracow, PolandTaking people
- Szpital Specjalistyczny Im. Ludwika Rydygiera W Krakowie Sp. z o.o.Cracow, PolandTaking people
- Szpital Wojewodzki im. Mikolaja Kopernika w KoszalinieKoszalin, PolandTaking people
- Wojewodzki Szpital im Sw Ojca Pio w PrzemysluPrzemyśl, PolandTaking people
- Mazowiecki Szpital Wojewodzki Im. Sw. Jana Pawła II W Siedlcach Sp. z o.o.Siedlce, PolandTaking people
- Aidport sp z o.o.Skorzewo, PolandTaking people
- Pratia S.A.Warsaw, PolandTaking 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?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorTrial details
- Who runs it
- Merck Sharp & Dohme LLC
- Trial code
- NCT07227402EU 2024-517136-21-00
- Record updated
- 12 November 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.