Belzutifan with zanzalintinib or placebo in advanced kidney cancer after earlier treatments
Tests adding zanzalintinib to belzutifan in adults with advanced renal cell carcinoma.
Plain-language title generated from the registry record
Registry title: A Clinical Study of Belzutifan (MK-6482) and Zanzalintinib in People With Renal Cell Carcinoma (RCC) (LITESPARK-034/LS-034/MK-6482-034)
Key facts
- Where
- Angers, Dijon, Le Mans, Marseille, Nice Cedex 2, Paris, Saint-Priest-en-Jarez, Toulouse Cedex 9, and Villejuif, FranceSee the 9 sites
- Phase
- Phase 3
Where in France
- Centre Hospitalier Universitaire D'AngersAngers, FranceTaking people
- Centr Georges Francois LeclercDijon, FranceTaking people
- Clinique Victor HugoLe Mans, FranceTaking people
- Hopital Europeen MarseilleMarseille, FranceTaking people
- Centre Antoine LacassagneNice Cedex 2, FranceTaking people
- Assistance Publique Hopitaux de ParisParis, FranceTaking people
- Centre Hospitalier Universitaire de Saint EtienneSaint-Priest-en-Jarez, FranceTaking people
- Centre Hospitalier Universitaire De ToulouseToulouse Cedex 9, FranceTaking people
- Institut Gustave RoussyVillejuif, FranceTaking 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
- NCT07489495EU 2024-516993-31-00
- Record updated
- 10 November 2026
- Original description
Researchers are looking for new ways to treat advanced renal cell carcinoma (RCC).Read full original descriptionShow less
A Phase 3, Randomized, Double-blind, Study of Belzutifan + Zanzalintinib Versus Belzutifan + Placebo in Participants With Advanced RCC Who Have Progressed on or After Both PD-1/L1 and VEGF-TKI Therapies in Sequence or in Combination (LITESPARK-034)
Researchers are looking for new ways to treat advanced renal cell carcinoma (RCC).
A standard (usual) treatment for certain people with RCC is belzutifan (a study medicine), which is a targeted therapy. Targeted therapy is a treatment that works to control how specific types of cancer cells grow and spread. Researchers want to learn if adding another targeted therapy called zanzalintinib (another study medicine) can treat more people with advanced RCC than belzutifan alone.
The goal of this study is to learn if people who receive belzutifan and zanzalintinib live longer overall and without the cancer getting worse compared to people who receive belzutifan and placebo.
Inclusion: The main inclusion criteria include but are not limited to the following:; Has a histologically confirmed diagnosis of unresectable, advanced renal cell carcinoma (RCC) with clear cell component (with or without sarcomatoid features) ie, Stage IV RCC per American Joint Committee on Cancer (8th Edition); Has measurable disease per Response Evaluation Criteria In Solid Tumors Version 1.1 (RECIST 1.1); Has received no more than 3 prior systemic regimens for RCC, including only 1 prior anti-Programmed Cell Death-1/Programmed Cell Death 1 Ligand 1 therapy.
Exclusion: Has 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; Has not adequately recovered from major surgery or has ongoing surgical complications; Has clinically significant cardiovascular disease within 12 months from first dose of study intervention; Has current pneumonitis/interstitial lung disease; Has a history of human immunodeficiency virus infection; Has Hepatitis B or Hepatitis C virus infection; Has a known additional malignancy that is progressing or has required active treatment within the past 3 years; Has a history of solid organ transplant; Has a left ventricular ejection fraction ≤50% or below the institutional (or local laboratory) normal range as determined by multigated acquisition or echocardiogram; For exclusion criteria: The main exclusion criteria include but are not limited to the following:; Has any of the following: a pulse oximeter reading <92% at rest, requires intermittent supplemental oxygen, or required chronic supplemental oxygen.