A Clinical Study of Belzutifan (MK-6482) and Zanzalintinib in People With Renal Cell Carcinoma (RCC) (LITESPARK-034/LS-034/MK-6482-034)

Recruiting now · Phase 3 · Has a placebo group

Conditions studied: Carcinoma, Renal Cell

In brief

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.

Key facts

Study ID

NCT07489495

Run by

Merck Sharp & Dohme LLC

People needed

758

Starts

2026-04-09

Expected to finish

2030-11-27

Last updated by the study team

2026-07-27

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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
• Has clinically significant cardiovascular disease within 12 months from first dose of study intervention
• 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 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
• 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 not adequately recovered from major surgery or has ongoing surgical complications

Where it is running

• The West Clinic, P.C. ( Site 0115) — Germantown, Tennessee, United States (enrolling)
• Northwest Georgia Oncology Centers, a Service of Wellstar Cobb Hospital ( Site 0102) — Marietta, Georgia, United States (enrolling)
• Hospital Italiano de Buenos Aires ( Site 0253) — Ciudad de Buenos Aires, Buenos Aires, Argentina (enrolling)
• Instituto de Investigaciones Clinicas Mar del Plata ( Site 0250) — Mar del Plata, Buenos Aires, Argentina (enrolling)
• Centro Oncologico Korben ( Site 0254) — CABA, Buenos Aires, Argentina (enrolling)
• Sanatorio Parque ( Site 0251) — Rosario, Santa Fe Province, Argentina (enrolling)
• Instituto de Oncología de Rosario ( Site 0257) — Rosario, Santa Fe Province, Argentina (enrolling)
• Instituto Alexander Fleming ( Site 0252) — CABA, Argentina (enrolling)
• Centro Oncológico Riojano Integral ( Site 0256) — La Rioja, Argentina (enrolling)
• COE (Centro Oncológico de Excelencia) ( Site 0259) — San Juan, Argentina (enrolling)
• Centro Privado de RMI Río Cuarto S.A. II ( Site 0255) — Río Cuarto, Córdoba Province, Argentina (enrolling)
• CEDOES ( Site 0303) — Vitória, Espírito Santo, Brazil (enrolling)
• Instituto do Câncer e Transplante de Curitiba ( Site 0300) — Curitiba, Paraná, Brazil (enrolling)
• Liga Norte Riograndense Contra o Câncer ( Site 0307) — Natal, Rio Grande do Norte, Brazil (enrolling)
• Fundação Faculdade Regional de Medicina de São José do Rio Preto ( Site 0302) — São José do Rio Preto, São Paulo, Brazil (enrolling)
• Masarykuv onkologicky ustav ( Site 0903) — Brno, Brno-mesto, Czechia (enrolling)
• Fakultni nemocnice Ostrava ( Site 0904) — Ostrava, Ostrava Mesto, Czechia (enrolling)
• Fakultni nemocnice Hradec Kralove ( Site 0902) — Hradec Králové, Czechia (enrolling)
• Fakultni nemocnice v Motole ( Site 0900) — Prague, Czechia (enrolling)
• Herlev Hospital ( Site 1002) — Herlev, Capital Region, Denmark (enrolling)
• Aarhus Universitetshospital, Skejby ( Site 1001) — Aarhus, Central Jutland, Denmark (enrolling)
• Centre Antoine Lacassagne ( Site 1209) — Nice, Alpes-Maritimes, France (enrolling)
• Hopital Europeen Marseille ( Site 1216) — Marseille, Bouches-du-Rhone, France (enrolling)
• LBM ONCOPOLE CLAUDIUS REGAUD ( Site 1215) — Toulouse, Haute-Garonne, France (enrolling)
• CHU Angers ( Site 1204) — Angers, Maine-et-Loire, France (enrolling)

Full record on ClinicalTrials.gov

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