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Clinical Trials in the UK / NCT07489495
Recruiting Phase 3

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

NCT07489495 · tracked via the Priya Life Science UK tracker
Sponsor
Merck Sharp & Dohme LLC
Phase
Phase 3
Started
2026-04-09
Last updated
2026-09-11

Condition(s) studied

Carcinoma, Renal Cell

Investigational drug(s) / intervention(s)

BelzutifanZanzalintinibPlacebo

Belzutifan: Tablet for oral administration.

Zanzalintinib: Tablet for oral administration.

Placebo: Zanzalintinib-matching placebo tablet for oral administration.

Study summary

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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
Healthy volunteers
No
Inclusion Criteria: 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 Criteria: 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

Primary outcome measure(s)

Trial sites (89)

FacilityCityRegionStatus
Northwest Georgia Oncology Centers, a Service of Wellstar Cobb Hospital ( Site 0102) Marietta Georgia Recruiting
Washington University School of Medicine ( Site 0114) St Louis Missouri Recruiting
Memorial Sloan Kettering Cancer Center ( Site 0126) New York New York Recruiting
The West Clinic, P.C. ( Site 0115) Germantown Tennessee Recruiting
Centro Oncologico Korben ( Site 0254) CABA Buenos Aires Recruiting
Hospital Italiano de Buenos Aires ( Site 0253) Ciudad de Buenos Aires Buenos Aires Recruiting
Instituto de Investigaciones Clinicas Mar del Plata ( Site 0250) Mar del Plata Buenos Aires Recruiting
Centro Privado de RMI Río Cuarto S.A. II ( Site 0255) Río Cuarto Córdoba Province Recruiting
Sanatorio Parque ( Site 0251) Rosario Santa Fe Province Recruiting
Instituto de Oncología de Rosario ( Site 0257) Rosario Santa Fe Province Recruiting
Instituto Alexander Fleming ( Site 0252) CABA Argentina Recruiting
Centro Oncológico Riojano Integral ( Site 0256) La Rioja Argentina Recruiting
COE (Centro Oncológico de Excelencia) ( Site 0259) San Juan Argentina Recruiting
Macquarie University ( Site 2700) Macquarie University New South Wales Suspended
Princess Alexandra Hospital ( Site 2703) Woolloongabba Queensland Suspended
Peter MacCallum Cancer Centre ( Site 2702) Melbourne Victoria Suspended
CEDOES ( Site 0303) Vitória Espírito Santo Recruiting
Instituto do Câncer e Transplante de Curitiba ( Site 0300) Curitiba Paraná Recruiting
Liga Norte Riograndense Contra o Câncer ( Site 0307) Natal Rio Grande do Norte Recruiting
Hope - Humanizacao Em Oncologia, Pesquisa E Ensino ( Site 0306) Ribeirão Preto São Paulo Recruiting
Fundação Faculdade Regional de Medicina de São José do Rio Preto ( Site 0302) São José do Rio Preto São Paulo Recruiting
IC La Serena Research ( Site 0405) La Serena Coquimbo Region Recruiting
Clínica Puerto Montt ( Site 0404) Port Montt Los Lagos Region Recruiting
Fundacion Arturo Lopez Perez ( Site 0401) Santiago Region M. de Santiago Recruiting
Bradfordhill ( Site 0400) Santiago Region M. de Santiago Recruiting
ONCOCENTRO APYS ( Site 0403) Viña del Mar Valparaiso Recruiting
Masarykuv onkologicky ustav ( Site 0903) Brno Brno-mesto Recruiting
Fakultni nemocnice Ostrava ( Site 0904) Ostrava Ostrava Mesto Recruiting
Fakultni nemocnice Hradec Kralove ( Site 0902) Hradec Králové Czechia Recruiting
Fakultni nemocnice Olomouc ( Site 0901) Olomouc Czechia Recruiting
Fakulti poliklinika ( Site 0906) Prague Czechia Recruiting
Fakultni nemocnice v Motole ( Site 0900) Prague Czechia Recruiting
Herlev Hospital ( Site 1002) Herlev Capital Region Recruiting
Aarhus Universitetshospital, Skejby ( Site 1001) Aarhus Central Jutland Recruiting
Centre Antoine Lacassagne ( Site 1209) Nice Alpes-Maritimes Recruiting
Hopital Europeen Marseille ( Site 1216) Marseille Bouches-du-Rhone Recruiting
LBM ONCOPOLE CLAUDIUS REGAUD ( Site 1215) Toulouse Haute-Garonne Recruiting
CHU Angers ( Site 1204) Angers Maine-et-Loire Recruiting
Clinique Victor Hugo Le Mans-Oncology-Radiotherapy ( Site 1203) Le Mans Pays de la Loire Region Recruiting
CHU de Saint-Etienne ( Site 1202) Saint Priest En Jarez Pays de la Loire Region Recruiting

+ 49 more sites — see the full list on the official registry below.

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07489495 on ClinicalTrials.gov ↗ ← All trials in the UK