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Clinical Trials in Ireland / NCT07227402
Recruiting Phase 3

A Clinical Study of Belzutifan and Zanzalintinib in People With Recurrent Kidney Cancer Following Adjuvant Therapy (MK-6482-033)

NCT07227402 · tracked via the Priya Life Science Ireland tracker
Sponsor
Merck Sharp & Dohme LLC
Phase
Phase 3
Started
2025-11-26
Last updated
2026-08-03

Condition(s) studied

Renal Cell Carcinoma

Investigational drug(s) / intervention(s)

BelzutifanZanzalintinibCabozantinib

Belzutifan: Administered orally QD

Zanzalintinib: Administered orally QD

Cabozantinib: Administered orally QD

Study summary

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.

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 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 Criteria: The main exclusion criteria include but are not limited to the following: * 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 * 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 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 or has not adequately recovered from major surgery or has ongoing surgical complications * Has current pneumonitis/interstitial lung disease * Has symptomatic pleural effusion (for example cough, dyspnea, pleuritic chest pain), ascites, or pericardial fluid requiring drainage within 4 weeks prior to randomization * 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 a requirement for hemodialysis or peritoneal dialysis * Has history of human immunodeficiency virus infection * Has hepatitis B or hepatitis C virus * Has pharmacologically uncompensated, symptomatic hypothyroidism * Received a live or live-attenuated vaccine within 30 days before the first dose of study intervention

Primary outcome measure(s)

Trial sites (127)

FacilityCityRegionStatus
Alaska Oncology and Hematology ( Site 0133) Anchorage Alaska Recruiting
Providence Medical Foundation ( Site 0141) Fullerton California Recruiting
USC Norris Comprehensive Cancer Center ( Site 0126) Los Angeles California Recruiting
Cedars-Sinai Medical Center ( Site 0112) Los Angeles California Recruiting
New England Cancer Specialists ( Site 0132) Westbrook Maine Recruiting
Greater Baltimore Medical Center ( Site 0145) Baltimore Maryland Recruiting
Metro-Minnesota Community Clinical Oncology ( Site 0144) Saint Louis Park Minnesota Recruiting
Oncology Hematology West P.C. dba Nebraska Cancer Specialists ( Site 0131) Omaha Nebraska Recruiting
Carolina Oncology Specialists, PA ( Site 9002) Charlotte North Carolina Recruiting
Thompson Cancer Survival Center ( Site 0125) Knoxville Tennessee Recruiting
Hospital Aleman ( Site 0204) CABA Buenos Aires Recruiting
Hospital Italiano de Buenos Aires. ( Site 0203) Caba Buenos Aires Recruiting
Asociación de Beneficencia Hospital Sirio Libanés ( Site 0205) Caba Buenos Aires Recruiting
Instituto Alexander Fleming ( Site 0202) CABA Buenos Aires Recruiting
Hospital Universitario Austral ( Site 0212) Pilar Buenos Aires Recruiting
Centro de Educación Médica e Investigaciones clínicas "Dr. Norberto Quirno" (CEMIC) ( Site 0208) Caba. Buenos Aires F.D. Recruiting
Sanatorio Parque ( Site 0201) Rosario Santa Fe Province Recruiting
Instituto de Oncología de Rosario ( Site 0209) Rosario Santa Fe Province Recruiting
Hospital Privado Universitario de Córdoba ( Site 0207) Córdoba Argentina Recruiting
Macquarie University-MQ Health Clinical Trials Unit ( Site 2100) Sydney New South Wales Recruiting
Ordensklinikum Linz GmbH Elisabethinen-Urologie ( Site 0600) Linz Upper Austria Recruiting
Medizinische Universitat Wien ( Site 0601) Vienna Austria Recruiting
Cliniques Universitaires Saint-Luc ( Site 0703) Brussels Bruxelles-Capitale, Region de Recruiting
Ziekenhuis Oost-Limburg, Campus St.-Jan ( Site 0701) Genk Limburg Recruiting
UZ Gent ( Site 0702) Ghent Oost-Vlaanderen Recruiting
UZ Leuven ( Site 0700) Leuven Vlaams-Brabant Recruiting
IPC - MT Instituto de Pesquisas Clínicas do Mato Grosso ( Site 0305) Cuiabá Mato Grosso Recruiting
Liga Norte Riograndense Contra o Câncer ( Site 0307) Natal Rio Grande do Norte Recruiting
Hospital Moinhos de Vento ( Site 0309) Porto Alegre Rio Grande do Sul Recruiting
Fundação Faculdade Regional de Medicina de São José do Rio Preto ( Site 0302) São José do Rio Preto São Paulo Recruiting
Hospital Alemao Oswaldo Cruz ( Site 0311) São Paulo São Paulo Recruiting
Oncocentro Valdivia ( Site 0408) Valdivia Los Ríos Region Recruiting
Fundacion Arturo Lopez Perez ( Site 0401) Santiago Region M. de Santiago Recruiting
Centro de Investigacion Clinica UC CICUC ( Site 0402) Santiago Region M. de Santiago Recruiting
Klinički bolnički centar Sestre milosrdnice ( Site 0801) Zagreb City of Zagreb Recruiting
Klinički bolnički centar Zagreb ( Site 0800) Zagreb City of Zagreb Recruiting
Klinički Bolnički Centar Split ( Site 0802) Split Split-Dalmatia County Recruiting
Masarykuv onkologicky ustav ( Site 0903) Brno Brno-mesto Recruiting
Fakultni nemocnice Ostrava ( Site 0904) Ostrava Ostrava Mesto Recruiting
Nemocnice České Budějovice ( Site 0905) České Budějovice Czechia Recruiting

+ 87 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 NCT07227402 on ClinicalTrials.gov ↗ ← All trials in Ireland