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

RECRUITINGPHASE3

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

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)

NCT07227402•Merck Sharp & Dohme LLC

View on ClinicalTrials.gov

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

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•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

•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
+2 more criteria

Locations (87)

Asociación de Beneficencia Hospital Sirio Libanés ( Site 0205)

Caba, Buenos Aires, Argentina

Instituto Alexander Fleming ( Site 0202)

CABA, Buenos Aires, Argentina

Sanatorio Parque ( Site 0201)

Rosario, Santa Fe Province, Argentina

Instituto de Oncología de Rosario ( Site 0209)

Rosario, Santa Fe Province, Argentina

Hospital Privado Universitario de Córdoba ( Site 0207)

Córdoba, Argentina

Macquarie University-MQ Health Clinical Trials Unit ( Site 2100)

Sydney, New South Wales, Australia

Ordensklinikum Linz GmbH Elisabethinen-Urologie ( Site 0600)

Linz, Upper Austria, Austria

Medizinische Universitat Wien ( Site 0601)

Vienna, Austria

Cliniques Universitaires Saint-Luc ( Site 0703)

Brussels, Bruxelles-Capitale, Region de, Belgium

Ziekenhuis Oost-Limburg, Campus St.-Jan ( Site 0701)

Genk, Limburg, Belgium

Key Dates

Start Date

November 26, 2025

Primary Completion Date

February 27, 2032

Completion Date

February 27, 2032

Last Updated

March 16, 2026

Enrollment

904

ESTIMATED participants

Conditions

Renal Cell Carcinoma

Interventions

Belzutifan

DRUG

Zanzalintinib

DRUG

Cabozantinib

DRUG

Contacts

Toll Free Number

CONTACT

1-888-577-8839 Trialsites@msd.com

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: March 16, 2026Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

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

Inclusion Criteria

Exclusion Criteria

Association Between Galectin-3 Levels and Outcomes in Patients With Renal Cell Carcinoma, Transitional Cell Carcinoma , Non Small Cell Lung Cancer, and Hepatocellular Carcinoma, Treated With PD-1/PDL-1 Inhibitors

Ketogenic Dietary Intervention to Improve Response to Immunotherapy in Patients With Metastatic Melanoma and Metastatic Kidney Cancer

Neoadjuvant of Axitinib Plus PD-1 to Improve Disease Free Survival of Patients With Renal Cell Carcinoma

Immune Checkpoint Inhibitor Response in Solid Tumors Using a Live Tumor Diagnostic Platform

Open-Label Phase 1/2 Study of NEO-811 in Subjects With Locally Advanced or Metastatic Non-Resectable Clear Cell Renal Cell Carcinoma

Palbociclib and Sasanlimab for the Treatment of Advanced Clear Cell Renal Cell Carcinoma (ccRCC) or Papillary Renal Cell Carcinoma (pRCC)