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

NCT ID: NCT07227402

Last Updated: 2025-12-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE3

Total Enrollment

904 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-11-26

Study Completion Date

2032-02-27

Brief Summary

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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.

Detailed Description

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Conditions

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Renal Cell Carcinoma

Keywords

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Carcinoma Renal cell Belzutifan Zanzalintinib

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Belzutifan plus Zanzalintinib

Participants will receive belzutifan orally once daily (QD) PLUS zanzalintinib orally QD until one of the reasons for discontinuation of study intervention are met.

Group Type EXPERIMENTAL

Belzutifan

Intervention Type DRUG

Administered orally QD

Zanzalintinib

Intervention Type DRUG

Administered orally QD

Cabozantinib

Participants will receive cabozantinib orally QD until one of the reasons for discontinuation of study intervention are met.

Group Type ACTIVE_COMPARATOR

Cabozantinib

Intervention Type DRUG

Administered orally QD

Interventions

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Belzutifan

Administered orally QD

Intervention Type DRUG

Zanzalintinib

Administered orally QD

Intervention Type DRUG

Cabozantinib

Administered orally QD

Intervention Type DRUG

Other Intervention Names

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MK-6482 PT2977 WELIREG™ XL092

Eligibility Criteria

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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
* Has hepatitis B or hepatitis C virus
* Received a live or live-attenuated vaccine within 30 days before the first dose of study intervention
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Exelixis

INDUSTRY

Sponsor Role collaborator

Merck Sharp & Dohme LLC

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Medical Director

Role: STUDY_DIRECTOR

Merck Sharp & Dohme LLC

Locations

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Asociación de Beneficencia Hospital Sirio Libanés ( Site 0205)

Caba, Buenos Aires, Argentina

Site Status RECRUITING

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

Sydney, New South Wales, Australia

Site Status RECRUITING

Ordensklinikum Linz GmbH Elisabethinen-Urologie ( Site 0600)

Linz, Upper Austria, Austria

Site Status RECRUITING

UZ Gent ( Site 0702)

Ghent, Oost-Vlaanderen, Belgium

Site Status RECRUITING

Masarykuv onkologicky ustav ( Site 0903)

Brno, Brno-mesto, Czechia

Site Status RECRUITING

Nemocnice České Budějovice ( Site 0905)

České Budějovice, , Czechia

Site Status RECRUITING

Fakultni nemocnice v Motole ( Site 0900)

Prague, , Czechia

Site Status RECRUITING

Herlev Hospital ( Site 1002)

Herlev, Capital Region, Denmark

Site Status RECRUITING

Odense Universitetshospital ( Site 1000)

Odense, Region Syddanmark, Denmark

Site Status RECRUITING

Centre d'Oncologie de Gentilly ( Site 1117)

Nancy, Lorraine, France

Site Status RECRUITING

Helios Kliniken Schwerin GmbH ( Site 1206)

Schwerin, Mecklenburg-Vorpommern, Germany

Site Status RECRUITING

Universitaetsklinikum Carl Gustav Carus Dresden ( Site 1213)

Dresden, Saxony, Germany

Site Status RECRUITING

HELIOS Klinikum Erfurt ( Site 1208)

Erfurt, Thuringia, Germany

Site Status RECRUITING

Metropolitan Hospital ( Site 1302)

Athens, Attica, Greece

Site Status RECRUITING

Queen Mary Hospital ( Site 2201)

Hong Kong, , Hong Kong

Site Status RECRUITING

Istituto Nazionale Tumori Regina Elena ( Site 1611)

Rome, Lazio, Italy

Site Status RECRUITING

Fondazione Policlinico Universitario Agostino Gemelli IRCCS - Università Cattolica del Sacro Cuore ( Site 1601)

Rome, Roma, Italy

Site Status RECRUITING

Casa di Cura Dott. Pederzoli - UO Oncologia ( Site 1610)

Peschiera del Garda, Veneto, Italy

Site Status RECRUITING

Azienda USL 8 di Arezzo ( Site 1605)

Arezzo, , Italy

Site Status RECRUITING

Ospedale San Martino ( Site 1606)

Genova, , Italy

Site Status RECRUITING

Pratia MCM Krakow ( Site 1713)

Krakow, Lesser Poland Voivodeship, Poland

Site Status RECRUITING

Wojewodzki Szpital im. Sw. Ojca Pio w Przemyslu ( Site 1710)

Przemyśl, Podkarpackie Voivodeship, Poland

Site Status RECRUITING

Samsung Medical Center ( Site 2502)

Seoul, , South Korea

Site Status RECRUITING

Hospital Universitario Marqués de Valdecilla ( Site 1807)

Santander, Cantabria, Spain

Site Status RECRUITING

Institut Català d'Oncologia (ICO) - Girona ( Site 1806)

Girona, Gerona, Spain

Site Status RECRUITING

Hospital Universitario Ramón y Cajal ( Site 1801)

Madrid, Madrid, Comunidad de, Spain

Site Status RECRUITING

Fundación Instituto Valenciano de Oncología ( Site 1808)

Valencia, Valenciana, Comunitat, Spain

Site Status RECRUITING

Hospital Clinic de Barcelona ( Site 1810)

Barcelona, , Spain

Site Status RECRUITING

Hospital Universitario Reina Sofia ( Site 1809)

Córdoba, , Spain

Site Status RECRUITING

Hospital Clinico San Carlos ( Site 1802)

Madrid, , Spain

Site Status RECRUITING

Hospital Universitario Fundacion Jimenez Diaz ( Site 1803)

Madrid, , Spain

Site Status RECRUITING

Hospital Universitario 12 de Octubre ( Site 1800)

Madrid, , Spain

Site Status RECRUITING

China Medical University Hospital ( Site 2603)

Taichung, , Taiwan

Site Status RECRUITING

Taipei Veterans General Hospital ( Site 2600)

Taipei, , Taiwan

Site Status RECRUITING

Countries

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Argentina Australia Austria Belgium Czechia Denmark France Germany Greece Hong Kong Italy Poland South Korea Spain Taiwan

Central Contacts

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Toll Free Number

Role: CONTACT

Phone: 1-888-577-8839

Email: [email protected]

Facility Contacts

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Related Links

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https://www.merckclinicaltrials.com/

Merck Clinical Trials Information

Other Identifiers

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U1111-1311-6892

Identifier Type: REGISTRY

Identifier Source: secondary_id

2024-517136-21

Identifier Type: REGISTRY

Identifier Source: secondary_id

6482-033

Identifier Type: -

Identifier Source: org_study_id