Recruiting NCT07227402
A Clinical Study of Belzutifan and Zanzalintinib in People With Recurrent Kidney Cancer Following Adjuvant Therapy (MK-6482-033)
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Belzutifan, Zanzalintinib, Cabozantinib.
- Who it may be relevant to
- Registry conditions: Renal Cell Carcinoma. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States, Argentina, Australia, Austria, Belgium +18
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
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)
Overview
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.
Interventions
- Drug Belzutifan
Administered orally QD - Drug Zanzalintinib
Administered orally QD - Drug Cabozantinib
Administered orally QD
Primary outcome measures
- Progression Free Survival (PFS) [Time frame: Up to approximately 73 months]
- Overall Survival (OS) [Time frame: Up to approximately 73 months]
Secondary outcome measures (12)
- Objective Response Rate (ORR) [Time frame: Up to approximately 73 months]
- Duration of Response (DOR) [Time frame: Up to approximately 73 months]
- Number of Participants Who Experience One or More Adverse Events (AEs) [Time frame: Up to approximately 73 months]
- Number of Participants Who Discontinue Study Treatment due to an AE [Time frame: Up to approximately 73 months]
- Change From Baseline in European Organisation for the Research and Treatment of Cancer Quality of Life Questionnaire 30 (EORTC QLQ-C30) Global Health/Health-Related Quality of Life (HRQoL) Items 29 and 30 Combined Score [Time frame: Up to approximately 25 months]
- Change From Baseline in EORTC QLC-C30 Physical Functioning Items 1-5 Score [Time frame: Up to approximately 25 months]
- Change From Baseline in EORTC QLQ-C30 Role Functioning Items 6-7 Score [Time frame: Up to approximately 25 months]
- Change From Baseline in Functional Assessment of Cancer Therapy-Kidney Symptom Index-Disease-related Symptoms (FKSI-DRS) Items 1-9 Score [Time frame: Up to approximately 25 months]
- Time From Baseline to First Deterioration in EORTC-QLC-C30 Global Health/HRQoL Score [Time frame: Up to approximately 25 months]
- Time From Baseline to First Deterioration in EORTC-QLC-C30 Physical Functioning Score [Time frame: Up to approximately 25 months]
- Time From Baseline to First Deterioration in EORTC-QLC-C30 Role Functioning Score [Time frame: Up to approximately 25 months]
- Time From Baseline to First Deterioration in FKSI-DRS Score [Time frame: Up to approximately 25 months]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
Italy · 14 centers
- Azienda Ospedaliera Di Rilievo Nazionale A. Cardarelli ( Site 1609) — Naples
- Istituto Nazionale Tumori Regina Elena ( Site 1611) — Rome
- Fondazione IRCCS Istituto Nazionale dei Tumori ( Site 1600) — Milan
- Istituto Clinico Humanitas ( Site 1613) — Rozzano
- … and 10 more centers
France · 11 centers
- CHU de Bordeaux Hop St ANDRE ( Site 1115) — Bordeaux
- Hôpital Foch ( Site 1118) — Suresnes
- Centre de Cancérologie du Grand Montpellier ( Site 1112) — Montpellier
- CHU GRENOBLE ALPES ( Site 1101) — La Tronche
- Centre d'Oncologie de Gentilly ( Site 1117) — Nancy
- Centre Hospitalier Universitaire d'Angers-Urology ( Site 1104) — Angers
- Centre Hospitalier de la Cote Basque ( Site 1113) — Bayonne
- centre hospitalier lyon sud ( Site 1102) — Pierre-Bénite
- … and 3 more centers
Germany · 11 centers
- Klinikum Stuttgart - Katharinenhospital ( Site 1201) — Stuttgart
- UniversitaetsklInikum Tuebingen ( Site 1207) — Tübingen
- Universitätsmedizin Göttingen - Georg-August-Universität ( Site 1211) — Göttingen
- Helios Kliniken Schwerin GmbH ( Site 1206) — Schwerin
- Marienhospital Herne ( Site 1215) — Herne
- Universitaetsklinikum Muenster ( Site 1202) — Münster
- Universitaetsklinikum Carl Gustav Carus Dresden ( Site 1213) — Dresden
- HELIOS Klinikum Erfurt ( Site 1208) — Erfurt
- … and 3 more centers
Spain · 11 centers
Center list to be confirmed — check the primary protocol.
United States · 10 centers
- Alaska Oncology and Hematology ( Site 0133) — Anchorage
- Providence Medical Foundation ( Site 0141) — Fullerton
- USC Norris Comprehensive Cancer Center ( Site 0126) — Los Angeles
- Cedars-Sinai Medical Center ( Site 0112) — Los Angeles
- New England Cancer Specialists ( Site 0132) — Westbrook
- Greater Baltimore Medical Center ( Site 0145) — Baltimore
- Metro-Minnesota Community Clinical Oncology ( Site 0144) — Saint Louis Park
- Oncology Hematology West P.C. dba Nebraska Cancer Specialists ( Site 0131) — Omaha
- … and 2 more centers
Argentina · 9 centers
- Hospital Aleman ( Site 0204) — CABA
- Hospital Italiano de Buenos Aires. ( Site 0203) — Caba
- Asociación de Beneficencia Hospital Sirio Libanés ( Site 0205) — Caba
- Instituto Alexander Fleming ( Site 0202) — CABA
- Hospital Universitario Austral ( Site 0212) — Pilar
- Centro de Educación Médica e Investigaciones clínicas "Dr. Norberto Quirno" (CEMIC) ( Site — Caba.
- Sanatorio Parque ( Site 0201) — Rosario
- Instituto de Oncología de Rosario ( Site 0209) — Rosario
- … and 1 more center
Poland · 8 centers
Center list to be confirmed — check the primary protocol.
Czechia · 7 centers
- Masarykuv onkologicky ustav ( Site 0903) — Brno
- Fakultni nemocnice Ostrava ( Site 0904) — Ostrava
- Nemocnice České Budějovice ( Site 0905) — České Budějovice
- Fakultni nemocnice Hradec Kralove ( Site 0902) — Hradec Králové
- Fakultni nemocnice Olomouc ( Site 0901) — Olomouc
- Vseobecna fakultni nemocnice v Praze ( Site 0906) — Prague
- Fakultni nemocnice v Motole ( Site 0900) — Prague
South Korea · 6 centers
Center list to be confirmed — check the primary protocol.
Brazil · 5 centers
- IPC - MT Instituto de Pesquisas Clínicas do Mato Grosso ( Site 0305) — Cuiabá
- Liga Norte Riograndense Contra o Câncer ( Site 0307) — Natal
- Hospital Moinhos de Vento ( Site 0309) — Porto Alegre
- Fundação Faculdade Regional de Medicina de São José do Rio Preto ( Site 0302) — São José do Rio Preto
- Hospital Alemao Oswaldo Cruz ( Site 0311) — São Paulo
Mexico · 5 centers
Center list to be confirmed — check the primary protocol.
Belgium · 4 centers
- Cliniques Universitaires Saint-Luc ( Site 0703) — Brussels
- Ziekenhuis Oost-Limburg, Campus St.-Jan ( Site 0701) — Genk
- UZ Gent ( Site 0702) — Ghent
- UZ Leuven ( Site 0700) — Leuven
Taiwan · 4 centers
Center list to be confirmed — check the primary protocol.
Chile · 3 centers
- Oncocentro Valdivia ( Site 0408) — Valdivia
- Fundacion Arturo Lopez Perez ( Site 0401) — Santiago
- Centro de Investigacion Clinica UC CICUC ( Site 0402) — Santiago
Croatia · 3 centers
- Klinički bolnički centar Sestre milosrdnice ( Site 0801) — Zagreb
- Klinički bolnički centar Zagreb ( Site 0800) — Zagreb
- Klinički Bolnički Centar Split ( Site 0802) — Split
Denmark · 3 centers
- Herlev Hospital ( Site 1002) — Herlev
- Aarhus University Hospital Skejby ( Site 1001) — Aarhus
- Odense Universitetshospital ( Site 1000) — Odense
Greece · 3 centers
- Alexandra General Hospital of Athens ( Site 1300) — Athens
- Metropolitan Hospital ( Site 1302) — Athens
- University General Hospital ''Attikon'' - General Hospital of West Attica "H AGIA VARVARA" — Chaïdári
Austria · 2 centers
- Ordensklinikum Linz GmbH Elisabethinen-Urologie ( Site 0600) — Linz
- Medizinische Universitat Wien ( Site 0601) — Vienna
Hong Kong · 2 centers
- Prince of Wales Hospital ( Site 2200) — Hong Kong
- Queen Mary Hospital ( Site 2201) — Hong Kong
Ireland · 2 centers
- Cork University Hospital ( Site 1501) — Cork
- Tallaght University Hospital ( Site 1500) — Dublin
Singapore · 2 centers
Center list to be confirmed — check the primary protocol.
Australia · 1 center
- Macquarie University-MQ Health Clinical Trials Unit ( Site 2100) — Sydney
United Kingdom · 1 center
Center list to be confirmed — check the primary protocol.
Identifiers
NCT: NCT07227402 · 6482-033 · U1111-1311-6892 · 2024-517136-21