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)

ReclutandoFase 3ClinicalTrials.gov

ID: NCT07227402Tipo: INTERVENTIONALInicio: 26 de nov de 2025Fin estimado: 27 de feb de 2032

Traducción no disponible, mostrando original

Resumen

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.

Elegibilidad

Edad mínima: 18 YearsSexo: ALL

Criterios de inclusión

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

Criterios de exclusión

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

Intervenciones

drug

Belzutifan

Administered orally QD

drug

Zanzalintinib

Administered orally QD

drug

Cabozantinib

Administered orally QD

Ubicaciones

Asociación de Beneficencia Hospital Sirio Libanés ( Site 0205)

Caba, Buenos Aires, Argentina

Study Coordinator · +541145740870

RECRUITING

Instituto Alexander Fleming ( Site 0202)

CABA, Buenos Aires, Argentina

Study Coordinator · +541132218900

RECRUITING

Sanatorio Parque ( Site 0201)

Rosario, Santa Fe Province, Argentina

Study Coordinator · +5493416955611

RECRUITING

Instituto de Oncología de Rosario ( Site 0209)

Rosario, Santa Fe Province, Argentina

Study Coordinator · +5493414218909

RECRUITING

Hospital Privado Universitario de Córdoba ( Site 0207)

Córdoba, Argentina

Study Coordinator · +543514688200

RECRUITING

Patrocinadores

PrincipalMerck Sharp & Dohme LLC

ColaboradorExelixis

Contactos

Toll Free Number

CONTACT

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

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