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)

Condition studied

Renal Cell Carcinoma

Investigational medicinal product(s)

Eligibility

Primary endpoint

Progression free survival, Overall survival

Endpoint detail

Objective Response Rate, Duration of Response, Number of participants with ≥1 AE(s), Number of participants who discontinue study therapy due to AE(s), 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) score, Change from baseline in EORTC QLC-C30 physical functioning score, Change from baseline in EORTC QLQ-C30 role functioning score, Change from baseline in Functional Assessment of Cancer Therapy-Kidney Symptom Index-Disease-related Symptoms (FKSI-DRS) score, Time from baseline to first deterioration in EORTC-QLC-C30 global health/HRQoL score, Time from baseline to first deterioration in EORTC-QLC-C30 physical functioning score, Time from baseline to first deterioration in EORTC-QLC-C30 role functioning score, Time from baseline to first deterioration in FKSI-DRS score