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)
Fase: Phase II-III clinical trials
Principal Investigator: Dott. Procopio Giuseppe
Struttura Principale: Oncologia Medica Genitourinaria
Farmaco: Belzutifan (120 mg qd) + Zanzalintinb (60 mg qd) versus Cabozantinb (60 mg qd)
Patologie: Tumori urologici (rene, vescica, vie urinarie, altri)
Each participant will participate in the study for approximately 5 years from the time the participant provides documented informed consent through the final protocol-specified contact. After a screening period of up to 28 days, each participant will be receiving assigned study intervention for approximately 24 months. After the end of treatment each participant will be followed for approximately 3 years. After screening, each participant will be assigned to receive study intervention until one of the conditions for discontinuation of study intervention is met. Participants who discontinue for reasons other than radiographic disease progression will have posttreatment follow-up imaging for disease status until any of the conditions for discontinuation of imaging are met. After the end of treatment, each participant will be followed for the occurrence of AEs, SAEs, and other reportable safety events. In addition, all participants will be followed for overall survival until death, withdrawal of consent, the end of the study, or enrollment into an extension study (if applicable).
Last update: 17/04/2026