Clinical Trials | PEAK-1: A Randomized, Double-Blind, Active-Control, Multicenter Phase 3 Trial of Casdatifan and Cabozantinib Versus Placebo and Cabozantinib in Patients with Advanced Clear Cell Renal Cell Carcinoma

The University of Virginia Comprehensive Cancer Center seeks participants ages 18 and over with a kidney cancer for a research study. The purpose of this study is to evaluate the potential benefits of investigational casdatifan in combination with cabozantinib versus placebo and cabozantinib in patients with advanced or metastatic ccRCC who have experienced progression on or after prior anti-programmed cell death protein 1 (PD-1)/anti-programmed death-ligand 1 (PD-L1) therapy. All the participants will be randomized 2:1 to Arm A or Arm B: Arm A (Experimental Arm) Doses and administration of casdatifan and cabozantinib will be administered using a 28-day cycle: • Casdatifan administered orally at 100 mg QD of each cycle. • Cabozantinib administered orally at 60 mg QD of each cycle. Arm B (Comparator Arm) Doses and administration of placebo and cabozantinib will be administered using a 28-day cycle: • Placebo administered orally QD of each cycle. • Cabozantinib administered orally at 60 mg QD of each cycle. The study is made up of three parts: Screening, Treatment, and Follow Up. The study duration for each participant is expected to be approximately 21 months but could be longer or shorter depending on how your disease progresses.