A Randomized, Double-Blind, Active-Control, Multicenter Phase III Trial of Casdatifan and Cabozantinib Versus Placebo and Cabozantinib in Patients With Advanced Clear Cell Renal Cell Carcinoma
Categories (click each to see list of all clinical trials associated with that category): GU (ONC)
Current Status: Not open
Phase: III (Cancer Control) (Cancer Prevention)
Principal Investigator: Leuva, Harshraj
Contact Information:
Heather Mittelstedt
hmittelstedt@unmc.edu
Eligibility: https://clinicaltrials.gov/study/NCT07011719?term=NCT07011719&rank=1#participation-criteria
Summary
Primary Objective:
To compare PFS of casdatifan + cabozantinib versus placebo + cabozantinib in all randomized patients.
Secondary Objectives: - To compare OS of casdatifan + cabozantinib versus placebo + cabozantinib in all randomized patients. - To assess additional measures of clinical activity in all randomized patients. - To assess the safety and tolerability of casdatifan or placebo in combination with cabozantinib in all patients treated. - To evaluate disease-related symptoms based on patient-reported outcomes using NFKSI-19 of casdatifan + cabozantinib versus placebo + cabozantinib in all randomized patients.
Exploratory Objectives: - To describe the PK profile of casdatifan. - To evaluate the relationship between the tumor characteristics and blood-based biomarkers with clinical responses following combination treatment. - To assess measures of clinical activity in all randomized patients as assessed by the investigators. - To evaluate disease-related symptoms and quality of life based on patient-reported outcomes of casdatifan + cabozantinib versus placebo + cabozantinib in all randomized patients. - To compare PFS-2 for casdatifan + cabozantinib versus placebo + cabozantinib in all randomized patients.