Randomized Phase 3 Trial of Casdatifan & Cabozantinib Vs Placebo & Cabozantinib
Research type
Research Study
Full title
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.
IRAS ID
1012660
Contact name
Thomas Powles
Contact email
Sponsor organisation
Syneos Health UK Ltd
Clinicaltrials.gov Identifier
Research summary
The study is designed as a Phase 3, randomized, active-control, placebo-controlled, double-blind, 2-arm, global, multicenter study in adult patients with confirmed advanced or metastatic ccRCC who have experienced progression on or after prior anti-PD-1 or anti-PD-L1 based immunotherapy.
Primary objective of the study is to compare OS of casdatifan + cabozantinib versus placebo + cabozantinib in all randomized patients.
Approximately 720 patients will be enrolled and randomized 2:1 to Arm A or Arm B (detailed below). Patient randomization will be stratified by region (North America vs Western Europe vs rest of world)
The study is made up of three parts: Screening, Treatment, and Follow Up. The length of the study is anticipated to be approximately 5 years.
There are 2 arms in the study:
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 once a day (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.REC name
London - Fulham Research Ethics Committee
REC reference
25/LO/0605
Date of REC Opinion
14 Oct 2025
REC opinion
Further Information Favourable Opinion