NCT07011719

Study of Casdatifan and Cabozantinib Versus Placebo and Cabozantinib in Patients With Advanced Clear Cell Renal Cell Carcinoma

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

• Status: Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 720 (estimated)
• Sponsor: Arcus Biosciences, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of the study is to evaluate the progression-free survival (PFS) of casdatifan versus placebo when each is given in combination with cabozantinib in adult patients with confirmed advanced or metastatic clear cell Renal Cell Carcinoma who have experienced progression on or after prior anti-PD-1 or anti-PD-L1 immunotherapy.

Conditions

• Metastatic Clear Cell Renal Cell Carcinoma
• Advanced Clear Cell Renal Cell Carcinoma

Interventions

Type	Name	Description
DRUG	Casdatifan	Administered as specified in the treatment arm
DRUG	Cabozantinib	Administered as specified in the treatment arm
DRUG	Placebo	Administered as specified in the treatment arm

Timeline

• Start date: 2025-09-08
• Primary completion: 2028-04-01
• Completion: 2030-12-01
• First posted: 2025-06-10
• Last updated: 2026-04-01

Locations

44 sites across 9 countries: United States, France, Germany, Netherlands, Poland, Romania, South Korea, Spain, United Kingdom

Regulatory

• FDA-regulated drug study