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
Location: See all (10) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 3
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.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:
• Unresectable and measurable locally advanced or metastatic renal cell carcinoma with a primary clear cell component.
• A Karnofsky Performance Status (KPS) score ≥ 80%
• At least 1 target lesion measurable by computed tomography/magnetic resonance imaging per RECIST 1.1, not within a field of prior radiation therapy.
• Adequate organ and marrow function, ≤ 72 hours prior to randomization.
• Women of childbearing potential (WOCBP) must have a negative serum pregnancy test.
Locations
United States
Arizona
City of Hope - Phoenix Cancer Center
RECRUITING
Goodyear
California
City Of Hope National Medical Center
RECRUITING
Duarte
University of California San Diego Moores Cancer Center
RECRUITING
La Jolla
University of California San Diego Moores Cancer Center