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
Arcus Biosciences, Inc.
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
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: * 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, ≤ 1 week prior to randomization. * Women of childbearing potential (WOCBP) must have a negative serum pregnancy test. Exclusion Criteria: * Received prior treatment with a HIF-2α inhibitor or cabozantinib. * Other prio…