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

Detailed criteria

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…

Interventions

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

Locations (44)

City of Hope - Phoenix Cancer Center
Goodyear, Arizona
Mayo Clinic - Phoenix
Phoenix, Arizona
City Of Hope National Medical Center
Duarte, California
University of California San Diego Moores Cancer Center
La Jolla, California
UCLA Hematology Oncology - 100 Med Plaza
Los Angeles, California
University of California San Diego Moores Cancer Center
San Diego, California