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

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, ≤ 72 hours 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 prior malignancy active within the previous year except for locally curable cancers that have been apparently cured. - Clinically significant toxicities related to any prior anticancer treatment, or toxicities Grade ≥ 3 per National Cancer Institute Common Terminology Criteria for Adverse Events, version 5.0 (NCI CTCAE v5.0) regardless of relatedness to prior anticancer therapies. - Uncontrolled or poorly controlled hypertension, as defined by a sustained blood pressure > 140/90 mm Hg on more than three antihypertensives - History of leptomeningeal disease or spinal cord compression. NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.