Study 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.