CANTATA: CB-839 With Cabozantinib vs. Cabozantinib With Placebo in Patients With Metastatic Renal Cell Carcinoma

Inclusion Criteria

• Documented histological or cytological diagnosis of renal cell carcinoma with a clear-cell component
• Adult patients
• Karnofsky Performance Score (KPS) ≥ 70%
• Measurable Disease per Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1)
• 1-2 lines of prior therapy for advanced or metastatic renal cell carcinoma (RCC) including one anti-angiogenic therapy (any vascular endothelial growth factor [VEGF] pathway-targeted agent used either as monotherapy or as a component of a combination regimen) OR the combination regimen of nivolumab + ipilimumab
• Adequate hepatic, renal, cardiac and hematologic function

Exclusion Criteria

• Prior treatment with cabozantinib (or other mesenchymal-epithelial transition [MET] inhibitor) or CB-839
• Receipt of other anticancer therapy within 2-6 weeks, depending on the treatment
• Untreated or active brain metastases or central nervous system cancer, as defined per protocol
• Prior gastric surgery, small bowel resection, or other conditions that may impede adequate absorption of oral study drug
• Known active infection with human immunodeficiency virus (HIV), Hepatitis B or C virus
• Inability to discontinue proton-pump-inhibitor use before randomization
• Patients who are pregnant or lactating