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

Inclusion Criteria:

   1. Documented histological or cytological diagnosis of renal cell carcinoma with a
   clear-cell component

   2. Adult patients

   3. Karnofsky Performance Score (KPS) ≥ 70%

   4. Measurable Disease per Response Evaluation Criteria in Solid Tumors version 1.1
   (RECIST v1.1)

   5. 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

   6. Adequate hepatic, renal, cardiac and hematologic function

Exclusion Criteria:

   1. Prior treatment with cabozantinib (or other mesenchymal-epithelial transition [MET]
   inhibitor) or CB-839

   2. Receipt of other anticancer therapy within 2-6 weeks, depending on the treatment

   3. Untreated or active brain metastases or central nervous system cancer, as defined per
   protocol

   4. Prior gastric surgery, small bowel resection, or other conditions that may impede
   adequate absorption of oral study drug

   5. Known active infection with human immunodeficiency virus (HIV), Hepatitis B or C virus

   6. Inability to discontinue proton-pump-inhibitor use before randomization

   7. Patients who are pregnant or lactating