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A Randomized, Double-Blind, Placebo-Controlled Phase 2 Study Comparing CB-839 in Combination With Everolimus (CBE) vs. Placebo With Everolimus (PboE) in Patients With Advanced or Metastatic Renal Cell Carcinoma (RCC)

Primary Objectives To compare the progression free survival (PFS) of patients treated with CB-839 + everolimus (CBE) versus placebo + everolimus (PboE) for advanced or metastatic clear cell RCC (ccRCC) previously treated with:  At least 2 lines of therapy, including at least one vascular endothelial growth factor (VEGFR) tyrosine kinase inhibitor (TKI)  At least one of cabozantinib or nivolumab (or other active anti-PD-1/PD-L1 therapy). Secondary Objectives To compare the overall survival (OS) of study patients treated with CBE vs. PboE To compare the investigator-reported PFS of patients treated with CBE vs. PboE Additional Objectives To compare the objective response rate (ORR), Duration of Response (DOR), and Disease Control Rate (DCR) of CBE vs. PboE To compare the safety and tolerability of CBE vs. PboE To investigate the population pharmacokinetics (PK) of CB-839 To investigate the relationship of genetic variants and response to CBE vs. PboE Change in kidney-cancer related symptoms Change in mobility, self-care, usual activities, pain/discomfort, and anxiety/depression, and global health



Recruitment Status

Past Studies