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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
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