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Clinical Trial 19671

Cancer Type: Genitourinary
Interventions:CB-839/Placebo; Cabozantinib (XL 184); Not Applicable

Study Type: Treatment
Phase of Study: Phase II
Investigators:

  • Rohit Jain

Call 813-745-6100
or 1-800-679-0775
Overview

Study Title

A Randomized, Double-Blind, Placebo-Controlled Phase 2 Study Comparing CB-839 in Combination with Cabozantinib (CB-Cabo) vs. Placebo with Cabozantinib (Pbo-Cabo) in Patients with Advanced or Metastatic Renal Cell Carcinoma Metastatic Renal Cell Carcinoma (RCC)

Summary

Objective

Primary objectives: To compare blinded Independent Radiology Committee (IRC)-adjudicated progression free survival (PFS) of patients treated with CB-839 + cabozantinib (CB-Cabo) versus placebo + cabozantinib (Pbo-Cabo) for advanced or metastatic clear-cell RCC(ccRCC) Secondary objectives: - To compare the overall survival (OS) of patients treated with CB-Cabo vs. Pbo-Cabo - To compare the investigator-assessed PFS of patients treated with CB-Cabo vs. Pbo-Cabo. Additional Objectives: To compare the overall response rate (ORR), Duration of Response (DOR), and Disease Control Rate (DCR) of CB-Cabo vs. Pbo- Cabo - To compare the safety and tolerability of CB-Cabo vs. Pbo-Cabo - To investigate the population pharmacokinetics (PK) of CB-839 using sparse PK sampling - To investigate the relationship of genetic variants and response to CB-Cabo vs. Pbo- Cabo - To compare quality of life (QoL) changes from baseline of patients treated with CBCabo vs. Pbo-Cabo

Inclusion Criteria

  • Documented histological or cytological diagnosis of renal cell carcinoma with a clear-cell component
  • Over 18 years of age
  • Karnofsky Performance Score (KPS) ≥ 70%
  • Measurable Disease per RECIST 1.1
  • 1-2 lines of prior therapy for advanced or metastatic RCC including at least one antiangiogenic therapy or nivolumab + ipilimumab
  • Adequate hepatic, renal, cardiac and hematologic function

  • Exclusion Criteria

  • Prior treatment with cabozantinib (or other 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 HIV, Hepatitis B or C virus
  • Requirement for continued proton pump inhibitor after randomization