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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

  • Rohit Jain

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

Study Title

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



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
  • One and not more than two prior systemic lines of therapy (monotherapy or combination regimen) for advanced or metastatic RCC
  • Must include either:
  • one anti-angiogenic therapy (any VEGF pathway-targeted agent, used either as monotherapy or as a component of a combination regimen)
  • OR
  • the combination regimen of nivolumab + ipilimumab
  • Exposure to a prior treatment regimen for ≥4 weeks is considered a prior line of therapy, regardless of reason for its discontinuation (exception: high-dose IL2 will count as prior therapy if >3 doses administered)
  • 4 weeks will be counted from first to last dose for regimens that are intended to be administered on daily schedules (e.g., sunitinib, pazopanib) and from first dose to end of cycle length after last dose for regimens that are intended to be administered in intervals of ≥ 1 week (e.g., one treatment of a Q2W regimen counts as 2 weeks of therapy)
  • Rechallenge with the same agent or regimen will not be considered a new line of therapy, if the Participant had not previously discontinued that agent or regimen because of disease progression
  • Systemic adjuvant therapy is considered a prior line of therapy if the Participant has disease recurrence on or within 1 year after the last dose of adjuvant therapy
  • The Participant must have had radiographic evidence of disease progression on or after the most recent systemic therapy and within 6 mo before randomization

  • 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