Purpose

Tthe primary objective of this study is 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).

Conditions

Eligibility

Eligible Ages
Over 18 Years
Eligible Genders
All
Accepts Healthy Volunteers
No

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

Study Design

Phase
Phase 2
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Intervention Model Description
This is a double blinded placebo-controlled study where patients will be randomized 1:1 to either CB-839 (telaglenastat) plus cabozantinib or placebo plus cabozantinib
Primary Purpose
Treatment
Masking
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description
Participants, care providers, investigators and outcomes assessors are blinded to treatment. Progression free survival (PFS) will be assessed by a blinded Independent Radiology Committee for the primary endpoint of the study.

Arm Groups

ArmDescriptionAssigned Intervention
Placebo Comparator
Pbo-Cabo
Placebo twice daily (BID) + cabozantinib (60 mg once daily [QD]) administered orally on Days 1 through 28 of each 28-day cycle until disease progression per Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1) or unacceptable toxicity, whichever occurred first.
  • Drug: Cabozantinib
    Oral receptor tyrosine kinase inhibitor
    Other names:
    • Cabometyx
    • Cabometriq
  • Drug: Placebo
    Placebo tablets
Experimental
CB-Cabo
CB-839 800 mg BID + cabozantinib (60 mg QD) administered orally on Days 1 through 28 of each 28-day cycle until disease progression per RECIST v1.1 or unacceptable toxicity, whichever occurred first.
  • Drug: CB-839
    Oral glutaminase inhibitor
    Other names:
    • telaglenastat
  • Drug: Cabozantinib
    Oral receptor tyrosine kinase inhibitor
    Other names:
    • Cabometyx
    • Cabometriq

More Details

Status
Completed
Sponsor
Calithera Biosciences, Inc

Study Contact

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.