CANTATA: CB-839 With Cabozantinib vs. Cabozantinib With Placebo in Patients With Metastatic Renal Cell Carcinoma

Trial ID or NCT#

NCT03428217

Status

not recruiting iconNOT RECRUITING

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).

Official 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)

Eligibility Criteria

Ages Eligible for Study: Older than 18 Years
Sexes Eligible for Study: All
Accepts Healthy Volunteers: No
Inclusion Criteria:
  1. 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. 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
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Investigator(s)

Alice C. Fan
Alice C. Fan
Medical oncologist, Genitourinary specialist
Assistant Professor of Medicine (Oncology) and, by courtesy, of Urology

Contact us to find out if this trial is right for you.

Contact

Shemeen Poushnejad
650-724-7662

View on ClinicalTrials.gov