Trial purpose
Cancer treatment
Tumor type
Genitourinary
Age
18+
Clinical summary
Summary
Participants enrolled in this trial will be randomised into one of two arms. In the experimental arm, CB-839 will be given orally twice daily and cabozantinib once daily. In the comparator arm a placebo will be given orally twice daily and cabozantinib once daily.
Conditions
This trial is treating people with renal cell carcinoma
Eligibility
Inclusion
- Documented histological or cytological diagnosis of renal cell carcinoma with a clear-cell component
- Adult patients
- Karnofsky Performance Score (KPS) ≥ 70%
- Measurable Disease per Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1)
- 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
- Adequate hepatic, renal, cardiac and hematologic function
Exclusion
- Prior treatment with cabozantinib (or other mesenchymal-epithelial transition [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 human immunodeficiency virus (HIV), Hepatitis B or C virus
- Inability to discontinue proton-pump-inhibitor use before randomization
- Patients who are pregnant or lactating
Inclusion
- Your cancer has spread to other parts of the body (metastatic) or has grown into nearby parts of the body (locally advanced).
- You are able to swallow medication by mouth.
- You have had a certain type of treatment or surgical procedure.
Exclusion
- You have certain types of non-cancer medical conditions.
- You have had certain treatments, surgical procedures or drugs.
Clinical trials have complex eligibility criteria, and other criteria may apply for this trial. Ask your doctor about whether this trial could be right for you.
More information
Trial Identifiers
Information on this page is partially produced from ClinicalTrials.gov *. View further details about this trial on the registry via the links below:
Trial sponsor
Calithera Biosciences, Inc
Scientific 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 (RCC)
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