CANTATA: CB-839 With Cabozantinib vs. Cabozantinib With Placebo in Patients With Metastatic Renal… (NCT03428217) | Clinical Trial Compass
CompletedPhase 2
CANTATA: CB-839 With Cabozantinib vs. Cabozantinib With Placebo in Patients With Metastatic Renal Cell Carcinoma
United States444 participantsStarted 2018-04-24
Plain-language summary
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).
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. 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 criteria
✕. 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
✕
What they're measuring
1
Progression-Free Survival (PFS) as Assessed by the Independent Radiology Committee (IRC)
Timeframe: Up to the primary analysis data cut-off date of 31 Aug 2020. Maximum duration of follow-up for PFS was 22.14 months.