Phase 2
Completed N=444
CANTATA: CB-839 With Cabozantinib vs. Cabozantinib With Placebo in Patients With Metastatic Renal Cell Carcinoma
Source: ClinicalTrials.gov NCT03428217 ↗Enrolled (actual)
444
Serious AEs
37.1%
Results posted
Mar 2023
Primary outcomePrimary: Progression-Free Survival (PFS) as Assessed by the Independent Radiology Committee (IRC) — 9.33; 9.17 months — p=0.6528
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).
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Progression-Free Survival (PFS) as Assessed by the Independent Radiology Committee (IRC) |
9.33; 9.17 | 0.6528 |
| SECONDARY Overall Survival (OS) |
24.84; 22.24 | 0.3867 |
| SECONDARY PFS as Assessed by the Investigator |
8.38; 9.17 | 0.9692 |
Eligibility Criteria
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
- Inability to discontinue proton-pump-inhibitor use before randomization
- Patients who are pregnant or lactating
Data sourced from ClinicalTrials.gov (NCT03428217). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.