CANTATA: CB-839 With Cabozantinib vs. Cabozantinib With Placebo in Patients With Metastatic Renal Cell Carcinoma
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
- Advanced Renal Cell Carcinoma
- Metastatic Renal Cell Carcinoma
Eligibility
- Eligible Ages
- Over 18 Years
- Eligible Genders
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- 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
- 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
Arm | Description | Assigned 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. |
|
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. |
|
More Details
- Status
- Completed
- Sponsor
- Calithera Biosciences, Inc