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

Completed · Phase 2 · Has a placebo group

Conditions studied: Advanced Renal Cell Carcinoma, Metastatic Renal Cell Carcinoma

In brief

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).

Key facts

Study ID

NCT03428217

Run by

Calithera Biosciences, Inc

People needed

444

Starts

2018-04-24

Expected to finish

2021-07-16

Last updated by the study team

2023-03-20

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Mayo Clinic Cancer Center — Phoenix, Arizona, United States
• The University of Arizona Cancer Center — Tucson, Arizona, United States
• Cedars-Sinai Medical Center, Samuel Oschin Comprehensive Cancer Institute — Los Angeles, California, United States
• Stanford Cancer Center — Palo Alto, California, United States
• Salinas Valley Memorial Healthcare System — Salinas, California, United States
• St. Joseph Heritage Healthcare — Santa Rosa, California, United States
• Penrose Cancer Center, Research Department — Colorado Springs, Colorado, United States
• Georgetown University Medical Center — Washington D.C., District of Columbia, United States
• Florida Cancer Specialists — Fort Myers, Florida, United States
• University of Miami Sylvester Comprehensive Cancer Center — Miami, Florida, United States
• Florida Cancer Specialists — St. Petersburg, Florida, United States
• H.Lee Moffitt Cancer & Research Institute (Moffitt Cancer Center) — Tampa, Florida, United States
• Emory Winship Cancer Institute — Atlanta, Georgia, United States
• Georgia Cancer Center at Augusta University — Augusta, Georgia, United States
• Northwest Georgia Oncology Centers, PC — Marietta, Georgia, United States
• St. Luke's Mountain States Tumor Institute — Boise, Idaho, United States
• Northwestern University — Chicago, Illinois, United States
• University of Chicago — Chicago, Illinois, United States
• NorthShore University HealthSystem — Evanston, Illinois, United States
• AMITA Health Cancer Institute & Outpatient Center — Hinsdale, Illinois, United States
• Orchard Healthcare Research, Inc. — Skokie, Illinois, United States
• Northwestern Medicine Cancer Center Warrenville — Warrenville, Illinois, United States
• Goshen Center for Cancer Care — Goshen, Indiana, United States
• East Jefferson General Hospital — Metairie, Louisiana, United States
• University of Alabama at Birmingham — Birmingham, Alabama, United States

Full record on ClinicalTrials.gov

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