CANTATA is an international, multi-center, randomized, double-blind, phase 2 study evaluating CB-839 + cabozantinib versus placebo + cabozantinib in patients with mRCC. Key eligibility criteria include 1-2 prior lines of systemic therapy including >= 1 anti-angiogenic therapy or the combination of nivolumab + ipilimumab, KPS ≥70%, measurable disease by RECIST 1.1, and adequate hepatic, renal, cardiac and hematologic function. Key exclusion criteria include no prior treatment with MET inhibitors, including cabozantinib, receipt of recent anticancer therapy, prior gastrointestinal surgery that may impede drug absorption, HIV, and hepatitis B/C. The study start date is 2018 and it is projected to come to completion in 2022 after enrollment of 300 patients.
The patients are randomized 1:1 and treatment is continued in 28-day cycles until disease progression or unacceptable toxicity. Patients are stratified by prior PD-1/PD-L-1 immunotherapy and by their prognostic risk group. The primary outcome measure is progression-free survival (PFS) by independent radiology review using RECIST 1.1 criteria, and secondary outcome measures are PFS by the investigator and overall survival (OS). Safety and quality of life measures are also assessed.
This trial will provide information about the safety and efficacy of CB-839, a first in-clinic (oral) metabolic inhibitor in combination with cabozantinib, an anti-angiogenic agent in patients with mRCC and progression after 1-2 prior systemic treatments.
Presented by: Nizar Tannir, MD, FACP, Department of Genitourinary Medical Oncology, Division of Cancer Medicine, MD Anderson Cancer Center, Texas
Written by: Selma Masic, MD, Urologic Oncology Fellow (SUO), Fox Chase Cancer Center, @selmasic at the 2019 American Society of Clinical Oncology Genitourinary Cancers Symposium, (ASCO GU) #GU19, February 14-16, 2019 - San Francisco, CA