CONTACT-03 is a global, multicenter, randomized, phase 3, open-label study that aims to enroll approximately 500 patients. Patients will be randomized 1:1 to the experimental arm of cabozantinib in combination with atezolizumab or the control arm of cabozantinib alone. The co-primary endpoints of the trial are progression-free survival per Response Evaluation Criteria in Solid Tumors (RECIST) v. 1.1 as assessed by independent review and overall survival. Secondary endpoints include progression-free survival, objective response rate and duration of response as assessed by the investigators. The CONTACT-03 trial is sponsored by Roche and co-funded by Exelixis.
“The treatment landscape for metastatic kidney cancer is rapidly evolving as the use of immune checkpoint inhibitor-based regimens move to earlier lines of therapy,” said Gisela Schwab, M.D., President, Product Development and Medical Affairs and Chief Medical Officer, Exelixis. “More data are needed to better understand the sequential use of treatments for this patient community, and we look forward to learning more about the potential role of the combination of cabozantinib and atezolizumab following checkpoint inhibitor therapy in this pivotal trial with our partner Roche.”
In the U.S., CABOMETYX (cabozantinib) tablets are approved for the treatment of patients with advanced RCC and for the treatment of patients with HCC who have been previously treated with sorafenib. CABOMETYX tablets have also received regulatory approvals in the European Union and additional countries and regions worldwide.
CABOMETYX in combination with atezolizumab is not indicated for metastatic renal cell carcinoma, yet.