To test this hypothesis, Dr. Elena Verzoni from Milan, Italy presented the trial design of the BREAKPOINT trial, a phase II, open-label trial evaluating the efficacy of cabozantinib in patients with advanced or unresectable RCC who were previously treated with a prior PD-1 or PDL-1 inhibitor and showed disease progression. Eligible patients must have a confirmed histopathologic diagnosis of predominately clear cell RCC and must have had one prior anticancer treatment with a PD-1 or PDL-1 inhibitor. Exclusion criteria include prior medical treatment for metastatic RCC, a surgical procedure within 28 days, or symptomatic brain metastases. Patients will receive 60mg of cabozantinib daily until they show evidence of clinical disease progression. The primary outcome of the study is progression-free survival, with secondary outcomes of overall survival, objective response rate, and drug safety and tolerability.
Verzoni’s study began enrolling patients in June 2018 and hopes to enroll 49 patients, with a minimum of follow-up of 10 months. She believes that this study will help to better inform treatment decisions for patients with unresectable or locally advanced renal cell carcinoma who show disease progression after initial treatment with PD-1 or PDL-1 inhibitors. She looks forward to presenting the data in the future once the trial completes accrual and the adequate follow-up period has been reached.
Presented by: lena Verzoni, MD