RaPiDS (GOG-3028): Randomized Phase II Study of Balstilimab Alone or in Combination with Zalifrelimab in Cervical Cancer
David M. O’Malley, Leslie M. Randall, Camille Gunderson Jackson, Robert L. Coleman, John L. Hays, Kathleen N. Moore, R. Wendel Naumann, Rodney P. Rocconi, Brian M. Slomovitz, Krishnansu S. Tewari, Marek Ancukiewicz, Waldo Ortuzar Feliu, Bradley J. Monk
Abstract
Balstilimab (anti-programmed death 1) and zalifrelimab (anti-CTLA-4) are two new checkpoint inhibitors that have emerged as promising investigational agents for the treatment of cervical cancer, particularly in the setting of previously-treated, recurrent/metastatic disease. Here we describe the rationale and design of RaPiDS (NCT03894215), a two-arm Phase II study evaluating the safety, tolerability and efficacy of balstilimab administered alone or in combination with zalifrelimab in patients with advanced cervical cancer who progressed after first-line, platinum-based chemotherapy. Patients will be randomized in a 1:1 ratio. The primary end point is objective response rate, and key secondary objectives include safety, duration of response, progression-free survival, overall survival and quality of life outcomes.