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, 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.
Keywords: CTLA-4; PD-1; balstilimab; cervical cancer; immuno-oncology; zalifrelimab.
Source: PubMed