RaPiDS (GOG-3028): randomized Phase II study of balstilimab alone or in combination with zalifrelimab in cervical cancer.
california; irvine; sjh
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.
Women & Children
Obstetrics & Gynecology
O'Malley, David M; Randall, Leslie M; Jackson, Camille Gunderson; Coleman, Robert L; Hays, John L; Moore, Kathleen N; Naumann, R Wendel; Rocconi, Rodney P; Slomovitz, Brian M; Tewari, Krishnansu S; Ancukiewicz, Marek; Feliu, Waldo Ortuzar; and Monk, Bradley J, "RaPiDS (GOG-3028): randomized Phase II study of balstilimab alone or in combination with zalifrelimab in cervical cancer." (2021). Articles, Abstracts, and Reports. 5219.