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

Research output: Contribution to journalArticlepeer-review

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.

Original languageEnglish (US)
Pages (from-to)3433-3443
Number of pages11
JournalFuture Oncology
Volume17
Issue number26
DOIs
StatePublished - Sep 2021
Externally publishedYes

Keywords

  • balstilimab
  • cervical cancer
  • CTLA-4
  • immuno-oncology
  • PD-1
  • zalifrelimab

ASJC Scopus subject areas

  • Oncology
  • Cancer Research

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