RaPiDS (GOG-3028): randomized Phase II study of balstilimab alone or in combination with zalifrelimab in cervical cancer.

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.

• Authors: 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
• Journal: Future oncology (London, England) (Future Oncol) Vol. 17 Issue 26 Pg. 3433-3443 (Sep 2021) ISSN: 1744-8301 [Electronic] England
• PMID: 34409858 (Publication Type: Clinical Trial Protocol, Journal Article)

Chemical References

• Immune Checkpoint Inhibitors

Topics

• Adolescent
• Adult
• Aged
• Aged, 80 and over
• Antineoplastic Combined Chemotherapy Protocols (therapeutic use)
• Clinical Trials, Phase II as Topic (methods)
• Female
• Follow-Up Studies
• Humans
• Immune Checkpoint Inhibitors (therapeutic use)
• Middle Aged
• Prognosis
• Randomized Controlled Trials as Topic (methods)
• Uterine Cervical Neoplasms (drug therapy, immunology, pathology)
• Young Adult