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RaPiDS (GOG-3028): randomized Phase II study of balstilimab alone or in combination with zalifrelimab in cervical
David M O'Malley1, Leslie M Randall2, Camille Gunderson Jackson3
1Division of Gynecologic Oncology, The Ohio State University/James Comprehensive Cancer Center, Columbus, OH 43210, USA.
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.
Insights
Balstilimab (anti-PD-1) and zalifrelimab (anti-CTLA-4) show promise for advanced cervical cancer. The RaPiDS study evaluates their safety and efficacy in patients progressing after chemotherapy.
Area of Science:
- Oncology
- Immunotherapy
- Clinical Trials
Background:
- Advanced cervical cancer, particularly recurrent or metastatic disease post-chemotherapy, has limited treatment options.
- Checkpoint inhibitors, such as anti-programmed death 1 (PD-1) and anti-cytotoxic T-lymphocyte-associated protein 4 (CTLA-4) agents, are emerging as novel therapeutic strategies.
- Balstilimab (anti-PD-1) and zalifrelimab (anti-CTLA-4) represent new investigational agents in this class.
Purpose of the Study:
- To evaluate the safety, tolerability, and efficacy of balstilimab alone or in combination with zalifrelimab.
- To assess these agents in patients with advanced cervical cancer who have progressed on first-line platinum-based chemotherapy.
- To determine the objective response rate (ORR) as the primary endpoint.
Main Methods:
- The RaPiDS study (NCT03894215) is a two-arm, Phase II clinical trial.
- Patients with advanced cervical cancer progressing after first-line chemotherapy are randomized 1:1 to receive either balstilimab alone or balstilimab plus zalifrelimab.
- Key secondary objectives include safety, duration of response, progression-free survival, overall survival, and quality of life.
Main Results:
- This section describes the study design and rationale, not preliminary or final results.
- The primary endpoint is the objective response rate (ORR).
- Secondary endpoints provide a comprehensive assessment of treatment outcomes and patient well-being.
Conclusions:
- Balstilimab and zalifrelimab are being investigated as potential new treatments for advanced cervical cancer.
- The RaPiDS study will provide crucial data on the safety and efficacy of these novel immunotherapy combinations.
- Findings may inform future treatment paradigms for patients with previously-treated, recurrent/metastatic cervical cancer.
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