RaPiDS (GOG-3028): randomized Phase II study of balstilimab alone or in combination with zalifrelimab in cervical cancer.
David M O'MalleyLeslie M RandallCamille Gunderson JacksonRobert L ColemanJohn L HaysKathleen M MooreR Wendel NaumannRodney P RocconiBrian M SlomovitzKrishnansu S TewariMarek AncukiewiczWaldo Ortuzar FeliuBradley J MonkPublished in: Future oncology (London, England) (2021)
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.
Keyphrases
- phase ii study
- open label
- placebo controlled
- phase ii
- free survival
- double blind
- phase iii
- locally advanced
- clinical trial
- end stage renal disease
- newly diagnosed
- study protocol
- chronic kidney disease
- squamous cell carcinoma
- ejection fraction
- dna damage
- prognostic factors
- peritoneal dialysis
- randomized controlled trial
- patient reported outcomes
- radiation therapy
- type diabetes
- oxidative stress
- combination therapy
- skeletal muscle
- weight loss
- replacement therapy