Division of Gynecologic Oncology, The Ohio State University/James Comprehensive Cancer Center, Columbus, OH 43210, USA.
Division of Gynecologic Oncology, Massey Cancer Center, Virginia Commonwealth University, Richmond, VA 23298, USA.
Future Oncol. 2021 Sep;17(26):3433-3443. doi: 10.2217/fon-2021-0529. Epub 2021 Aug 19.
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.
巴替利单抗（抗程序性死亡 1）和泽利利单抗（抗细胞毒性 T 淋巴细胞相关蛋白 4）是两种新的检查点抑制剂，作为治疗宫颈癌的有前途的研究药物而出现，特别是在先前治疗、复发/转移性疾病的情况下。在这里，我们描述了 RaPiDS（NCT03894215）的原理和设计，这是一项两臂 II 期研究，评估了巴替利单抗单药或联合泽利利单抗在一线铂类化疗后进展的晚期宫颈癌患者中的安全性、耐受性和疗效。患者将按 1:1 的比例随机分组。主要终点是客观缓解率，关键次要终点包括安全性、缓解持续时间、无进展生存期、总生存期和生活质量结果。
