IBI310 plus sintilimab vs. placebo plus sintilimab in recurrent/metastatic cervical cancer: A double-blind, randomized controlled trial

作者：Huayi Li, Yancheng Xu, Xiaofei Jiao, Xu Qin, Zikun Peng, Ying Tang, Jieqing Zhang, Bowen Huang, Yiyang Shen, Baoping Chang, Bairong Xia, Wei Duan, Danbo Wang, Lijing Zhu, R. An, Guonan Zhang, Ya‐ling Tang, Jian-Li Huang, Hui Qiu, Li Wang, Yi Huang, Guiling Li, Jianhua Qian, Li Sun, Hong Zheng, Ge Lou, Youzhong Zhang, Youguo Chen, Liqin Lu, Yan Cheng, Jihong Liu, Weidong Zhao, Jianghai Ji, Aiqin He, Ke Wang, Guohua Yu, Hong Zhu, Cailing Ma, Jianlin Yuan, Xia Wang, Hongfei Zhang, Xinyan Ma, Chujun Cai, Kang Yin, Han Xie, Ya Wang, Shuyan Wang, Li Li, Hui Zhou, Jing Wang, Jianqing Zhu, Ding Ma, Qinglei Gao · 发表于：Med · 年份：2025 · DOI：10.1016/j.medj.2024.100573 · 被引用次数：7 · 研究领域：Endometrial and Cervical Cancer Treatments、Cancer Immunotherapy and Biomarkers、Colorectal and Anal Carcinomas

BACKGROUND: It remains unclear whether adding CTLA-4 blockade to PD-1/PD-L1 blockade improves clinical outcomes in cervical cancer (CC). METHODS: In this randomized, double-blind, placebo-controlled, phase 2 study (ClinicalTrials.gov: NCT04590599), patients with recurrent/metastatic CC (R/M CC) who experienced disease progression after or during platinum-based chemotherapy were enrolled from 37 centers across China and randomly assigned (1:1), stratified by PD-L1 expression and prior treatment lines, to receive either IBI310 plus sintilimab or placebo plus sintilimab intravenously every 3 weeks for 12 weeks, followed by sintilimab alone. The primary endpoint was the objective response rate (ORR). Pivotal secondary endpoints included progression-free survival (PFS), overall survival (OS), and safety. FINDINGS: 205 patients were randomized to receive IBI310-sintilimab (n = 103) or placebo-sintilimab (n = 102). The ORR difference between the IBI310-sintilimab arm (32.3%, 95% confidence interval [CI]: 23.3%-42.5%) and the placebo-sintilimab arm (23.5%, 95% CI: 15.5%-33.1%) was not significant (p = 0.17). IBI310-sintilimab and placebo-sintilimab exhibited median PFS values of 3.6 (95% CI: 2.7-6.3) and 4.2 months (95% CI: 2.8-6.2), respectively (hazard ratio [HR] = 0.91, 95% CI: 0.65-1.27; p = 0.58). The median OSs were 13.9 months (95% CI: 11.5-25.6) in the IBI310-sintilimab arm and 17.2 months (95% CI: 13.7-25.9) in the placebo-sintilimab arm (HR = 1.12, 95% CI: 0.79-1.58; p = 0....