Purpose: Immune checkpoint inhibitors (ICIs) have been potential treatment option for patients with cervical cancer in several clinical studies. We investigated the safety and efficacy of cadonilimab, a bispecific antibody targeting PD-1 and CTLA-4, plus standard therapy for the first-line treatment of R/M CC. Patients and Methods: Eligible patients were assigned to 3 cohorts: cohort A-15 (cadonilimab 15mg/kg every 3 weeks (Q3W) plus chemotherapy), cohort A-10 (cadonilimb 10mg/kg Q3W plus chemotherapy), and cohort B-10 (cadonilimab 10mg/kg Q3W plus chemotherapy and bevacizumab). They received the corresponding treatments until disease progression, unacceptable toxicity, withdrawal of consent, or investigator decision. The primary objective was safety, the secondary endpoints included objective overall response (ORR), duration of response (DoR), disease control rate (DCR), progression free survival (PFS), and overall survival (OS). This study is registered with ClinicalTrials.gov (NCT04868708). Results: As of Feburary 13, 2023, treatment-related adverse events (TRAEs) occurred in 45 (100·0%) patients. Grade ≥3 TRAEs were reported in 33 (73·3%) patients. Immune-related adverse events (irAEs) occurred in 29 (64·4%) patients and grade ≥3 irAEs were observed in 9 (20·0%) patients. 7 (15·6%) of 45 patients permanently discontinued cadonilimab treatment due to TRAEs. One death due to hemorrhagic shock occurred in cohort B-10. Among 44 patients underwent at least one post-baseline tumor assessment, the ORR was 66·7% in cohort A-15, 68·8% in cohort A-10, 92·3% in cohort B-10, and 79·3% in cohortA-10 and cohort B-10 combined. Conclusions: Cadonilimab combined with standard therapy was acceptable, with encouraging antitumor activity in patients with R/M CC.

中文翻译：

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卡多尼利单抗联合化疗（加或不加贝伐珠单抗）作为复发或转移性宫颈癌的一线治疗 (COMPASSION-13)：一项 2 期研究

目的：在多项临床研究中，免疫检查点抑制剂（ICIs）已成为宫颈癌患者的潜在治疗选择。我们研究了卡多利单抗（一种针对 PD-1 和 CTLA-4 的双特异性抗体）以及标准疗法用于 R/M CC 一线治疗的安全性和有效性。患者和方法：符合条件的患者被分配到 3 个队列：队列 A-15（cadonilimab 15mg/kg 每 3 周（Q3W）加化疗）、队列 A-10（cadonilimab 10mg/kg Q3W 加化疗）和队列 B-10 （卡多尼单抗 10mg/kg Q3W 加化疗和贝伐珠单抗）。他们接受相应的治疗，直到疾病进展、出现不可接受的毒性、撤回同意或研究者决定。主要目标是安全性，次要终点包括客观总体缓解（ORR）、缓解持续时间（DoR）、疾病控制率（DCR）、无进展生存（PFS）和总体生存（OS）。本研究已在 ClinicalTrials.gov 注册（NCT04868708）。结果：截至2023年2月13日，45名（100·0%）患者发生治疗相关不良事件（TRAE）。33 名（73·3%）患者报告了≥3 级TRAE。29 名患者 (64·4%) 发生了免疫相关不良事件 (irAE)，9 名 (20·0%) 名患者观察到≥3 级的 irAE。45 名患者中有 7 名 (15·6%) 因 TRAE 永久停止卡多尼单抗治疗。B-10 队列中发生 1 例因失血性休克死亡。在 44 名患者中接受了至少一项基线后肿瘤评估，队列 A-15 中的 ORR 为 66·7%，队列 A-10 中为 68·8%，队列 B-10 中为 92·3%，队列 B-10 中为 79·3%队列 A-10 和队列 B-10 合计的百分比。结论：卡多尼利单抗联合标准治疗在 R/M CC 患者中是可接受的，具有令人鼓舞的抗肿瘤活性。