Sintilimab plus HPV vaccine for recurrent or metastatic cervical cancer
Buhai Wang, Yichen Liang, Yuechao Wu, Qiuxian Li, Yichun Zeng, Liqin Liu, Wenmiao Cao, Xiaoru Geng, Yuxiang Huang, Yinxia Wu, Jiulin Pan, Xian Zhang, Jingxu Gu
Abstract
PURPOSE: Recurrent or metastatic cervical cancer (r/m CC) presents limited treatment options for patients failed or progressed quickly following first-line therapy. This study investigated the potential of sintilimab with a prophylactic human papillomavirus (HPV) quadrivalent vaccine as a second-line treatment for r/m CC. METHODS: In this phase 2 clinical trial, patients with r/m CC previously unresponsive or intolerant to standard treatments for metastatic or recurrent lesions were enrolled. Participants received sintilimab (3 mg/kg for body weight <60 kg; 200 mg for ≥60 kg) every 3 weeks until 24 months or 35 cycles and 3 doses of the HPV quadrivalent vaccine (initial dose prior to sintilimab initiation, with subsequent doses at 2 and 6 months). The primary endpoint was the objective response rate (ORR). A Simon two-stage optimal design was used. RESULTS: From October 2019 to October 2022, 13 patients with r/m CC were enrolled. ORR achieved 53.8% (95% CI 25.1% to 80.8%), and the disease control rate was 76.9% (95% CI 46.2% to 95.0%). Median follow-up duration was 16.07 months (range: 3.64-48.2 months), and median progressive free survival was 7.16 months (95% CI 1.91 -not applicable (NA)). The median overall survival (OS) was not reached (95% CI 9.89 -NA). Hypothyroidism (15.6%) was the most common treatment-related adverse event (AE). No grade 3 or above AEs were observed. CONCLUSIONS: This study suggests the combination of sintilimab plus prophylactic HPV vaccine offers a potentially promising therapeutic strategy for patients with r/m CC unresponsive or intolerant to standard therapies.Trial registration numberNCT04096911.