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.