Introduction Treatment options for refractory, recurrent, or metastatic cervical cancer (R/M CC) are limited. This study evaluated the efficacy and safety of toripalimab combined with bevacizumab and platinum-based chemotherapy as first-line treatment for refractory R/M CC.

Methods Patients (≥18 years) who had no prior systemic treatment with histologically confirmed refractory R/M CC were eligible. Patients received toripalimab (240 mg, D1, q3W) plus bevacizumab (7.5 mg/kg, D1, q3W) and platinum-based chemotherapy (paclitaxel 175 mg/m²+ cisplatin 50 mg/m² or carboplatin AUC=5, D1, q3W) for 6 cycles, followed by the maintenance of toripalimab plus bevacizumab (q3W) for 12 months or until disease progression or intolerable toxicity occurred. The primary endpoint was the objective response rate (ORR) per RECIST v1.1. The secondary endpoints were safety profiles, disease control rate (DCR), progression-free survival (PFS), and overall survival (OS).

Results A total of 23 patients were in the final analysis. The median follow-up duration was 9.6 months (95% CI, 6.4 to 12.8). The ORR was 78.3% (95% CI, 56.3 to 92.5), 1 (4.3%) patient achieved CR and 17 (73.9%) attained PR. The DCR was 91.3% (95% CI, 72 to 98.9). The median PFS and OS were not reached. Any grade treatment-related adverse events (TRAEs) occurred in 91.7% of patients, and the most common were neutropenia (58.3%), ATCH increased (37.5%), and anemia (37.5%). The grade ≥ 3 TRAEs occurred in 58.3%. No grade ≥ 3 irAEs occurred.

Conclusion/Implications Toripalimab combined with bevacizumab and platinum-based chemotherapy has demonstrated promising clinical efficacy as the first-line treatment for patients with refractory R/M CC while showing a tolerable safety profile.