Multicenter phase 2 trial of sintilimab plus HPV vaccine for recurrent or metastatic cervical cancer

Patients with recurrent or metastatic cervical cancer (R/M CC) after failure of first-line therapy have limited treatment options. A multicenter phase 2 trial in China evaluated the combination of sintilimab (anti-PD-1) with a prophylactic HPV quadrivalent vaccine as second-line treatment for these patients. Patients received sinitilimab every 3 weeks for up to 24 months and 3 doses of the vaccine (first dose before start of sintilimab, subsequent doses after 2 and 6 months). Among 13 enrolled patients, the objective response rate was 53.8% (95% CI 25.1-80.8) and the disease control rate was 76.9% (46.2-95.0). Median progression-free survival was 7.16 months (95% CI 1.91-NA) and median overall survival was not reached (9.89-NA) during median 16.07 months of follow-up. Hypothyroidism (15.6% of patients) was the most common treatment-related adverse event; there were no grade 3 or higher TRAEs. The authors conclude that 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.