NCT05444374

A Phase II Study of Serplulimab Plus Bevacizumab in Combination With Chemotherapy in 1L Treatment of Untreated Recurrent or Metastatic Cervical Cancer

A Single-Arm, Multicenter, Phase II Study to Evaluate the Efficacy and Safety of Serplulimab Plus Bevacizumab in Combination With Chemotherapy in 1L Treatment of Patients With Untreated Recurrent or Metastatic Cervical Cancer

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 48 (estimated)
• Sponsor: Sichuan Cancer Hospital and Research Institute · Academic / Other
• Sex: Female
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

This study is a single-arm, multicenter, Phase II study to evaluate the efficacy and safety of the treatment of Serplulimab plus Bevacizumab in combination with chemotherapy in 1L treatment of patients with untreated recurrent or metastatic cervical cancer. Approximately 48 eligible subjects are planned to be enrolled across all sites. The dosing regimen is: Serplulimab plus Bevacizumab combined with chemotherapy (cisplatin, paclitaxel). Each cycle is 21 days (every 3 weeks). Subjects will receive Cisplatin plus Paclitaxel up to 4-6 cycles. The maximum duration of treatment with Serplulimab is 2 years (up to 35 cycles). During the study treatment period, the subjects will receive imaging examination and response assessments every 6 weeks (± 7 days) in the first 48 weeks, every 9 weeks (± 7 days) in 48-96 weeks, and then every 12 weeks (± 7 days). After the treatment discontinuation visit, the subjects will enter the safety follow-up period and survival follow-up period.

Conditions

• Cervical Cancer

Interventions

Type	Name	Description
DRUG	Serplulimab	Recombinant anti-PD-1 humanized monoclonal antibody injection
DRUG	Bevacizumab	Humanized anti-VEGF monoclonal antibody injection

Timeline

• Start date: 2022-10-01
• Primary completion: 2024-09-30
• Completion: 2025-12-31
• First posted: 2022-07-05
• Last updated: 2022-07-05

Locations

4 sites across 1 country: China