NCT07472153

PD-1 (Programmed Death-1) Versus PD-L1 (Programmed Death-ligand 1) Immune Check Point Inhibitors Combined With Chemotherapy, With or Without Bevacizumab, In Patients With Metastatic, Persistent Or Recurrent Cervical Cancer

To Validate, Develop and Implement The Scope of Medical Care for Metastatic, Persistent and Recurrent Cervical Cancer Using The Method of Chemoimmunotargeted Therapy

• Status: Recruiting
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 120 (estimated)
• Sponsor: N.N. Alexandrov National Cancer Centre · Other Government
• Sex: Female
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

This is a randomized trial evaluating the results of using of PD-1 and PD-L1 immune checkpoint inhibitors combined with chemotherapy, with or without bevacizumab, in patients with metastatic, persistent, and recurrent cervical cancer.

Conditions

• Metastatic Cervical Cancer
• Persistent Cervical Cancer
• Recurrent Cervical Cancer

Interventions

Type	Name	Description
DRUG	PD-1 antibody	Patients will receive 6 courses of chemotherapy according to the regimen of cisplatin 75 mg/m2 or carboplatin AUC 5-6 + paclitaxel 175 mg/m2 + PD-1 inhibitor ± bevacizumab 7-10 mg/kg every 21 days. In case of a complete or partial response or stabilization maintenance therapy is carried out until disease progression or intolerable toxicity of treatment according to the regimen of PD-1 inhibitor ± bevacizumab 7-10 mg/kg every 21 days.
DRUG	PD-L1 antibody	Patients will receive 6 courses of chemotherapy according to the regimen of cisplatin 75 mg/m2 or carboplatin AUC 5-6 + paclitaxel 175 mg/m2 + PD-L1 inhibitor ± bevacizumab 7-10 mg/kg every 21 days. In case of a complete or partial response or stabilization maintenance therapy is carried out until disease progression or intolerable toxicity of treatment according to the regimen of PD-L1 inhibitor ± bevacizumab 7-10 mg/kg every 21 days.
DRUG	Chemotherapy and bevacizumab (CT-BEV)	Patients will receive 6 courses of chemotherapy according to the regimen of cisplatin 75 mg/m2 or carboplatin AUC 5-6 + paclitaxel 175 mg/m2 ± bevacizumab 7-10 mg/kg every 21 days. In case of a complete or partial response or stabilization maintenance therapy is carried out until disease progression or intolerable toxicity of bevacizumab 7-10 mg/kg every 21 days.

Timeline

• Start date: 2025-07-01
• Primary completion: 2030-06-30
• Completion: 2033-06-30
• First posted: 2026-03-16
• Last updated: 2026-03-16

Locations

1 site across 1 country: Belarus