RecruitingPhase 2Phase 3NCT07472153

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

Sponsor

N.N. Alexandrov National Cancer Centre

Enrollment

120 participants

Start Date

Jul 1, 2025

Study Type

INTERVENTIONAL

Conditions

Recurrent Cervical Cancer Metastatic Cervical Cancer Persistent Cervical Cancer

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.

Eligibility

Sex: FEMALEMin Age: 18 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This trial is testing different combinations of immunotherapy drugs (called PD-1 and PD-L1 inhibitors, which help the immune system fight cancer) together with chemotherapy, with or without a drug that blocks blood vessel growth (bevacizumab), in women with advanced cervical cancer. The goal is to find which combination works best. **You may be eligible if...** - You are between 18 and 75 years old - You have been confirmed to have cervical cancer that has spread to distant parts of the body, came back after treatment, or could not be fully cured with initial treatment - You are in good general health (able to carry out light activity) - Your tumor sample can be tested for a protein called PD-L1 **You may NOT be eligible if...** - You have another active cancer - You are pregnant or breastfeeding Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGPD-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.

DRUGPD-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.

DRUGChemotherapy 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.