RECRUITINGPhase 2 / Phase 3INTERVENTIONAL

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

About This Trial

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.

Who May Be Eligible (Plain English)

Who May Qualify: - Age ≥18-≤75 years. - diagnosed by tissue sample (biopsy-confirmed) diagnosis. - One of the forms of the cervical cancer: 1. Metastatic cervical cancer (stage IVB according to FIGO (International Federation of Gynaecology and Obstetrics) 2018); 2. Persistent cervical cancer (primary incurability after radical treatment for stages IIB-IVA cervical cancer according to FIGO 2018); 3. Reccurent cervical cancer (first recurrence after completed radical treatment for IA-IVB cervical cancer according to FIGO 2018). - Availability of material for determining PD-L-1 expression for immunotherapy candidates. - Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1. - No contraindications to chemotherapy, immunotherapy, or bevacizumab. - Signed willing to sign a consent form to participate in the study. Who Should NOT Join This Trial: - Presence of another active malignant invasive neoplasm. - Pregnancy or lactation period. Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language

Inclusion Criteria: * Age ≥18-≤75 years. * Histologically confirmed diagnosis. * One of the forms of the cervical cancer: 1. Metastatic cervical cancer (stage IVB according to FIGO (International Federation of Gynaecology and Obstetrics) 2018); 2. Persistent cervical cancer (primary incurability after radical treatment for stages IIB-IVA cervical cancer according to FIGO 2018); 3. Reccurent cervical cancer (first recurrence after completed radical treatment for IA-IVB cervical cancer according to FIGO 2018). * Availability of material for determining PD-L-1 expression for immunotherapy candidates. * Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1. * No contraindications to chemotherapy, immunotherapy, or bevacizumab. * Signed informed consent to participate in the study. Exclusion Criteria: * Presence of another active malignant invasive neoplasm. * Pregnancy or lactation period.

Treatments Being Tested

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.

Locations (1)

N.N. Alexandrov National Caner Centre

Minsk, Lesnoy, Belarus