PD-1 versus PD-L1 immunotherapy combined with chemotherapy, with or without bevacizumab, for advanced 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
This trial tests whether giving PD-1 or PD-L1 immunotherapy alongside chemotherapy, with or without bevacizumab, helps adults with metastatic, persistent, or recurrent cervical cancer.
Quick facts
| Phase | Phase2; Phase3 |
|---|---|
| Study type | Interventional |
| Enrollment | 120 (estimated) |
| Ages | 18 Years to 75 Years |
| Sex | Female |
| Sponsor | N.N. Alexandrov National Cancer Centre Government |
| Drugs / interventions | bevacizumab, chemotherapy, immunotherapy |
| Locations | 1 site (Minsk, Lesnoy) |
| Trial ID | NCT07472153 on ClinicalTrials.gov |
What this trial studies
This randomized phase 2/3 trial compares a PD-1 antibody versus a PD-L1 antibody each given with standard chemotherapy, with the option of adding bevacizumab, in adults with metastatic, persistent, or recurrent cervical cancer. Participants must have histologically confirmed disease, ECOG performance status 0–1, and available tissue for PD-L1 testing. Key exclusions include another active invasive malignancy and pregnancy or lactation. The trial is being run at the N.N. Alexandrov National Cancer Centre in Minsk and follows standard safety and efficacy monitoring for immunotherapy and chemotherapy combinations.
Who should consider this trial
Good fit: Adults aged 18–75 with histologically confirmed metastatic, persistent, or recurrent cervical cancer, ECOG 0–1, no contraindications to chemotherapy/immunotherapy/bevacizumab, and available tissue for PD-L1 testing.
Not a fit: Patients with another active invasive cancer, those who are pregnant or breastfeeding, or those with poor performance status or contraindications to the study drugs are unlikely to benefit from participation.
Why it matters
Potential benefit: If successful, the regimen could improve response rates and prolong progression-free and overall survival for some patients with advanced cervical cancer.
How similar studies have performed: Previous trials of PD-1/PD-L1 inhibitors have shown activity in cervical cancer—leading to approvals for PD-1 agents in certain PD-L1–positive patients—while direct head-to-head comparisons of PD-1 versus PD-L1 agents remain limited.
Eligibility criteria
Show full inclusion / exclusion criteria
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.
Where this trial is running
Minsk, Lesnoy
- N.N. Alexandrov National Caner Centre — Minsk, Lesnoy, Belarus (Recruiting)
Study contacts
- Study coordinator: Yana Kamko
- Email: kazache.yana@gmail.com
- Phone: 80259111218
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.