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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
RECRUITINGPhase 2/3Sponsored by N.N. Alexandrov National Cancer Centre
Actively Recruiting
PhasePhase 2/3
SponsorN.N. Alexandrov National Cancer Centre
Started2025-07-01
Est. completion2030-06-30
Eligibility
Age18 Years – 75 Years
SexFEMALE
Healthy vol.Accepted
View on ClinicalTrials.gov →
NCT07472153
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
Age: 18 Years – 75 YearsSex: FEMALEHealthy volunteers accepted
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.
Conditions4
CancerMetastatic Cervical CancerPersistent Cervical CancerRecurrent Cervical Cancer
Interventions3
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Actively Recruiting
PhasePhase 2/3
SponsorN.N. Alexandrov National Cancer Centre
Started2025-07-01
Est. completion2030-06-30
Eligibility
Age18 Years – 75 Years
SexFEMALE
Healthy vol.Accepted
View on ClinicalTrials.gov →
NCT07472153