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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

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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