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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

NCT07472153

RecruitingPhase 2, Phase 3

Sponsor: N.N. Alexandrov National Cancer Centre

Conditions: Metastatic Cervical Cancer, Persistent Cervical Cancer, Recurrent Cervical Cancer

Interventions: PD-1 antibody, PD-L1 antibody, Chemotherapy and bevacizumab (CT-BEV)

Countries: Belarus

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 overview

Sex: FEMALE

Age: 18 Years to 75 Years

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility 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.

Locations (1)

Minsk, Lesnoy, Belarus