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

N.N. Alexandrov National Cancer Centre

Status and phase: Enrolling; Phase 3; Phase 2

Conditions: Metastatic Cervical Cancer; Persistent Cervical Cancer; Recurrent Cervical Cancer

Treatments: Drug: Chemotherapy and bevacizumab (CT-BEV); Drug: PD-1 antibody; Drug: PD-L1 antibody

Study type: Interventional

Funder types: Other

Identifiers

NCT07472153

20260013

Details and patient eligibility

About

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.

Enrollment: 120 estimated patients

Sex: Female

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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120 participants in 3 patient groups

PD-1

Experimental group

Treatment:

Drug: PD-1 antibody

PD-L1

Experimental group

Treatment:

Drug: PD-L1 antibody

Standard

Active Comparator group

Treatment:

Drug: Chemotherapy and bevacizumab (CT-BEV)