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

May 26, 2026 updated by: N.N. Alexandrov National Cancer Centre

To Validate, Develop and Implement The Scope of Medical Care for Metastatic, Persistent and Recurrent Cervical Cancer Using The Method of Chemoimmunotargeted Therapy

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

120

Phase

  • Phase 2
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Belarus
    • Lesnoy
      • Minsk, Lesnoy, Belarus, 223040
        • Recruiting
        • N.N. Alexandrov National Caner Centre
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Standard
Drug: Chemotherapy and bevacizumab (CT-BEV)
Patients will receive 6 courses of chemotherapy according to the regimen of cisplatin 75 mg/m2 or carboplatin AUC 5-6 + paclitaxel 175 mg/m2 ± bevacizumab 7-10 mg/kg every 21 days. In case of a complete or partial response or stabilization maintenance therapy is carried out until disease progression or intolerable toxicity of bevacizumab 7-10 mg/kg every 21 days.
Experimental: PD-1
Drug: PD-1 antibody
Patients will receive 6 courses of chemotherapy according to the regimen of cisplatin 75 mg/m2 or carboplatin AUC 5-6 + paclitaxel 175 mg/m2 + PD-1 inhibitor ± bevacizumab 7-10 mg/kg every 21 days. In case of a complete or partial response or stabilization maintenance therapy is carried out until disease progression or intolerable toxicity of treatment according to the regimen of PD-1 inhibitor ± bevacizumab 7-10 mg/kg every 21 days.
Experimental: PD-L1
Drug: PD-L1 antibody
Patients will receive 6 courses of chemotherapy according to the regimen of cisplatin 75 mg/m2 or carboplatin AUC 5-6 + paclitaxel 175 mg/m2 + PD-L1 inhibitor ± bevacizumab 7-10 mg/kg every 21 days. In case of a complete or partial response or stabilization maintenance therapy is carried out until disease progression or intolerable toxicity of treatment according to the regimen of PD-L1 inhibitor ± bevacizumab 7-10 mg/kg every 21 days.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Overall survival
Time Frame: From enrollment through study completion, an average of 2 year
Time from randomization to the death of any cause
From enrollment through study completion, an average of 2 year
Median overall survival
Time Frame: From date of treatment initiation until the date of death from any cause, assessed up to 36 months
The timepoint at which 50% of patients are still alive following treatment initiation
From date of treatment initiation until the date of death from any cause, assessed up to 36 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Objective response rate
Time Frame: From randomization until progression or study completion, average of 60 months
The percentage of patients whose cancer shrinks or disappears (complete or partial response) after treatment
From randomization until progression or study completion, average of 60 months
Duration of response
Time Frame: From date of first documented response until progression or death, assessed up to 60 months
The length of time from the first sign of a treatment response (partial or complete) until disease progression or death
From date of first documented response until progression or death, assessed up to 60 months
Disease-free survival
Time Frame: From enrollment through study completion, an average of 2 year
Time from randomization to any sign or symptom of the cancer or death from the disease
From enrollment through study completion, an average of 2 year
Median Disease-free survival
Time Frame: From date of treatment initiation until the date of death from any cause, assessed up to 36 months
The time at which 50% of patients remain alive without any signs or symptoms of cancer
From date of treatment initiation until the date of death from any cause, assessed up to 36 months

Other Outcome Measures

Outcome Measure
Time Frame
The frequency of immune-related adverse events
Time Frame: Through From date of first immunotherapy dose through 60 months, or date of last patient contact
Through From date of first immunotherapy dose through 60 months, or date of last patient contact
The frequency of discontinuation of immunotherapy
Time Frame: From date of first immunotherapy dose through 60 months, or date of last patient contact
From date of first immunotherapy dose through 60 months, or date of last patient contact

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

N.N. Alexandrov National Cancer Centre

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 1, 2025

Primary Completion (Estimated)

June 30, 2030

Study Completion (Estimated)

June 30, 2033

Study Registration Dates

First Submitted

March 2, 2026

First Submitted That Met QC Criteria

March 11, 2026

First Posted (Actual)

March 16, 2026

Study Record Updates

Last Update Posted (Actual)

May 28, 2026

Last Update Submitted That Met QC Criteria

May 26, 2026

Last Verified

May 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 20260013

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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