Skip to main content
OpenTrials
Recruiting

NCT Number: NCT07472153

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

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.

Recruiting

Interested in participating?

Request Info

Key information

Conditions

Metastatic Cervical Cancer Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female Genital Neoplasms, Female Neoplasms Neoplasms by Site Persistent Cervical Cancer Recurrent Cervical Cancer Urogenital Diseases Urogenital Neoplasms Uterine Cervical Diseases Uterine Cervical Neoplasms Uterine Diseases Uterine Neoplasms

Age range

18 year–75 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 2 / Phase 3

Primary location

N.N. Alexandrov National Caner Centre

Minsk, Lesnoy, 223040, Belarus

Location status: Recruiting

Location contact

Yana Kamko

CONTACT

[email protected]

80259111218

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Age ≥18-≤75 years.
  • Histologically confirmed diagnosis.
  • One of the forms of the cervical cancer:
  • Metastatic cervical cancer (stage IVB according to FIGO (International Federation of Gynaecology and Obstetrics) 2018);
  • Persistent cervical cancer (primary incurability after radical treatment for stages IIB-IVA cervical cancer according to FIGO 2018);
  • 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.

Treatment and study plan

PD-1 antibody

Drug

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.

PD-L1 antibody

Drug

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.

Chemotherapy and bevacizumab (CT-BEV)

Drug

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.

Primary outcomes

  1. Overall survival

    Time frame: From enrollment through study completion, an average of 2 year

    Time from randomization to the death of any cause

  2. 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

Secondary outcomes

  1. 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

  2. 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

  3. 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

  4. 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

Other outcomes

  1. 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

  2. The frequency of discontinuation of immunotherapy

    Time frame: From date of first immunotherapy dose through 60 months, or date of last patient contact

Study contacts

Contact information is provided by the study sponsor or research team.

Sergey Mavrichev

CONTACT

[email protected]

Yana Kamko

CONTACT

[email protected]

80259111218

Sponsors and collaborators

Lead sponsor

N.N. Alexandrov National Cancer Centre

Other Gov

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2030
Study completion
2033
First posted
Mar 16, 2026
Registry last updated
May 28, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.