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RecruitingNCT07472153Updated May 28, 2026

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

A Phase 2/3 interventional study of PD-1 antibody and PD-L1 antibody in Metastatic Cervical Cancer, Persistent Cervical Cancer and Recurrent Cervical Cancer, sponsored by N.N. Alexandrov National Cancer Centre. Recruiting at 1 site in Belarus. Open to female participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2026-05-28.

Sponsored by N.N. Alexandrov National Cancer Centre · Phase 2/3, Interventional, and Treatment

From the registry’s dates

  • Registered 8 months after the study started (first participant enrolled Jul 2025, registered Mar 2026).
  • Started Jul 2025; still recruiting 1 year 4 months later.
Phase
Phase 2/3
Study type
Interventional
Enrollment
120
Allocation
Randomized
Ages
18 Years to 75 Years
Sex
Female
01

Study 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.

02

Conditions studied

  • Metastatic Cervical Cancer
  • Persistent Cervical Cancer
  • Recurrent Cervical Cancer
03

In context

Uterine Cervical Neoplasms

2,366 studies on the registry are indexed under Uterine Cervical Neoplasms; 677 are open to participants now.

This study's planned enrollment of 120 is above the median of 100 across 1,738 interventional studies indexed under Uterine Cervical Neoplasms.

Browse Uterine Cervical Neoplasms studies →

Lead sponsor

N.N. Alexandrov National Cancer Centre is the lead sponsor of 5 studies on the registry; 5 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 75 Years
Sexes eligible
Female
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Age ≥18-≤75 years.
  • confirmed diagnosis.
  • One of the forms of the cervical cancer:

    1. 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.
  • (ECOG) performance status of 0 or 1.
  • No to chemotherapy, immunotherapy, or bevacizumab.
  • Signed to participate in the study.

Exclusion criteria

Exclusion Criteria:

  • Presence of another active malignant invasive neoplasm.
  • Pregnancy or lactation period.
Terms in these criteria, in plain language(5)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Histologically or cytologically confirmed

The diagnosis was confirmed by looking at a sample under a microscope: tissue from a biopsy or surgery (histology), or cells from a fluid or needle sample (cytology).

Your pathology report is the document that shows this.

Metastases

Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.

ECOG performance status

A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.

0
Fully active, no restrictions.
1
Limited in strenuous activity, but walking and able to do light work, such as housework or office work.
2
Walking and able to look after yourself, but unable to work; up and about more than half of waking hours.
3
Able to look after yourself only in part; in bed or a chair more than half of waking hours.
4
Unable to look after yourself at all; in bed or a chair all day.

Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.

Contraindication

A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

05

Study design

Phase
Phase 2 / Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Participant)
Enrollment
120 participants (estimated)

Study arms

  • Experimental
    PD-1

    Drug: PD-1 antibody

  • Experimental
    PD-L1

    Drug: PD-L1 antibody

  • Active comparator
    Standard

    Drug: Chemotherapy and bevacizumab (CT-BEV)

Interventions

  • 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.

  • DrugPD-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.

  • DrugChemotherapy and bevacizumab (CT-BEV)

    Drug page: Bevacizumab

    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.

06

What researchers measure

Primary outcomes

  1. Overall survival

    Time from randomization to the death of any cause

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

  2. Median overall survival

    The timepoint at which 50% of patients are still alive following treatment initiation

    Time frame: From date of treatment initiation until the date of death from any cause, assessed up to 36 months

Secondary outcomes

  1. Objective response rate

    The percentage of patients whose cancer shrinks or disappears (complete or partial response) after treatment

    Time frame: From randomization until progression or study completion, average of 60 months

  2. Duration of response

    The length of time from the first sign of a treatment response (partial or complete) until disease progression or death

    Time frame: From date of first documented response until progression or death, assessed up to 60 months

  3. Disease-free survival

    Time from randomization to any sign or symptom of the cancer or death from the disease

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

  4. Median Disease-free survival

    The time at which 50% of patients remain alive without any signs or symptoms of cancer

    Time frame: From date of treatment initiation until the date of death from any cause, assessed up to 36 months

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

07

Study locations

1 of 1 sites recruiting
08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 28, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07472153
Lead sponsor
N.N. Alexandrov National Cancer Centre
Responsible party
Sponsor
First posted
Mar 16, 2026
Start date
Jul 1, 2025
Primary completion
Jun 30, 2030 (estimated)
Completion
Jun 30, 2033 (estimated)
Last update
May 28, 2026

Study contacts

Yana Kamko
Contact
kazache.yana@gmail.com
80259111218
Sergey Mavrichev
Contact
smavrichev71@gmail.com

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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Studies of the drug tested here: Immune checkpoint inhibitors

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