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Clinical Trial NCT07472153 for Metastatic Cervical Cancer, Persistent Cervical Cancer, Recurrent Cervical Cancer is recruiting. See the Trial Radar Card View and AI discovery tools for all the details. Or ask anything here.
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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 Phase 2, Phase 3 120 Randomized

Recruiting
Clinical Trial NCT07472153 is designed to study Treatment for Metastatic Cervical Cancer, Persistent Cervical Cancer, Recurrent Cervical Cancer. It is a Phase 2 Phase 3 interventional study that is recruiting, having started on 1 July 2025, with plans to enroll 120 participants. Led by N.N. Alexandrov National Cancer Centre, it is expected to complete by 30 June 2033. The latest data from ClinicalTrials.gov was last updated on 16 March 2026.
Brief 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.
Official Title

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

Conditions
Metastatic Cervical CancerPersistent Cervical CancerRecurrent Cervical Cancer
Other Study IDs
  • 20260013
NCT ID Number
NCT07472153
Start Date (Actual)
2025-07-01
Last Update Posted
2026-03-16
Completion Date (Estimated)
2033-06-30
Enrollment (Estimated)
120
Study Type
Interventional
PHASE
Phase 2
Phase 3
Status
Recruiting
Primary Purpose
Treatment
Design Allocation
Randomized
Interventional Model
Parallel
Masking
Single
Arms / Interventions
Participant Group/ArmIntervention/Treatment
ExperimentalPD-1
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/...Show More
ExperimentalPD-L1
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 m...Show More
Active ComparatorStandard
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.
Primary Outcome Measures
Outcome MeasureMeasure DescriptionTime Frame
Overall survival
Time from randomization to the death of any cause
From enrollment through study completion, an average of 2 year
Median overall survival
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 MeasureMeasure DescriptionTime Frame
Objective response rate
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
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 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
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
Participation Assistant
Eligibility Criteria

Eligible Ages
Adult, Older Adult
Minimum Age
18 Years
Eligible Sexes
Female

  • 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.

  • Presence of another active malignant invasive neoplasm.
  • Pregnancy or lactation period.
N.N. Alexandrov National Cancer Centre logoN.N. Alexandrov National Cancer Centre
Study Central Contact
Contact: Yana Kamko, 80259111218, [email protected]
Contact: Sergey Mavrichev, [email protected]
1 Study Locations in 1 Countries

Lesnoy

N.N. Alexandrov National Caner Centre, Minsk, Lesnoy, 223040, Belarus
Yana Kamko, Contact, 80259111218, [email protected]
Recruiting