Metastatic Cervical CancerPhase 2/3NCT07472153
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 study testing PD-1 antibody, PD-L1 antibody and Chemotherapy and bevacizumab (CT-BEV) in people with Metastatic Cervical Cancer and Persistent Cervical Cancer, run by N.N. Alexandrov National Cancer Centre at 1 site in Belarus.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years, women only
- Conditions the study is for
- Metastatic Cervical Cancer, Persistent Cervical Cancer, Recurrent Cervical Cancer
- What is being tested?
- PD-1 antibody, PD-L1 antibody and Chemotherapy and bevacizumab (CT-BEV)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteBelarus
- Study dates
- 1 Jul 2025to 30 Jun 2033
- Phase
- Phase 2/3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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).
Show all 10Show fewer
- 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.
Who cannot join
- Presence of another active malignant invasive neoplasm.
- Pregnancy or lactation period.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Sergey Mavrichev contact
Belarus1 site, 1 recruiting
- Recruiting
N.N. Alexandrov National Caner Centre
Minsk, Lesnoy, 223040
Yana Kamko, 80259111218, kazache.yana@gmail.com
About this study
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
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.
- Being tested
- PD-1 antibody, PD-L1 antibody, Chemotherapy and bevacizumab (CT-BEV)
- Medical subject headings
- Uterine Cervical Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PD-1 antibodyDrug
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 antibodyDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| PD-1 | Experimental | Not described Receives: Drug: PD-1 antibody |
| PD-L1 | Experimental | Not described Receives: Drug: PD-L1 antibody |
| Standard | Active comparator | Not described Receives: Drug: Chemotherapy and bevacizumab (CT-BEV) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall survival
Time from randomization to the death of any cause
Measured: 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
Measured: From date of treatment initiation until the date of death from any cause, assessed up to 36 months
Secondary outcomes (4)
Objective response rate
The percentage of patients whose cancer shrinks or disappears (complete or partial response) after treatment
Measured: 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
Measured: 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
Measured: 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
Measured: From date of treatment initiation until the date of death from any cause, assessed up to 36 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Mar 2026
- Study start1 Jul 2025
- Primary completion30 Jun 2030 (estimated)
- Study completion30 Jun 2033 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Metastatic Cervical CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- N.N. Alexandrov National Cancer Centre
- Sponsor type
- Other government
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07472153
- Sponsor's protocol ID
- 20260013
- Status last verified
- May 2026
- First submitted
- 2 Mar 2026
- Last updated
- 28 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 28 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT07472153
- Acronym / sponsor ID
- 20260013
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- N.N. Alexandrov National Cancer CentreOther government
- Study start
- 1 Jul 2025 (actual)
- Primary completion
- 30 Jun 2030 (estimated)
- Study completion
- 30 Jun 2033 (estimated)
- First posted
- 16 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| PD-1 | Experimental | Drug: PD-1 antibody |
| PD-L1 | Experimental | Drug: PD-L1 antibody |
| Standard | Active comparator | Drug: Chemotherapy and bevacizumab (CT-BEV) |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Age ≥18-≤75 years.
- Histologically confirmed diagnosis.
- One of the forms of the cervical cancer:
- Availability of material for determining PD-L-1 expression for immunotherapy candidates.
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
Key exclusion criteria (2 listed)
- Presence of another active malignant invasive neoplasm.
- Pregnancy or lactation period.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PD-1 antibodyPatients 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. | Drug | PD-1 |
| PD-L1 antibodyPatients 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. | Drug | PD-L1 |
| 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. | Drug | Standard |
Primary outcome
Overall survival
Time frame: From enrollment through study completion, an average of 2 year
Time from randomization to the death of any cause
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
4 secondary outcomes
Objective response rate
Time frame: 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
Disease-free survival
Time frame: 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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 May 2026.
- Individual participant dataSharing planned: Undecided
Related trials for Metastatic Cervical Cancer
RecruitingPhase 1/2
Docetaxel and SX-682 in Recurrent/Metastatic Head and Neck Squamous Cell Carcinoma, Salivary Gland Carcinoma, and Advanced Prostate Cancer
Head and Neck Cancer, Head and Neck Squamous Cell Carcinoma
RecruitingPhase 1
A Study of LY4257496 in Participants With Cancer (OMNIRAY)
Breast Neoplasms, Colorectal Neoplasms
RecruitingPhase 2
A Study Investigating Alternate Schedules of Tislelizumab Plus Chemotherapy in Japanese Patients With First-line Advanced ESCC
Advanced Esophageal Squamous Cell Carcinoma, Metastatic Esophageal Squamous Cell Carcinoma
Not yet recruitingPhase 1/2
177Lu-DOTA-EB-TATE in Adult Patients With Metastatic, Radioactive Iodine Non-Responsive Oncocytic (Hurthle-Cell) Thyroid Cancer
Thyroid Cancer
RecruitingPhase 2
Testing the Addition of BMS-986016 (Relatlimab) to the Usual Immunotherapy After Initial Treatment for Recurrent or Metastatic Nasopharyngeal Cancer
Metastatic Nasopharyngeal Carcinoma, Recurrent Nasopharyngeal Carcinoma
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Sergey Mavrichev contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing PD-1 antibody, PD-L1 antibody and Chemotherapy and bevacizumab (CT-BEV) in people with Metastatic Cervical Cancer and Persistent Cervical Cancer, run by N.N. Alexandrov National Cancer Centre at 1 site in Belarus.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 28 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belarus. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Yana Kamko (80259111218, kazache.yana@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall survival (time frame: From enrollment through study completion, an average of 2 year). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 May 2026.