Recruiting 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
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: PD-1 antibody, PD-L1 antibody, Chemotherapy and bevacizumab (CT-BEV).
- Who it may be relevant to
- Registry conditions: Metastatic Cervical Cancer, Persistent Cervical Cancer, Recurrent Cervical Cancer. Basic parameters: 18 years — 75 years · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Belarus
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
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
Overview
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.
Interventions
- 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. - 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. - 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.
Primary outcome measures
- Overall survival [Time frame: 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]
Secondary outcome measures (4)
- 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]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Single blind
- Primary purpose
- Treatment
Study locations
Belarus · 1 center
- N.N. Alexandrov National Caner Centre — Minsk
Identifiers
NCT: NCT07472153 · 20260013