Metastatic Cervical Cancer, Persistent Cervical Cancer, Recurrent Cervical Cancer
Conditions
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.
Interventions
DRUGPD-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.
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.
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.
Sponsors
N.N. Alexandrov National Cancer Centre
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* 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.
Exclusion criteria
* Presence of another active malignant invasive neoplasm. * Pregnancy or lactation period.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Overall survival | From enrollment through study completion, an average of 2 year | Time from randomization to the death of any cause |
| Median overall survival | 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
| Measure | Time frame | Description |
|---|---|---|
| Objective response rate | 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 |
| Duration of response | 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 |
| Disease-free survival | 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 |
| Median Disease-free survival | 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 |
Countries
Belarus
Contacts
CONTACTYana Kamko
CONTACTSergey Mavrichev
Outcome results
None listed