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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
120
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.
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.
N.N. Alexandrov National Caner Centre
Minsk, Lesnoy, Belarus
RECRUITINGOverall survival
Time from randomization to the death of any cause
Time frame: 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
Time frame: From date of treatment initiation until the date of death from any cause, assessed up to 36 months
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
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
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
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
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