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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| PD-1 | Experimental |
| |
| PD-L1 | Experimental |
| |
| Standard | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PD-1 antibody | 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 + 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. |
| Measure | Description | Time 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 |
| Measure | Description | Time 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 |
| Measure | Description | Time Frame |
|---|---|---|
| The frequency of immune-related adverse events | Through From date of first immunotherapy dose through 60 months, or date of last patient contact | |
| The frequency of discontinuation of immunotherapy | From date of first immunotherapy dose through 60 months, or date of last patient contact |
Inclusion Criteria:
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.
No contraindications to chemotherapy, immunotherapy, or bevacizumab.
Signed informed consent to participate in the study.
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Yana Kamko | Contact | 80259111218 | kazache.yana@gmail.com | |
| Sergey Mavrichev | Contact | smavrichev71@gmail.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| N.N. Alexandrov National Caner Centre | Recruiting | Minsk | Lesnoy | 223040 | Belarus |
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|
| PD-L1 antibody | 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 + 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. |
|
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 |
| ID | Term |
|---|---|
| D002583 | Uterine Cervical Neoplasms |
| ID | Term |
|---|---|
| D014594 | Uterine Neoplasms |
| D005833 | Genital Neoplasms, Female |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D002577 | Uterine Cervical Diseases |
| D014591 | Uterine Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D000091662 | Genital Diseases |
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| ID | Term |
|---|---|
| C000711728 | spartalizumab |
| D004358 | Drug Therapy |
| D000068258 | Bevacizumab |
| ID | Term |
|---|---|
| D013812 | Therapeutics |
| D061067 | Antibodies, Monoclonal, Humanized |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
| D007162 | Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |
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