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

Официальное название

To Validate, Develop and Implement The Scope of Medical Care for Metastatic, Persistent and Recurrent Cervical Cancer Using The Method of Chemoimmunotargeted Therapy

Обзор

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.

Вмешательства

• Препарат 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.
• Препарат 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.
• Препарат 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.

Первичные конечные точки

• Overall survival [Срок оценки: From enrollment through study completion, an average of 2 year]
• Median overall survival [Срок оценки: From date of treatment initiation until the date of death from any cause, assessed up to 36 months]

Вторичные конечные точки (4)

• Objective response rate [Срок оценки: From randomization until progression or study completion, average of 60 months]
• Duration of response [Срок оценки: From date of first documented response until progression or death, assessed up to 60 months]
• Disease-free survival [Срок оценки: From enrollment through study completion, an average of 2 year]
• Median Disease-free survival [Срок оценки: From date of treatment initiation until the date of death from any cause, assessed up to 36 months]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• Presence of another active malignant invasive neoplasm.
• Pregnancy or lactation period.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Простое слепое

Основная цель

Лечение

Центры проведения

Беларусь · 1 центр

• N.N. Alexandrov National Caner Centre — Minsk

Идентификаторы

NCT: NCT07472153 · 20260013

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗