NEoadjuvant Chemotherapy and Immunotherapy for a Selected Group of Inoperable Pleural Mesothelioma Patients (NECIM): a Feasibility Study

Обзор

The goal of this clinical trial is to evaluate whether a combination of chemotherapy and immunotherapy can make surgery possible in adults with inoperable pleural mesothelioma (a type of cancer affecting the lung lining). The main questions it aims to answer are: Can two cycles of neoadjuvant chemotherapy and dual immunotherapy, followed by surgery, be completed safely and effectively? Does this treatment allow previously inoperable patients to become eligible for surgery and improve survival outcomes? Participants will: Receive two cycles of chemotherapy (cisplatin or carboplatin and pemetrexed) Receive dual immunotherapy (nivolumab and ipilimumab) Undergo evaluation by a multidisciplinary team to determine if surgery is possible If operable, undergo extended pleurectomy/decortication surgery Be followed for one year to assess side effects, quality of life, and survival

Вмешательства

• Препарат Neoadjuvant chemo-immunotherapy
  Neoadjuvant chemotherapy (2 cycles of cisplatin OR carboplatin accord healthcare- investigator's choice - PLUS pemetrexed fresenius AND immunotherapy (2 cycles of Opdivo PLUS 1 cycle of Yervoy for inoperable T2-T3 TNM 9 patients with PM
• Процедура Extended pleurectomy/decortication in case of reaching operability
  After the systemic treatment the surgery will follow if patient is operable.

Первичные конечные точки

• To assess the percentage of successful completion of a neoadjuvant double chemotherapy / double immunotherapy regimen followed by surgery in a selected group of T2-T3 (according to TNM 9) patients with pleural mesothelioma. [Срок оценки: The primary end point will be measured on week 17 +/-2 weeks]

Вторичные конечные точки (4)

• Toxicity of the neoadjuvant double chemotherapy / double immunotherapy regimen and surgery. [Срок оценки: The End of Treatment will be at 17 weeks]
• Toxicity of the neoadjuvant double chemotherapy / double immunotherapy regimen and surgery. [Срок оценки: The End of Treatment will be at 17 weeks]
• Efficay of neoadjuvant double chemotherapy / double immunotherapy regimen in inoperable T2-3 PM patients. [Срок оценки: operability will be evaluated after systemic treatment on week 7-9.]
• Quality of life during the neoadjuvant double chemotherapy / double immunotherapy regimen and surgery. [Срок оценки: at week 17]

Критерии участия

Критерии включения

• Capable of written informed consent and adherence to study procedures
• Pathologically confirmed PM (epithelioid), cT2-3 N0-1 M0 according to UICC TNM 9 and considered inoperable by the Multidisciplinary Tumor Board of UZA/UZG at the start of the trail. They only enter the second surgical stage when becoming operable after neoadjuvant therapy
• Aged 18 years or older
• World Health Organization (WHO) Performance Status 0-1
• Fit for systemic chemotherapy, immunotherapy and surgery according to good clinical practice
• No pregnancy allowed: women of childbearing potential have to take adequate contraception to avoid pregnancy; men need to take adequate contraception (usage of a condom) to avoid pregnancy in female partners

Критерии исключения

• Operable PM patients according to TNM 9 criteria (T1) or inoperable PM patients who will not have a chance to become operable after neoadjuvant treatment according to TNM 9 criteria (some T3, all T4, N2-3, M1)
• Contralateral mediastinal (N2) or distant metastatic disease (evaluated by PET and chest CT)
• Patients unfit for systemic chemotherapy, immunotherapy or intrathoracic surgery. Patients with an active autoimmune disease or who have had prior splenectomy, an active/acute infection requiring antibiotics, a chronic infection (e.g. HIV, hepatitis B or C) or have a serious cardiac disease are unfit for systemic therapy because their immune system is not properly functioning
• Hypersensitivity or contraindications to the active substance or to any of the excipients of the medications (platinum salts, pemetrexed, ipilimumab, nivolumab) used in this study
• Concurrent active malignancy other than basal cell carcinoma of the skin or in situ carcinoma of the cervix including brain metastases
• Prior treatment with chemotherapy, immunotherapy, surgery (except for diagnostic thoracoscopy) or thoracic RT (including prophylactic tract irradiation)
• Patients with significantly altered mental status or with psychological, familial, sociological or geographical conditions potential hampering compliance with the study as decided by the investigator

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

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Бельгия · 1 центр

• University Hospital Antwerp — Edegem

Идентификаторы

NCT: NCT07121374 · 2387 · 2023-504302-11-02

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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