Neoadjuvant chemo‑immunotherapy to make inoperable epithelioid pleural mesothelioma operable (NECIM)

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

Adults with inoperable epithelioid pleural mesothelioma receive two cycles of platinum‑pemetrexed chemotherapy combined with dual checkpoint inhibition (nivolumab and ipilimumab) before re‑evaluation by a multidisciplinary team. If the tumor becomes resectable, participants undergo extended pleurectomy/decortication; otherwise they continue non‑surgical follow‑up. The study monitors safety, surgical conversion rate, one‑year survival, and quality of life outcomes. Procedures and outcomes are recorded at the University Hospital Antwerp with follow‑up visits for one year to capture adverse events and functional status.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* 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

Exclusion Criteria:

* 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

Where it's running

• University Hospital Antwerp
  Edegem, Antwerp, Belgium Recruiting

Study contacts

• Study coordinator: Prof. J. Hendriks, MD. PhD.
• Email: jeroen.hendriks@uza.be
• Phone: +3238214361

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.