Neoadjuvant chemo‑immunotherapy to make inoperable epithelioid pleural mesothelioma operable (NECIM)
NEoadjuvant Chemotherapy and Immunotherapy for a Selected Group of Inoperable Pleural Mesothelioma Patients (NECIM): a Feasibility Study
This trial tests whether two cycles of cisplatin or carboplatin with pemetrexed plus the immunotherapies nivolumab and ipilimumab can enable surgery for adults with previously inoperable epithelioid pleural mesothelioma.
Quick facts
| Phase | Phase1; Phase2 |
|---|---|
| Study type | Interventional |
| Enrollment | 37 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University Hospital, Antwerp Academic / other |
| Drugs / interventions | ipilimumab, nivolumab, chemotherapy, immunotherapy |
| Locations | 1 site (Edegem, Antwerp) |
| Trial ID | NCT07121374 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Adults (≥18) with pathologically confirmed epithelioid pleural mesothelioma staged cT2-3 N0-1 M0, WHO performance status 0–1, fit for systemic therapy and surgery, and judged initially inoperable but potentially convertible by the multidisciplinary tumor board are eligible.
Not a fit: Patients with non‑epithelioid histology, very advanced disease (T4, N2-3, M1), those judged unlikely to become operable after neoadjuvant treatment, or with poor performance status are unlikely to benefit from this approach.
Why it matters
Potential benefit: If successful, this approach could convert some patients from inoperable to operable status and improve survival and quality of life.
How similar studies have performed: Dual checkpoint blockade (nivolumab plus ipilimumab) has shown a survival benefit in unresectable pleural mesothelioma, but combining neoadjuvant chemotherapy with this dual immunotherapy specifically to convert inoperable cases to operable is relatively novel and not yet widely proven.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Edegem, Antwerp
- University Hospital Antwerp — Edegem, Antwerp, Belgium (Recruiting)
Study contacts
- Study coordinator: Prof. J. Hendriks, MD. PhD.
- Email: jeroen.hendriks@uza.be
- Phone: +3238214361
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.