RecruitingPhase 1Phase 2NCT07121374

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


Sponsor

University Hospital, Antwerp

Enrollment

37 participants

Start Date

Jul 22, 2025

Study Type

INTERVENTIONAL

Conditions

Summary

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


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing whether chemotherapy combined with immunotherapy before surgery (neoadjuvant treatment) can make inoperable pleural mesothelioma (a rare cancer of the lining of the lungs) operable. Patients whose tumors shrink enough after treatment may then proceed to surgery. This is a selected, carefully evaluated group of patients with potentially resectable disease. **You may be eligible if...** - You are 18 or older with a confirmed diagnosis of epithelioid pleural mesothelioma (PM), stage cT2-3 N0-1 M0 - Your cancer was assessed as inoperable by a multidisciplinary tumor board at UZA or UZG at the start of the trial - Your general health allows you to receive chemotherapy, immunotherapy, and potentially surgery (WHO performance status 0–1) - You have provided written informed consent **You may NOT be eligible if...** - You have a non-epithelioid mesothelioma subtype (e.g., sarcomatoid) - Your cancer has spread beyond stage T3 or to distant sites (M1) - You are already considered operable before starting treatment - You have serious active infections, other cancers, or organ dysfunction Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGNeoadjuvant 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

PROCEDUREExtended pleurectomy/decortication in case of reaching operability

After the systemic treatment the surgery will follow if patient is operable.


Locations(1)

University Hospital Antwerp

Edegem, Antwerp, Belgium

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NCT07121374


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