NCT07121374

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

• Status: Recruiting
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 37 (estimated)
• Sponsor: University Hospital, Antwerp · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Conditions

• Pleural Epithelioid Mesothelioma
• Mesothelioma; Pleura
• Neoadjuvant Chemoimmunotherapy

Interventions

Type	Name	Description
DRUG	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
PROCEDURE	Extended pleurectomy/decortication in case of reaching operability	After the systemic treatment the surgery will follow if patient is operable.

Timeline

• Start date: 2025-07-22
• Primary completion: 2028-06-01
• Completion: 2029-07-01
• First posted: 2025-08-13
• Last updated: 2025-08-13

Locations

1 site across 1 country: Belgium