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

Status: Recruiting
Location: See location...
Intervention Type: Procedure, Drug
Study Type: Interventional
Study Phase: Phase 1/Phase 2
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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

Locations
Other Locations
Belgium
University Hospital Antwerp
RECRUITING
Edegem
Contact Information
Primary
Prof. J. Hendriks, MD. PhD.
jeroen.hendriks@uza.be
+3238214361
Time Frame
Start Date: 2025-07-22
Estimated Completion Date: 2029-07
Participants
Target number of participants: 37
Treatments
Experimental: Treatment
systemic treatment and surgery
Related Therapeutic Areas
Sponsors
Leads: University Hospital, Antwerp
Collaborators: Kom Op Tegen Kanker, University Hospital, Ghent

This content was sourced from clinicaltrials.gov