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

NCT07121374 · Status: RECRUITING · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 37

Last updated 2025-08-13

No results posted yet for this study

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

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.

Sponsors & Collaborators

  • University Hospital, Ghent

    collaborator OTHER

  • Kom Op Tegen Kanker

    collaborator OTHER

  • University Hospital, Antwerp

    lead OTHER

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-07-22
Primary Completion
2028-06-30
Completion
2029-07-31

Countries

  • Belgium

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07121374 on ClinicalTrials.gov