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

NCT ID: NCT07121374

Last Updated: 2025-08-13

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 37 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-07-22
• Study Completion Date: 2029-07-31

Brief 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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Treatment

systemic treatment and surgery

Group Type: EXPERIMENTAL

Neoadjuvant chemo-immunotherapy

Intervention Type: DRUG

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

Extended pleurectomy/decortication in case of reaching operability

Intervention Type: PROCEDURE

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

Interventions

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

Intervention Type: DRUG

Extended pleurectomy/decortication in case of reaching operability

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

Intervention Type: PROCEDURE

Eligibility 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University Hospital, Ghent

OTHER

Sponsor Role: collaborator

Kom Op Tegen Kanker

OTHER

Sponsor Role: collaborator

University Hospital, Antwerp

OTHER

Sponsor Role: lead

Responsible Party

Jeroen Hendriks

PhD & MD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

University Hospital Antwerp

Edegem, Antwerp, Belgium

Site Status: RECRUITING

Countries

Belgium

Central Contacts

Prof. J. Hendriks, MD. PhD.

Role: CONTACT

jeroen.hendriks@uza.be

+3238214361

Facility Contacts

Hendriks Prof. J. Hendriks, MD. PhD.

Role: primary

jeroen.hendriks@uza.be

+3238214361

Other Identifiers

2023-504302-11-02

Identifier Type: CTIS

Identifier Source: secondary_id

2387

Identifier Type: -

Identifier Source: org_study_id