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

Antwerp University Hospital (UZA)

Status and phase

Enrolling

Phase 2

Phase 1

Conditions

Pleural Epithelioid Mesothelioma

Neoadjuvant Chemoimmunotherapy

Mesothelioma; Pleura

Treatments

Procedure: Extended pleurectomy/decortication in case of reaching operability

Drug: Neoadjuvant chemo-immunotherapy

Study type

Interventional

Funder types

Other

Identifiers

NCT07121374

2023-504302-11-02 (EU Trial (CTIS) Number)

2387

Details and patient eligibility

About

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

Enrollment

37 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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