NEoadjuvant Chemotherapy and Immunotherapy for a selected group of inoperable pleural Mesothelioma patients (NECIM): a feasibility study

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Antwerp University Hospital

Participant type

Patients

Age range

18-64 years, 65+ years

Gender

Male and Female

Therapeutic area

Diseases [C] - Neoplasms [C04]

Trial duration

22 Jul 2025 → ongoing

Decision date (initial)

2025-03-11

Transition trial

No

Low-intervention

No

Rare-disease indication

Yes

Vulnerable population

No

Funding sources

Kom op tegen Kanker

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Therapy

Assess the percentage of successful completion of a new neoadjuvant double chemotherapy/double immunotherapy regimen and surgery in a selected group of T2-T3 (according to TNM 9) patients with pleural mesothelioma

Secondary objectives 3

1. Toxicity
2. Efficacy
3. Quality of life

Conditions and MedDRA coding

inoperable pleural mesothelioma

Regulatory references

Plan to share IPD

No

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 6

1. Capable of written informed consent and adherence to study procedures
2. Pathologically confirmed PM (histology: 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 trial. They only enter the second surgical stage when becoming operable after neoadjuvant therapy
3. Aged 18 years or older
4. World Health Organization (WHO) Performance Status 0-1
5. Fit for systemic chemotherapy, immunotherapy and surgery according to good clinical practice
6. No pregnancy allowed: women of childbearing potential have to take adequate contraception to avoid pregnancy; men need to take adequate contraception to avoid pregnancy in female partners

Exclusion criteria 7

1. 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)
2. Contralateral mediastinal (N2) or distant metastatic disease (evaluated by PET and chest CT)
3. 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
4. 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
5. Concurrent active malignancy other than basal cell carcinoma of the skin or in situ carcinoma of the cervix
6. Prior treatment with chemotherapy, immunotherapy, surgery (except for diagnostic thoracoscopy) or thoracic RT (including prophylactic tract irradiation)
7. 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

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. The rate of success, which is defined as a composite endpoint of feasibility (successful completion of 2 cycles of neoadjuvant immunotherapy and chemotherapy, being selected as operable thereafter and having extended P/D), efficacy (being alive and without signs of progressive disease) and safety (no grade 3-4 residual toxicity from systemic treatment and complete resolution of major complications (grade III - V) according to the Ottawa Classification at week 17+/-2weeks after start of treatment

Secondary endpoints 7

1. Toxicity, assessed by CTC-AE scores and by the Ottawa scores for surgery
2. Efficacy, assessed by the percentage of T2 and T3 PM patients becoming operable after double neoadjuvant chemotherapy and immunotherapy which is defined by the radiology department using the TNM 9 criteria
3. Pathological response as graded by light microscopy by an experienced pathologist estimating the percentage of viable tumor cells. Less than 10% viable cells will be considered a major pathological response (MPR). Zero % viable cells will be considered pathological complete response (pCR). RECIST protocol: response evaluation criteria in solid tumors.
4. Progression-free survival (PFS), measured from the date of registration until any progression
5. Overall survival (OS), measured from the date of registration until death or last available follow-up
6. Local disease-free survival (DFS), measured from the date of registration until local progression
7. Quality of life, assessed by the EQ-5D-5L score

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 5

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Antwerp University Hospital

Sponsor organisation

Antwerp University Hospital

Address

Drie Eikenstraat 655

City

Edegem

Postcode

2650

Country

Belgium

Scientific contact point

Organisation

Antwerp University Hospital

Contact name

prof. dr. Jeroen M.H. Hendriks

Public contact point

Organisation

Antwerp University Hospital

Contact name

Jody van der Beek

Locations

1 EU/EEA country · 2 investigational sites

By country

Investigational sites

Country notifications

Trial-start, recruitment-start, end and early-termination notifications submitted per Member State

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 16 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Application history

2 submissions — initial application plus substantial / non-substantial modifications