Actively Recruiting
Neoadjuvant Chemotherapy and Immunotherapy for Inoperable Pleural Mesothelioma Patients with Surgery Evaluation: A Feasibility Study
Led by University Hospital, Antwerp · Updated on 2025-08-13
37
Participants Needed
1
Research Sites
56 weeks
Total Duration
On this page
Sponsors
U
University Hospital, Antwerp
Lead Sponsor
U
University Hospital, Ghent
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating whether combining chemotherapy and immunotherapy can make surgery possible for adults with inoperable pleural mesothelioma, a type of cancer affecting the lung lining. The study aims to find out if two cycles of neoadjuvant chemotherapy and dual immunotherapy followed by surgery can be completed safely and effectively, and if this approach can help patients previously considered inoperable become eligible for surgery and improve survival outcomes. Participants will receive two cycles of chemotherapy using either cisplatin or carboplatin combined with pemetrexed, along with dual immunotherapy consisting of nivolumab and ipilimumab. After these treatments, a multidisciplinary team will evaluate if surgery is possible. If deemed operable, participants will undergo an extended pleurectomy/decortication surgery. This study includes a treatment phase followed by surgical intervention for those eligible. During the study, participants will be followed for one year to monitor side effects, quality of life, and survival. Researchers will assess the completion rate of the combined chemotherapy and immunotherapy regimen followed by surgery around week 17. Additional evaluations include treatment toxicity, surgery outcomes, operability after systemic treatment at weeks 7 to 9, and quality of life at week 17. Safety and effectiveness will be closely monitored throughout the study period.
CONDITIONS
Brief Title
NEoadjuvant Chemotherapy and Immunotherapy for a Selected Group of Inoperable Pleural Mesothelioma Patients (NECIM): a Feasibility Study
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Able to provide written informed consent and follow study procedures
- Diagnosed with epithelioid pleural mesothelioma, stage cT2-3 N0-1 M0, considered inoperable by the specialist team at the start
- Age 18 years or older
- World Health Organization performance status of 0 or 1
- Fit for chemotherapy, immunotherapy, and surgery
- Women of childbearing potential and men must use effective contraception to prevent pregnancy
You will not qualify if you...
- Patients with operable pleural mesothelioma (T1) or those unlikely to become operable after treatment (some T3, all T4, N2-3, M1)
- Presence of contralateral mediastinal (N2) or distant metastatic disease
- Unfit for chemotherapy, immunotherapy, or surgery due to active autoimmune disease, prior splenectomy, active infection needing antibiotics, chronic infection (e.g., HIV, hepatitis B or C), or serious heart disease
- Allergies or contraindications to study drugs (platinum salts, pemetrexed, ipilimumab, nivolumab)
- Having another active cancer besides certain skin or cervical cancers
- Previous chemotherapy, immunotherapy, surgery (except diagnostic thoracoscopy), or thoracic radiotherapy
- Significant mental, psychological, family, social, or geographic issues that could affect study participation
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - Approximately 7 to 9 weeks
Participants receive neoadjuvant chemotherapy (2 cycles of cisplatin or carboplatin plus pemetrexed) combined with immunotherapy (2 cycles of Opdivo plus 1 cycle of Yervoy).
Duration - Starts after treatment ends at week 7 to 9, duration varies
Participants who become operable after systemic treatment undergo extended pleurectomy/decortication surgery followed by immediate post-operative care.
Trial Site Locations
Total: 1 location
1
University Hospital Antwerp
Edegem, Antwerp, Belgium, 2650
Actively Recruiting
Research Team
P
Prof. J. Hendriks, MD. PhD.
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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