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New treatment option for Pleural Epithelioid Mesothelioma
Official title NEoadjuvant Chemotherapy and Immunotherapy for a Selected Group of Inoperable Pleural Mesothelioma Patients (NECIM): a Feasibility Study
ClinicalTrials.gov ID: NCT07121374
What this study is testing
What is Neoadjuvant chemo-immunotherapy?
Neoadjuvant chemo-immunotherapy is an investigational medicine, being studied as a potential treatment for pleural epithelioid mesothelioma.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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?
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- 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...
- 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
You likely can't join if
- Operable PM patients according to TNM 9 criteria (T1) or inoperable PM patients who will not have a chance to become operable after neoadjuvant...
- 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...
- Hypersensitivity or contraindications to the active substance or to any of the excipients of the medications (platinum salts, pemetrexed, ipilimumab...
- 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...
See the full eligibility 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...
- 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
- 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...
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Edegem, Antwerp, Belgium
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Edegem, Antwerp, Belgium. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.