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New treatment option for Mesotheliomas Pleural
Official title dENdritic Cell Therapy Combined With SURgEry in Mesothelioma
ClinicalTrials.gov ID: NCT05304208
What this study is testing
What is Mesopher?
Mesopher is an investigational medicine, given as an once-weekly injectable medicine, being studied as a potential treatment for mesotheliomas pleural.
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 ENSURE trial is an open label, single center, phase 1, feasibility study. Sixteen adult patients diagnosed with resectable epithelioid malignant pleural mesothelioma (MPM) will be enrolled following first-line chemotherapy.
- Phase 1: an early, usually small safety study
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
- Patients with a histologically confirmed diagnosis of epithelioid MPM who are eligible for 2 to 4 cycles of platinum-based chemotherapy. Patients who...
You likely can't join if
- is present (e.g. local progression with only focal chest invasion).
- Patients must be at least 18 years old and must be able to give written informed con-sent.
- Resectable disease defined by stage cT1-3, N0-1, M0 (I to IIIA) according to UICC TNM classification (8th edition). A fluorodeoxyglucose...
- Tumor tissue available after completing chemotherapy and before starting treatment with DCT. Tumor tissue can be obtained by either a CT-guided...
- Fit to receive platinum-based chemotherapy (as per standard of care of the treating physician/Institution) and undergo a P/D with optional removal of...
- Eastern Cooperative Oncology Group (ECOG) performance status 0-1 (Appendix 2).
See the full eligibility criteria
Who can join
- Patients with a histologically confirmed diagnosis of epithelioid MPM who are eligible for 2 to 4 cycles of platinum-based chemotherapy. Patients who progressed after chemotherapy will not be discontinued from the trial...
What rules you out
- is present (e.g. local progression with only focal chest invasion).
- Patients must be at least 18 years old and must be able to give written informed con-sent.
- Resectable disease defined by stage cT1-3, N0-1, M0 (I to IIIA) according to UICC TNM classification (8th edition). A fluorodeoxyglucose (FDG)-positron emission tomography (PET)-computerized tomography (CT) scan with...
- Tumor tissue available after completing chemotherapy and before starting treatment with DCT. Tumor tissue can be obtained by either a CT-guided needle biopsy or a Video-assisted thoracoscopic surgery (VATS) biopsy.
- Fit to receive platinum-based chemotherapy (as per standard of care of the treating physician/Institution) and undergo a P/D with optional removal of hemidiaphragm and pericardium. The responsible surgeon and chest...
- Eastern Cooperative Oncology Group (ECOG) performance status 0-1 (Appendix 2).
- Ability to return to the study center for adequate follow-up and vaccinations.
- Positive delayed-type hypersensitivity (DTH) skin test (induration \> 2mm after 48 hrs) against at least one positive control antigen tetanus toxoid.
- Written informed consent according to ICH-GCP.
- people must have adequate organ function and adequate bone marrow reserve at screening:
- creatinine ≤ 1.5 × upper limit of normal [ULN] or glomerular filtration rate ≥ 50 mL/min
- alanine aminotransferase (ALT), aspartate aminotransferase (AST), bilirubin ≤ 1.5 × ULN
- Absolute neutrophil count ≥1.5 x 109/L, platelet count ≥100 x 109/L, and Hb ≥9.0 g/dL. Criteria must be met without erythropoietin dependency and without packed red blood cell (pRBC) transfusion within last 2 weeks.
- Women of childbearing potential must have a negative serum pregnancy test at screening and a negative urine pregnancy test just prior to the first study drug administration on Day 1, and must be willing to use an...
- Men must be willing to use an effective contraceptive method (e.g. condom, vasectomy) during the study and for at least 12 months after the last study drug administration.
- Written informed consent according to the International Conference on Harmonisation (ICH)/Good Clinical Practice (GCP) guidelines. Exclusion Criteria:
- Clinical or radiological invasion of mediastinal structures (heart, aorta, spine, esophagus, etc.) and widespread chest wall invasion (stage T4). Involvement of N2 nodes. Stage IV (metastatic disease).
- Any different histology from the epithelioid MPM (as per assessed at time of diagnosis).
- Unavailability of tumor tissue after completing chemotherapy and before starting treatment with DCT.
- Subject with any concurrent medical, psychological or psychiatric disease or condition that is likely to compromise the ability to give informed consent or to interfere with study procedures or results, or that in the...
- Use of \>10 mg of prednisolone or equivalent/day (or other immunosuppressive agents) during the past 6 weeks before the first study drug administration and throughout the study. Prophylactic usage of dexamethasone...
- Major surgical procedure or significant traumatic injury within 28 days prior to randomization or anticipation of the need for major surgery (other than eP/D) during the course of study treatment.
- Subject with any previous malignancy except adequately treated basal cell or squamous cell skin cancer, superficial or in-situ cancer of the bladder or other cancer for which the subject has been disease-free for at...
- Prior treatment of any kind for mesothelioma, especially prophylactic track irradiation after diagnostic procedures.
- Clinically significant pleural effusion that cannot be managed with thoracentesis or pleurodesis (according to institutional practice). If pleurodesis is considered, it should be done before randomization.
- Subject with any known active serious infection, including human immunodeficiency virus (HIV), hepatitis B or C virus, or syphilis infection.
- Subject with a history of autoimmune disease, except for diabetes mellitus type I or other conditions, where patient can be eligible following discussion with medical monitor.
- Subject who has received an organ allograft.
- Serious intercurrent chronic or acute illness such as pulmonary (COPD or asthma) or cardiac (NYHA class III or IV) or hepatic disease or other illness considered by the study coordinator to constitute an unwarranted...
- Pregnant women, nursing mothers, lactating women, and women of child-bearing potential who are unwilling to use effective contraceptive methods (intrauterine de-vices, hormonal contraceptives, contraceptive pill...
- Men unwilling to use effective contraception for the duration of the study and for at least 12 months after the last study drug administration.
- Inadequate peripheral vein access to perform leukapheresis
- History of receiving any investigational treatment within 28 days of randomization.
- Absence of assurance of compliance with the protocol. Lack of availability for fol-low-up assessment.
- Patients with a known allergy to shellfish (may contain KLH).
The study team makes the final eligibility decision.
Where it's taking place
- Rotterdam, South Holland, Netherlands
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 Rotterdam, South Holland, Netherlands. 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.