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IMMUNOPEC: Combination of neo-adjuvant Checkpoint Inhibition and Dendritic Cell Therapy (MesoPher) with Cytoreductive Surgery and Hyperthermic Intraperitoneal Chemotherapy in patients with Peritoneal Mesothelioma
EU CTIS ID: 2024-519626-21-00
What this study is testing
To assess the efficacy of (neo-)adjuvant CPI (nivolumab) and DCT (MesoPher) around CRS-HIPEC.
- Therapeutic exploratory (Phase II)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Histologically confirmed diagnosis of epithelioid peritoneal mesothelioma
- Patients must be at least 18 years old and must be able to give written informed consent.
- Fit to undergo CRS-HIPEC (as per standard of care of the treating physician/Institution)
- Ability to return to the study centre for adequate follow-up and vaccinations
- Written informed consent according to the ICH-GCP
- Men must be willing to use an effective contraceptive method during the study and for at least 12 months after the last study drug administration
You likely can't join if
- Extra-abdominal metastatic disease
- 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 (steroids) during chemotherapy is excluded from this 6-week interval. Inhaled or topical steroids, and adrenal replacement steroid ≤10 mg daily prednisone equivalent, are permit-ted in the absence of active autoimmune disease.
- Subject with any known active serious infection, including human immunodeficiency virus (HIV), hepatitis B or C virus, or syphilis infection.
- Medical or psychological impediment to probable compliance with the protocol
- Serious chronic or acute illness with an unwarranted high risk for the study treatment
- Pregnant or lactating women
See the full eligibility criteria
- Histologically confirmed diagnosis of epithelioid peritoneal mesothelioma
- Patients must be at least 18 years old and must be able to give written informed consent.
- Fit to undergo CRS-HIPEC (as per standard of care of the treating physician/Institution)
- Ability to return to the study centre for adequate follow-up and vaccinations
- Written informed consent according to the ICH-GCP
- Men must be willing to use an effective contraceptive method during the study and for at least 12 months after the last study drug administration
- 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 effective contraceptive method and for at least 12 months after the last study drug administration.
- Extra-abdominal metastatic disease
- 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 (steroids) during chemotherapy is excluded from this 6-week interval. Inhaled or topical steroids, and adrenal replacement steroid ≤10 mg daily prednisone equivalent, are permit-ted in the absence of active autoimmune disease.
- Subject with any known active serious infection, including human immunodeficiency virus (HIV), hepatitis B or C virus, or syphilis infection.
- Medical or psychological impediment to probable compliance with the protocol
- Serious chronic or acute illness with an unwarranted high risk for the study treatment
- Pregnant or lactating women
- An organic brain syndrome or other significant psychiatric abnormality which would comprise the study
- Patients with a known allergy to shellfish (may contain KLH).
The study team makes the final eligibility decision.
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, 18-64 years, 65+ years. The study team makes the final eligibility decision.
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BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.