IMMUNOPEC: Combination of neo-adjuvant Checkpoint Inhibition and Dendritic Cell Therapy (MesoPher) with Cytoreductive Surgery and Hyperthermic Intraperitoneal Chemotherapy in patients with Peritoneal Mesothelioma
Key facts
- Where
- Rotterdam, HollandiaSee the site
- Phase
- 2. fázis
Where in Hollandia
- Erasmus Universitair Medisch Centrum Rotterdam (Erasmus MC)Rotterdam, HollandiaTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Erasmus Universitair Medisch Centrum Rotterdam (Erasmus MC)
- Trial code
- EU 2024-519626-21-00
- Record updated
- 2026. április 16.
- Original description
To assess the efficacy of (neo-)adjuvant CPI (nivolumab) and DCT (MesoPher) around CRS-HIPEC.Read full original descriptionShow less
To assess the efficacy of (neo-)adjuvant CPI (nivolumab) and DCT (MesoPher) around CRS-HIPEC.
Inclusion: 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.
Exclusion: 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; Extra-abdominal metastatic disease; Subject with any known active serious infection, including human immunodeficiency virus (HIV), hepatitis B or C virus, or syphilis infection; Serious chronic or acute illness with an unwarranted high risk for the study treatment; An organic brain syndrome or other significant psychiatric abnormality which would comprise the study; Patients with a known allergy to shellfish (may contain KLH); Medical or psychological impediment to probable compliance with the protocol; Pregnant or lactating women.