2024-519626-21-00RecruitingPhase 2
IMMUNOPEC: Combination of neo-adjuvant Checkpoint Inhibition and Dendritic Cell Therapy (MesoPher) with Cytoreductive Surgery and Hyperthermic Intraperitoneal Chemotherapy in patients with Peritoneal Mesothelioma
Source: EU CTIS (euclinicaltrials.eu) · Last updated 16 Apr 2026
Brief summary (registry, in English)
To assess the efficacy of (neo-)adjuvant CPI (nivolumab) and DCT (MesoPher) around CRS-HIPEC.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 18 (estimated)
- First submitted
- 21 Nov 2024
- Start date
- 1 May 2026
- Lead sponsor
- Erasmus Universitair Medisch Centrum Rotterdam (Erasmus MC)
- Diseases
- Mesothelioma
- EU CT number
- 2024-519626-21-00
What you commit to
- Study type: Interventional · Phase 2
- Planned participants: 18
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of EU CTIS (euclinicaltrials.eu). It describes the study design.
AI-kivonat: who the study is looking for
Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for adults with epithelioid peritoneal mesothelioma who are fit for cytoreductive surgery with heated chemotherapy inside the abdomen (CRS-HIPEC). It tests nivolumab and a dendritic cell vaccine (MesoPher) around this surgery.
- Age
- 18 years or older.
- Sex
- Men and women can join.
- Disease stage
- Epithelioid peritoneal mesothelioma confirmed under the microscope. No disease outside the abdomen.
- Earlier treatment
- No more than 10 mg of prednisolone or equivalent per day, and no other immunosuppressive drugs, in the 6 weeks before the first study drug.
Main reasons for not taking part
- Cancer spread outside the abdomen
- Known active serious infection, including HIV, hepatitis B or C, or syphilis
- Pregnant or breastfeeding women
- Known allergy to shellfish
- Serious illness that makes the study treatment too risky
Read by machine on 9 Nov 2026.
Who cannot take part
Copied verbatim from EU CTIS (euclinicaltrials.eu) and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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.
Other illness
- 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).
Other
- Medical or psychological impediment to probable compliance with the protocol
- Pregnant or lactating women
Who the study is looking for
- 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.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Erasmus Universitair Medisch Centrum Rotterdam (Erasmus MC) | Rotterdam | Netherlands | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.