Overview
Sponsor-declared trial summary
Phase
Therapeutic exploratory (Phase II)
Status
Authorised, recruitment pending
Participants planned
18
Countries
1
Sites
1
Peritoneal Mesothelioma
To assess the efficacy of (neo-)adjuvant CPI (nivolumab) and DCT (MesoPher) around CRS-HIPEC.
Key facts
- Sponsor
- Erasmus Universitair Medisch Centrum Rotterdam (Erasmus MC)
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Digestive System Diseases [C06]
- Decision date (initial)
- 2025-04-09
- Transition trial
- No
- Low-intervention
- No
- Rare-disease indication
- Yes
- Vulnerable population
- No
Trial design
CTIS Part I — objectives, methods, condition coding
Main objective
Scope: Efficacy, Therapy, Safety
To assess the efficacy of (neo-)adjuvant CPI (nivolumab) and DCT (MesoPher) around CRS-HIPEC.
Secondary objectives 1
- To assess the safety, radiological response, immunological outcomes and survival outcomes.
Conditions and MedDRA coding
Peritoneal Mesothelioma
Eligibility criteria
Principal inclusion / exclusion criteria as submitted by sponsor
Inclusion criteria 7
- 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 criteria 8
- 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).
Endpoints
Primary and secondary outcome measures (English text)
Primary endpoints 1
- The progression free survival in patients that have received neo-adjuvant and adjuvant treatment with anti-PD-1 and vaccinations of DCT (5 administrations in total or less in case of production shortage) and cytoreduction.
Secondary endpoints 5
- Lymphocyte infiltration and activity will be measured by TCR repetoire analysis and immune phenotyping. Lymphocyte activity will be measured by apoptosis and proliferation markers using flow cytometry.
- Safety will be measured in AE’s and SAE’s
- Radiological response will be measured using CT scans following RECIST 1.1 criteria, resulting in: progressive or stable disease and partial or complete response.
- PCI will be evaluated during DLS and can be compared to the PCI seen at CRS-HIPEC
- Overall survival will be a secondary objective to evaluate.
Investigational products
Investigational medicinal products (IMPs), comparators, placebo, auxiliary
Test 2
Autologous Dendritic Cells Loaded with Allogenic Allogeneic Lysate of Mesothelioma Cell Lines
PRD11473259 · Product
- Active substance
- Autologous Dendritic Cells Loaded with Allogenic Allogeneic Lysate of Mesothelioma Cell Lines
- Substance synonyms
- MesoPher
- Pharmaceutical form
- PERSONALIZED CELLULAR PRODUCT
- Route of administration
- INTRAVENOUS INFUSION
- Max daily dose
- 50000000 U unit(s)
- Max total dose
- 350000000 U unit(s)
- Max treatment duration
- 12 Month(s)
- Authorisation status
- Not Authorised
- ATC code
- L03 — IMMUNOSTIMULANTS
- MA holder
- ERASMUS MC
- Paediatric formulation
- No
- Orphan designation
- Yes
- Orphan designation number
- EMA-OD-138-13
SCP8265340 · ATC
- Active substance
- Nivolumab
- Substance synonyms
- BMS936558, ABP 206
- Route of administration
- INTRAVENIOUS INFUSION
- Max daily dose
- 480 mg milligram(s)
- Max total dose
- 1440 mg milligram(s)
- Max treatment duration
- 8 Week(s)
- Authorisation status
- Authorised
- ATC code
- L01FF01 — NIVOLUMAB
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Erasmus Universitair Medisch Centrum Rotterdam (Erasmus MC)
- Sponsor organisation
- Erasmus Universitair Medisch Centrum Rotterdam (Erasmus MC)
- Address
- Dr. Molewaterplein 40
- City
- Rotterdam
- Postcode
- 3015 GD
- Country
- Netherlands
Scientific contact point
- Organisation
- Erasmus Universitair Medisch Centrum Rotterdam (Erasmus MC)
- Contact name
- Dr. E.V.E. Madsen
Public contact point
- Organisation
- Erasmus Universitair Medisch Centrum Rotterdam (Erasmus MC)
- Contact name
- Mitchell Emmers
Locations
1 EU/EEA country · 1 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Netherlands | Authorised, recruitment pending | 18 | 1 |
| Rest of world | — | 0 | — |
Investigational sites
Erasmus Universitair Medisch Centrum Rotterdam (Erasmus MC)
Surgical oncology, Wytemaweg 80, 3015 CN, Rotterdam
Results and documents
Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial
Documents 9 files
Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.
| Type | Title | Version |
|---|---|---|
| Protocol (for publication) | D1_Protocol 2024-519626-21-00 | 1 |
| Recruitment arrangements (for publication) | K1_Recruitment arrangements | 1 |
| Recruitment arrangements (for publication) | K1_Recruitment arrangements_TC | 1 |
| Recruitment arrangements (for publication) | K2_Recruitment material for online usage NL | 1 |
| Recruitment arrangements (for publication) | K2_Recruitment material for online usage NL_TC | 1 |
| Subject information and informed consent form (for publication) | L1_SIS en ICF IMMUNOPEC | 1 |
| Subject information and informed consent form (for publication) | L2_Nivolumab patientinformation NL | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC Nivolumab EN | 1 |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis NL 2024-519626-21-00 | 1 |
Application history
2 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2024-11-21 | Netherlands | Acceptable with conditions 2025-04-07
|
2025-04-09 |
| 2 | SUBSTANTIAL MODIFICATION | SM-1 | 2026-01-06 | Netherlands | Acceptable 2026-04-14
|
2026-04-16 |