NIVOLUMAB for Peritoneal mesothelioma

Inclusion criteria

• {"criterion_text":"- Histologically confirmed diagnosis of epithelioid peritoneal mesothelioma"}
• {"criterion_text":"- Patients must be at least 18 years old and must be able to give written informed consent."}
• {"criterion_text":"- Fit to undergo CRS-HIPEC (as per standard of care of the treating physician/Institution)"}
• {"criterion_text":"- Ability to return to the study centre for adequate follow-up and vaccinations"}
• {"criterion_text":"- Written informed consent according to the ICH-GCP"}
• {"criterion_text":"- 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"}
• {"criterion_text":"- 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

• {"criterion_text":"- Extra-abdominal metastatic disease"}
• {"criterion_text":"- 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."}
• {"criterion_text":"- Subject with any known active serious infection, including human immunodeficiency virus (HIV), hepatitis B or C virus, or syphilis infection."}
• {"criterion_text":"- Medical or psychological impediment to probable compliance with the protocol"}
• {"criterion_text":"- Serious chronic or acute illness with an unwarranted high risk for the study treatment"}
• {"criterion_text":"- Pregnant or lactating women"}
• {"criterion_text":"- An organic brain syndrome or other significant psychiatric abnormality which would comprise the study"}
• {"criterion_text":"- Patients with a known allergy to shellfish (may contain KLH)."}

Primary endpoints

• {"endpoint_text":"- 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.","definition_or_measurement_approach":""}

Secondary endpoints

• {"endpoint_text":"- 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.","definition_or_measurement_approach":"Measurement by TCR repertoire analysis, immune phenotyping, and flow cytometry assessment of apoptosis and proliferation markers."}
• {"endpoint_text":"- Safety will be measured in AE’s and SAE’s","definition_or_measurement_approach":"Safety assessed by recording adverse events (AEs) and serious adverse events (SAEs)."}
• {"endpoint_text":"- Radiological response will be measured using CT scans following RECIST 1.1 criteria, resulting in: progressive or stable disease and partial or complete response.","definition_or_measurement_approach":"Radiological response assessed by CT scans using RECIST 1.1 criteria."}
• {"endpoint_text":"- PCI will be evaluated during DLS and can be compared to the PCI seen at CRS-HIPEC","definition_or_measurement_approach":"Peritoneal Cancer Index (PCI) scores evaluated during diagnostic laparoscopy (DLS) and compared with PCI at CRS-HIPEC."}
• {"endpoint_text":"- Overall survival will be a secondary objective to evaluate.","definition_or_measurement_approach":""}

Methods

• K1_Recruitment arrangements (document available for publication) — Netherlands
• K2_Recruitment material for online usage NL (document available) — indicates online recruitment materials for Netherlands
• K2_Recruitment material for online usage NL_TC (document available)

Netherlands

Earliest CTIS Part Ii Submission Date

14-03-2025

Latest Decision Or Authorization Date

16-04-2026

Processing Time Days

398

Number Of Sites

1

Number Of Participants

18

Primary sponsor

Full Name

Erasmus Universitair Medisch Centrum Rotterdam (Erasmus MC)

Organisation Type

Hospital/Clinic/Other health care facility

Country Of Registered Address

Netherlands