NCT02649829CompletedPhase 1/2
Autologous Dendritic Cell Vaccination in Mesothelioma
First-line Immunotherapy Using Wilms' Tumor Protein 1 (WT1)-Targeted Dendritic Cell Vaccinations for Malignant Pleural Mesothelioma
Source: ClinicalTrials.gov · Last updated 29 Apr 2025
Brief summary (registry, in English)
In this multicenter phase I/II trial, dendritic cells (DCs) loaded with the mesothelioma-associated tumor antigen WT1 will be used in conjunction with conventional chemotherapy for the frontline treatment of malignant pleural mesothelioma (MPM). The general objective is to provide the first-in-human experimental demonstration that the combination of platinum/pemetrexed-based chemotherapy with WT1-targeted DC vaccination is feasible and safe and enables the induction of both systemic and in situ mesothelioma-specific immune responses in patients with MPM.
- Status (registry)
- Completed
- Phase (registry)
- Phase 1/2
- Study type
- Interventional
- Enrollment
- 28 (actual)
- First submitted
- 7 Dec 2015
- Start date
- 3 Oct 2017
- Primary completion date
- 9 Mar 2025
- Lead sponsor
- University Hospital, Antwerp
- Diseases
- Mesothelioma, Kidney cancer, Lung cancer
- NCT number
- NCT02649829
- EU CT number
- 2024-517970-35-00
- EudraCT number
- 2014-001099-75
What you commit to
- Study type: Interventional · Phase 1/2
- Participants enrolled: 28
- From 3 Oct 2017 to the primary completion date, 9 Mar 2025
- 2 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Prior treatment for MPM
- Known concomitant presence of any immunosuppressive disease (e.g. HIV) or any active autoimmune condition, except for vitiligo
Other illness
- History of another malignancy within the last five years (except for carcinoma in situ of the cervix, basal cell or spinocellular carcinoma of the skin or unless the investigator rationalizes otherwise)
Other
- Unwilling or unable to comply with the study requirements
- Known proven metastases
- Pregnant or breast-feeding
Who the study is looking for
- Diagnosis with histologically proven epithelial
- Aged ≥ 18 years at the time of enrollment
- WHO performance status 0-1 at the time of enrollment
- Fit to undergo general anesthesia, a thoracoscopy, leukapheresis, chemotherapy, immunotherapy and P/D (in case of resectable disease)
- No history of receiving any investigational treatment within 28 days of study enrollment
- No history of intolerance to pemetrexed and/or cisplatin
- Women of child bearing potential must have negative serum or urine pregnancy test at the time of screening. They should use adequate birth control measures, as defined by the investigator, during the study treatment period and for at least hundred days after the last study treatment. If pregnancy does occur within this time period, the Principal investigator must be informed as soon as possible. Female subjects who are breastfeeding should discontinue nursing prior to the first dose of study treatment and until hundred days after the last study treatment
- Absence of any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule; those conditions should be discusses with the patient before registration in the trial. Absence of any other inability or unwillingness to comply with the requirements of the protocol as assessed by the investigator
- Before patient registration written informed consent must be given according to ICH/GCP, and national/local regulations
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (2)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Antwerp University Hospital Coordinator of this site? Confirm its status | Edegem | Belgium | Completed |
| Vitaz Coordinator of this site? Confirm its status | Sint-Niklaas | Belgium | Completed |
This page is information, not medical advice. Discuss any trial with your doctor.