DENIM (DENdritic Cell Immunotherapy for Mesothelioma)
Research type
Research Study
Full title
A Randomized, Open-Label Phase II/III Study With Dendritic Cells Loaded With Allogeneic Tumour Cell Lysate (PheraLys) in Subjects With Mesothelioma as Maintenance Treatment (MesoPher) After Chemotherapy. DENIM (DENdritic Cell Immunotherapy for Mesothelioma)
IRAS ID
233867
Contact name
Dean Fennell
Contact email
Sponsor organisation
TMC Pharma Services
Eudract number
2017-001774-41
Clinicaltrials.gov Identifier
Duration of Study in the UK
3 years, 9 months, 1 days
Research summary
There is currently no recommended maintenance treatment for patients with pleural mesothelioma. A total of 230 eligible adult male or female subjects with pleural mesothelioma who give written consent to participate will be included in this open-label, randomised Phase II/III study. The study will compare a treatment consisting of the subject's own "activated" dendritic cells (a type of immunotherapy called MesoPher) with best supportive care (i.e. no active treatment but the current standard care). The study includes a screening phase, a 7-month open-label treatment phase and a 2 year follow-up phase.
The main objective is to see whether the active treatment prolongs their life but secondary objectives including progression free survival, adverse events and quality of life will also be assessed.REC name
Scotland B REC
REC reference
18/SS/0120
Date of REC Opinion
21 Dec 2018
REC opinion
Further Information Favourable Opinion