We are pleased to report that a new clinical trial for mesothelioma has started. The trial will evaluate the overall survival rate of mesothelioma patients who will receive a new form of immunotherapy treatment.
The trial is sponsored by Amphera BV – a company which develops dendritic cell immunotherapies for malignant mesothelioma and other cancers – in collaboration with TMC Pharma.
The purpose of the trial is to provide mesothelioma sufferers with dendritic cell immunotherapy, using a drug called MesoPher. This drug will be given to mesothelioma patients alongside the best supportive care.
The trial is described as an ‘open-label,’ randomised phase 2/3 study. It will investigate and assess the efficacy and anti-tumour activity of dendritic cell immunotherapy using MesoPher with supportive care (BSC) compared to just BSC alone.
The safety, tolerability and quality of life of patients will be reviewed and the immunogenicity of MesoPher will also be evaluated as part of the trial.
The new clinical trial includes a screening phase and then a 7 month open-label treatment phase. The patients who are participating in the trial will need to visit the study centres for administration of the study drug and follow-up evaluations. After the study has been finalised, end of study visits will then take place. This will give the researchers valuable data on survival rates, subsequent therapies and patient response to these therapies.
Recruitment of participants
Those leading the study hope to recruit 230 participants. In order to satisfy all of the study criteria, the treatment will be randomised, with some receiving the dendritic cell therapy plus BSC (known as Arm A of the trial) or BSC alone (Arm B).
The patients who receive treatment in Arm A will undergo leukapheresis to obtain monocytes. Dendritic cells will be generated from these monocytes. These dendritic cells will be loaded in vitro with what is known as ‘allogenic tumour cell lysate’ (PheraLys for short). Such treatment is known as MesoPher.
Those participating in the trial will have received courses of chemotherapy treatment before receiving Mesopher within 9 to 13 weeks after their last dose of the first line treatment.
Those who receive the potentially ground-breaking therapy will receive 3 bi-weekly injections with MesoPher, in addition to BSC. If, as a result of the treatment, the patient’s disease becomes stable or shrinks, then an additional 2 injections will be given during weeks 18 and 30 post-first line chemotherapy treatment. The maximum dose for MesoPher will be 5 injections in total.
The study started to recruit mesothelioma patients in June of 2018, and it is thought that the study’s completion date should be finalised by early 2021.
We hope that the DENIM trial will produce positive results for mesothelioma survival rates. We also hope it will show lower levels of toxicity compared to others such as radiotherapy and chemotherapy, therefore increasing response rates
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Van Meerbeeck, J. P., et al, “DENIM: 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 – BE”.