DENIM: DENdritic Cell Immunotherapy for Mesothelioma
Study Details
Study Description
Brief Summary
This study is to evaluate the overall survival (OS) rate (determined from the time of randomization in the study) of subjects who receive dendritic cell immunotherapy with MesoPher plus best supportive care (BSC) compared to BSC alone.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
| Phase 2/Phase 3 |
Detailed Description
This is an open-label, randomized Phase II/III study in adult subjects with mesothelioma to evaluate the efficacy and anti-tumor activity of dendritic cell immunotherapy with MesoPher plus best supportive care compared to best supportive care alone. The safety, tolerability, quality of life and immunogenicity of MesoPher will also be evaluated.
The study includes a screening phase, a 7 month open-label treatment phase during which subjects visit the study center for administration of study drug and follow-up evaluations. An end-of-study (EoS) visit will be performed after completion of the study, after which data on survival, subsequent therapies and response to these therapies will be collected.
A target of 230 subjects satisfying all study criteria, will be randomized to receive either dendritic cell therapy plus best supportive care (Arm A) or best supportive care alone (Arm B).
Subjects in Arm A will undergo leukapheresis to obtain monocytes from which dendritic cells will be generated. These dendritic cells will be loaded in vitro with an allogeneic tumor cell lysate (PheraLys). Treatment with autologous dendritic cells loaded with PheraLys is called MesoPher. The treatment with Mesopher will start within 9 to 13 weeks after the last dose of chemotherapy. Subjects will receive 3 bi-weekly injections with MesoPher in addition to BSC. In case of stable disease or partial/complete response, an additional 2 injections will be given at weeks 18 and 30. Subjects will be administered with a maximum of 5 doses of MesoPher.
Subjects in Arm B will be treated with best supportive care according to the discretion of the local investigator.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Active Comparator: Arm A Arm A will receive the study drug MesoPher plus best supportive care |
Drug: MesoPher
Subjects in Arm A will undergo leukapheresis to obtain monocytes from which dendritic cells will be generated. These dendritic cells will be loaded in vitro with an allogeneic tumor cell lysate (PheraLys). Treatment with autologous dendritic cells loaded with PheraLys is called MesoPher
|
| No Intervention: Arm B Arm B will follow best supportive care as deemed appropriate by the investigator. |
Outcome Measures
Primary Outcome Measures
- Overall survival rate [from randomisation to study end (the last visit for the last subject participating in the study and the last data collection point completed) assessed in up to 102 weeks]
The primary outcome measure of this study is to evaluate the overall survival (OS) rate of subjects who receive dendritic cell immunotherapy with MesoPher plus best supportive care (BSC) compared to BSC alone. Overall survival rate will be determined from randomisation until death.
Eligibility Criteria
Criteria
Subjects will only be included with a histologically confirmed diagnosis of pleural malignant mesothelioma, who are non-progressive after 4 to 6 cycles with first line chemotherapy with antifolate/platinum.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | University Hospital Antwerp | Antwerp | Belgium | ||
| 2 | Centre Hospitalier Régional Universitaire de Lille | Lille | France | ||
| 3 | Universitá Politecnica delle Marche - Ospedali Riuniti di Ancona | Ancona | Italy | ||
| 4 | Netherlands Cancer Institue | Amsterdam | Netherlands | ||
| 5 | Erasmus Medical Centre | Rotterdam | Netherlands | ||
| 6 | University of Leicester | Leicester | United Kingdom |
Sponsors and Collaborators
- Amphera BV
- TMC Pharma
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- MM04
- DENIM