DENdritic Cell Immunotherapy for Mesothelioma (DENIM)
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|ClinicalTrials.gov Identifier: NCT03610360|
Recruitment Status : Recruiting
First Posted : August 1, 2018
Last Update Posted : August 1, 2018
|Condition or disease||Intervention/treatment||Phase|
|Mesothelioma||Drug: MesoPher||Phase 2 Phase 3|
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 Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||230 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official 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|
|Actual Study Start Date :||June 21, 2018|
|Estimated Primary Completion Date :||January 15, 2021|
|Estimated Study Completion Date :||January 15, 2021|
Active Comparator: Arm A
Arm A will receive the study drug MesoPher plus best supportive care
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.
- Overall survival rate [ Time Frame: 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03610360
|Contact: TMC Pharma||+44 1252 firstname.lastname@example.org|
|University Hospital Antwerp||Recruiting|
|Principal Investigator: Jan Van Meerbeeck|
|Centre Hospitalier Régional Universitaire de Lille||Not yet recruiting|
|Principal Investigator: Arnaud Scherpereel|
|Universitá Politecnica delle Marche - Ospedali Riuniti di Ancona||Not yet recruiting|
|Principal Investigator: Rossana Berardi|
|Netherlands Cancer Institue||Not yet recruiting|
|Principal Investigator: Paul Baas|
|Erasmus Medical Centre||Recruiting|
|Principal Investigator: Robin Cornelissen|
|University of Leicester||Not yet recruiting|
|Leicester, United Kingdom|
|Principal Investigator: Dean Fennell|