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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03610360
Other study ID # MM04
Secondary ID DENIM
Status Completed
Phase Phase 2/Phase 3
First received
Last updated
Start date June 21, 2018
Est. completion date June 30, 2022

Study information

Verified date January 2024
Source Amphera BV
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 176
Est. completion date June 30, 2022
Est. primary completion date June 30, 2022
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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.

Study Design


Related Conditions & MeSH terms


Intervention

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

Locations

Country Name City State
Belgium University Hospital Antwerp Antwerp
France Centre Hospitalier Régional Universitaire de Lille Lille
Italy Universitá Politecnica delle Marche - Ospedali Riuniti di Ancona Ancona
Netherlands Netherlands Cancer Institue Amsterdam
Netherlands Erasmus Medical Centre Rotterdam
United Kingdom University of Leicester Leicester

Sponsors (2)

Lead Sponsor Collaborator
Amphera BV TMC Pharma

Countries where clinical trial is conducted

Belgium,  France,  Italy,  Netherlands,  United Kingdom, 

Outcome

Type Measure Description Time frame Safety issue
Primary Overall survival rate 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. 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
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