DENdritic Cell Immunotherapy for Mesothelioma

Mesothelioma Clinical Trial

— DENIM  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03610360
• Other study ID #: MM04
• Secondary ID: DENIM
• Status: Completed
• Phase: Phase 2/Phase 3
• 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
• 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.

Related Conditions & MeSH terms

• Mesothelioma
• Mesothelioma, Malignant

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