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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
Sponsor:
Collaborator:
TMC Pharma
Information provided by (Responsible Party):
Amphera BV

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
Mesothelioma Drug: MesoPher 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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 230 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Mesothelioma

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.



Primary Outcome Measures :
  1. 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.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

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


Contacts
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Contact: TMC Pharma +44 1252 842255 medical.dept@tmcpharma.com

Locations
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Belgium
University Hospital Antwerp Recruiting
Antwerp, Belgium
Principal Investigator: Jan Van Meerbeeck         
France
Centre Hospitalier Régional Universitaire de Lille Not yet recruiting
Lille, France
Principal Investigator: Arnaud Scherpereel         
Italy
Universitá Politecnica delle Marche - Ospedali Riuniti di Ancona Not yet recruiting
Ancona, Italy
Principal Investigator: Rossana Berardi         
Netherlands
Netherlands Cancer Institue Not yet recruiting
Amsterdam, Netherlands
Principal Investigator: Paul Baas         
Erasmus Medical Centre Recruiting
Rotterdam, Netherlands
Principal Investigator: Robin Cornelissen         
United Kingdom
University of Leicester Not yet recruiting
Leicester, United Kingdom
Principal Investigator: Dean Fennell         
Sponsors and Collaborators
Amphera BV
TMC Pharma

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Responsible Party: Amphera BV
ClinicalTrials.gov Identifier: NCT03610360     History of Changes
Other Study ID Numbers: MM04
DENIM ( Other Identifier: Amphera )
First Posted: August 1, 2018    Key Record Dates
Last Update Posted: August 1, 2018
Last Verified: July 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Amphera BV:
DENIM

Additional relevant MeSH terms:
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Mesothelioma
Adenoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Mesothelial