DENdritic Cell Immunotherapy for Mesothelioma

NCT03610360 | Completed Phase 2 DMC

• 2 other identifiers: MM04DENIM
• Study Type: interventional
• Target: 176
• Locations: 5 countries
• Sites: 6

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.

Conditions

Mesothelioma

Keywords

DENIM

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

Arm A

ACTIVE COMPARATOR

Arm A will receive the study drug MesoPher plus best supportive care

Drug: MesoPher

Arm B

NO INTERVENTION

Arm B will follow best supportive care as deemed appropriate by the investigator.

Interventions

MesoPher DRUG

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

Arm A

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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.

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Amphera BV: lead
• TMC Pharma: collaborator

Study Sites (6)

University Hospital Antwerp

Antwerp, Belgium

Location

Centre Hospitalier Régional Universitaire de Lille

Lille, France

Location

Universitá Politecnica delle Marche - Ospedali Riuniti di Ancona

Ancona, Italy

Location

Netherlands Cancer Institue

Amsterdam, Netherlands

Location

Erasmus Medical Centre

Rotterdam, Netherlands

Location

University of Leicester

Leicester, United Kingdom

Location

Related Publications (1)

• Aerts JG, Belderbos R, Baas P, Scherpereel A, Bezemer K, Enninga I, Meijer R, Willemsen M, Berardi R, Fennell D, Kerstens R, Cornelissen R, van Meerbeeck JP; DENIM team. Dendritic cells loaded with allogeneic tumour cell lysate plus best supportive care versus best supportive care alone in patients with pleural mesothelioma as maintenance therapy after chemotherapy (DENIM): a multicentre, open-label, randomised, phase 2/3 study. Lancet Oncol. 2024 Jul;25(7):865-878. doi: 10.1016/S1470-2045(24)00191-8. Epub 2024 Jun 4.

  PMID: 38848742 DERIVED

MeSH Terms

Conditions

Mesothelioma

Condition Hierarchy (Ancestors)

Adenoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Mesothelial

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 24, 2018
• First Posted: August 1, 2018
• Study Start: June 21, 2018
• Primary Completion: June 30, 2022
• Study Completion: June 30, 2022
• Last Updated: February 1, 2024

Record last verified: 2024-01

Locations

NL (2); FR (1); IT (1); GB (1); BE (1)