DENdritic Cell Immunotherapy for Mesothelioma

Phase 2

Completed

• Conditions: Mesothelioma
• Interventions: Drug: MesoPher

• Registration Number: NCT03610360
• Lead Sponsor: 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.

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.

Study Timeline

• Study Start: 2018-06-21
• Study First Submitted: 2018-07-24
• Study First Submitted QC: 2018-07-31
• Study First Posted: 2018-08-01
• Primary Completion: 2022-06-30
• Study Completion: 2022-06-30
• Status Verified: 2024-01
• Last Update Submitted: 2024-01-31
• Last Update Posted: 2024-02-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 176

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
Overall survival rate	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.

Trial Locations

Locations (6)

University Hospital Antwerp; 🇧🇪 Antwerp, Belgium

Centre Hospitalier Régional Universitaire de Lille; 🇫🇷 Lille, France

Erasmus Medical Centre; 🇳🇱 Rotterdam, Netherlands

Universitá Politecnica delle Marche - Ospedali Riuniti di Ancona; 🇮🇹 Ancona, Italy

University of Leicester; 🇬🇧 Leicester, United Kingdom

Netherlands Cancer Institue; 🇳🇱 Amsterdam, Netherlands