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DENdritic Cell Immunotherapy for Mesothelioma

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.

Tracking Information
First Received DateJuly 24, 2018
Last Changed DateJuly 31, 2018
Start DateJune 21, 2018
Anticipated Primary Completion DateJanuary 15, 2021
Primary Outcome Measures

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]

Descriptive Information
PhasePhase 2/Phase 3
Study TypeInterventional
Condition
  • Mesothelioma
Intervention
  • Drug: MesoPher
Study Arms / Comparison Groups2 / 0
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.

Recruitment Information
Recruitment StatusRecruiting
Anticipated Enrollment230
GenderAll
Ages18 Years - N/A
Accepts Healthy VolunteersNo
Contact TMC Pharma
Email: medical.dept@tmcpharma.com
Phone: +44 1252 842255
Eligibility 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.

Administrative Information
NCTIDNCT03610360
Responsible PartySponsor
SponsorAmphera BV
Verification DateJuly 2018
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