MORAb009-201 Amatuximab in Unresectable Malignant Pleural Mesothelioma
Research type
Research Study
Full title
A Randomized, Double-blind, Placebo-controlled Study of the Safety and Efficacy of Amatuximab in Combination with Pemetrexed and Cisplatin in Subjects with Unresectable Malignant Pleural Mesothelioma
IRAS ID
183906
Contact name
Dean Fennell
Contact email
Sponsor organisation
Morphotek Inc
Eudract number
2014-004489-85
Duration of Study in the UK
6 years, 3 months, 4 days
Research summary
Malignant pleural mesothelioma (MPM) is a cancer that develops on the lining of the lungs.
This is a phase 2, multi-centre, double-blinded, randomised, parallel-group study taking place in subjects with unresectable MPM who have not received prior systemic therapy i.e. treatment which reaches cells via the bloodstream.
There are 2 treatment groups:- one group who will receive amatuximab 5mg/kg, administered weekly and another group who will receive placebo. Amatuximab and placebo are ‘Test Articles’, a term which refers to the experimental drug being tested. Both groups will receive their test article alongside standard combination chemotherapy (pemetrexed and cisplatin).
The aim of the study is to evaluate the safety and efficacy of amatuximab when used in conjunction with standard combination Chemotherapy. Subjects will be randomised on a 1:1 basis.
The study has 4 phases: Screening, Randomisation/Combination Treatment, Maintenance Treatment and Follow-up. Planned subject participation is 5 years (60 months), but will depend on circumstances, including progression of disease.
Following screening (30 days), eligible subjects will enter a 6 cycle combination treatment phase, each cycle lasting 21 days. Patients will receive the test article on Day 1 of each week and Chemotherapy on Day 1 of each 21-day Cycle. Patients who have received at least 4 cycles of treatment and who have not progressed in disease status will then enter a Maintenance phase where they will continue to receive test article weekly until disease progression. All subjects will be then followed up, (24 months), for survival and will be able to receive any medication deemed most appropriate by the treating Physician. Subjects who discontinue treatment for reasons other than disease progression will also be followed radiographically on same schedule as the maintenance treatment phase.
This is a multicentre, international study with the aim of achieving approximately 560 randomised subjects (280 in each treatment group).
REC name
East Midlands - Leicester Central Research Ethics Committee
REC reference
15/EM/0344
Date of REC Opinion
10 Sep 2015
REC opinion
Further Information Favourable Opinion