rAd-IFN, Celecoxib and gemcitabine in MPM
Research type
Research Study
Full title
A Phase 3, Open-Label, Randomized, Parallel Group Study to Evaluate the Efficacy and Safety of Intrapleural Administration of Adenovirus-Delivered Interferon Alpha-2b (rAd-IFN) in Combination with Celecoxib and Gemcitabine in Patients with Malignant Pleural Mesothelioma
IRAS ID
248862
Contact name
Nicola Steele
Contact email
Sponsor organisation
Trizell, Ltd.
Eudract number
2017-003169-82
Duration of Study in the UK
5 years, 0 months, 0 days
Research summary
rAd-IFN is a gene therapy being developed and studied for the treatment of patients with Malignant Pleural Mesothelioma (MPM). MPM is a rare, aggressive cancer that develops in the thin layer of tissue surrounding the lungs known as the pleura, it is usually associated with asbestos, a carcinogen, causing an estimated 80% of cases.
This is a global phase III clinical trial, where approximately 300 patients are expected to be enrolled at 80 sites across Europe, North America, Australia and Russian Federation. The study is an open-label, randomised trial which consists of 3 period, a screening period, treatment period and long term follow-up. There will be 2 cohorts, a treatment group which will receive the study drug in combination with standard of care (SoC) and a control group which will receive standard of care (SoC) only.
The primary objective of this study is to compare the overall survival (OS) associated with rAd-IFN, when administered with Celecoxib and gemcitabine, versus that associated with Celecoxib and Gemcitabine alone for the treatment of patients with MPM who have failed a minimum of 1 treatment regimen and a maximum of 2 treatment regimens.
REC name
South Central - Oxford A Research Ethics Committee
REC reference
18/SC/0635
Date of REC Opinion
30 Jan 2019
REC opinion
Further Information Favourable Opinion