IMPALA trial
Research type
Research Study
Full title
IMPALA-Trial: Evaluation of an immunomodulatory maintenance treatment in patients with metastatic colorectal cancer with tumor reduction during induction treatment - A phase III trial
IRAS ID
154130
Contact name
David Cunningham
Contact email
david.cunningham@rmh.nhs.uk;jacqui.oates@rmh.nhs.uk
Sponsor organisation
MOLOGEN AG
Eudract number
2014-000834-50
Clinicaltrials.gov Identifier
Research summary
This is a randomised Phase III study. The purpose of this study is to assess if MGN1703 is effective at improving the survival of patients with metastatic colorectal cancer with tumor reduction after induction treatment with standard first line chemotherapy, with or without biological agents. A total of approximately 540 patients will participate in this study at multiple locations internationally.
The study is divided into different phases: screening, randomisation, maintenance treatment phase, re-induction treatment phase, end-of-treatment and surveillance. Participant will be assigned by chance to receive either MGN1703 or standard treatment for CRC.The standard treatment will form one of three strategies: continued induction treatment, maintenance of current treatment with a less intense regimen or a complete treatment break. This strategy will be decided by the study doctor.
A number of assessments will be performed during the study including physical examinations, tumour assessments, measurements of body weight, vital signs, blood tests, urine tests and electrocardiograms (ECG). An ECG is a standard test that doctors use to monitor electrical activity of the heart. These assessments are performed as part of the evaluation to determine if MGN1703 is effective and safe.
The study will run at approximately 4 centers in the UK and is sponsored by Mologen AG.
REC name
South Central - Oxford A Research Ethics Committee
REC reference
14/SC/0295
Date of REC Opinion
9 Jul 2014
REC opinion
Further Information Favourable Opinion