IMCgp100-202 Phase II Study in Advanced Uveal Melanoma
Research type
Research Study
Full title
A Phase II Randomized, Open-label, Multi-centre Study of the Safety and Efficacy of IMCgp100 Compared with Investigator's Choice in HLA-A*0201 Positive Patients with Previously Untreated Advanced Uveal Melanoma
IRAS ID
220229
Contact name
Paul Nathan
Contact email
Sponsor organisation
Immunocore Limited
Eudract number
2015-003153-18
Duration of Study in the UK
3 years, 3 months, 10 days
Research summary
This research study is being conducted to find out whether IMCgp100, an experimental immunotherapy treatment for people with Advanced Uveal Melanoma, is safe and superiorly beneficial in terms of overall survival of patients who have uveal cancer compared to an Investigators choice of standard treatment. 327 patients will take part, 2/3 will receive IMCgp100 and 1/3 will receive their Investigator's choice of treatment. Recruitment is expected to take 16 months. Patients who take part will receive IMCgp100 treatment by an intravenous infusion on days 1, 8 and 15 of every 21 day treatment cycle. Patients who receive their Investigator's choice of treatment will receive their treatment once every 21 days. The study will look at what the body does to the drug as well as what the drug does to the body by taking and examining blood and urine samples and reviewing radiological scans. Tumour samples will also be examined from the start of the study and during the study should the patient agree to this optional aspect of the study to see how the drug is affecting the tumour tissue through treatment.
REC name
London - Chelsea Research Ethics Committee
REC reference
17/LO/0497
Date of REC Opinion
21 Apr 2017
REC opinion
Favourable Opinion