Idera 2125-MEL-301
Research type
Research Study
Full title
A Randomized Phase 3 Comparison of IMO-2125 with Ipilimumab versus Ipilimumab Alone in Subjects with Anti-PD-1 Refractory Melanoma.
IRAS ID
241916
Contact name
Heather Shaw
Contact email
Sponsor organisation
Idera Pharmaceuticals, Inc.
Eudract number
2017-002454-36
ISRCTN Number
ISRCTN00000000
Clinicaltrials.gov Identifier
Clinicaltrials.gov Identifier
N/A, N/A
Duration of Study in the UK
3 years, 0 months, 0 days
Research summary
Research Summary
A Phase 3 clinical trial, which compares the effectiveness (how well it works) of the IMO-2125 (study drug)with and without ipilimumab (a drug currently approved for the treatment of advanced melanoma) in subjects with advanced melanoma.
Subjects will be randomly assigned by a 1 in 2 chance (like the flip of a coin) to receive either IMO-2125 + ipilimumab or ipilimumab alone. Subjects have an equal chance of being put into any one of the groups.
The main purpose of the study is to look at the overall survival (the time to death from any cause measured from the date of randomisation) and overall response rate (the number of patients with a tumour size reduction of a predefined amount for a minimum time period).Summary of Results
Study did not meet statistical significance with either co-primary endpoint. There were no safety issues identified.
REC name
South Central - Oxford C Research Ethics Committee
REC reference
19/SC/0113
Date of REC Opinion
28 Mar 2019
REC opinion
Further Information Favourable Opinion