EMERGE
Research type
Research Study
Full title
A multicenter phase II non-randomised trial assessing the efficacy of Domatinostat plus avelumab in patients with previously treated advanced mismatch repair proficient oesophagogastric and colorectal cancers
IRAS ID
228232
Contact name
David Cunningham
Contact email
Sponsor organisation
The Royal Marsden NHS Foundation Trust
Eudract number
2017-001770-42
Duration of Study in the UK
3 years, 0 months, 1 days
Research summary
EMERGE is a multicentre phase II open label nonrandomised trial of Domatinostat plus avelumab in patients with previously treated advanced inoperable or metastatic mismatch repair proficient gastroesophageal (GC) and colorectal cancer (CRC). This trial is designed to evaluate the safety and efficacy of administering Domatinostat, a histone deacetylate lysine-specific demethylase inhibitor plus avelumab, an anti-PD-L1 monoclonal antibody in these patient cohorts. This trial is in 2 stages: the first stage (Phase IIA, safety run-in) will establish a safe and tolerated dose of Domatinostat in combination with avelumab and the second stage (Phase IIB, efficacy) will assess the efficacy of this combination therapy in achieving radiological response according to RECIST 1.1 criteria.
REC name
London - City & East Research Ethics Committee
REC reference
18/LO/0320
Date of REC Opinion
24 Oct 2018
REC opinion
Further Information Favourable Opinion