NCT03812796

Epigenetic Modulation of the immunE Response in GastrointEstinal Cancers (EMERGE)

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 75 (estimated)
• Sponsor: Royal Marsden NHS Foundation Trust · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

A multicenter phase II non-randomised trial assessing the efficacy of domatinostat (4SC-202) plus avelumab in patients with GI cancer

Detailed description

During this phase II non randomised trial patients with microsatellite stable colorectal or gastroesophageal cancer which has previously been treated with chemotherapy will be treated with domatinostat plus avelumab.

Conditions

• Cancer
• GI Cancer

Interventions

Type	Name	Description
DRUG	Domatinostat	Domatinostat is an oral tablet which will be given at a variable dose during the Phase IIA safety run in phase of the trial. During the Phase IIB efficacy phase of the trial patients will be treated with domatinostat at the safe and tolerated combination dose identified during the Phase IIA safety run in phase.
DRUG	Avelumab	Avelumab is a monoclonal antibody which is given via an intravenous infusion at a dose of 10mg/kg every two weeks on the first day of a two week cycle. (Day 1 q 14d) from Cycle 2 onwards.

Timeline

• Start date: 2019-01-11
• Primary completion: 2021-11-30
• Completion: 2021-11-30
• First posted: 2019-01-23
• Last updated: 2019-02-05

Locations

2 sites across 1 country: United Kingdom