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Monoclonal Antibody
Epigenetic Modulation of the immunE Response in GastrointEstinal Cancers (EMERGE) (EMERGE Trial)
Phase 2
Waitlist Available
Led By David Cunningham
Research Sponsored by Royal Marsden NHS Foundation Trust
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up upto 2 years
Awards & highlights
No Placebo-Only Group
Summary
A multicenter phase II non-randomised trial assessing the efficacy of domatinostat (4SC-202) plus avelumab in patients with GI cancer
Eligible Conditions
- Gastrointestinal Cancer
- Cancer
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ upto 2 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~upto 2 years
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Main Phase IIB (efficacy) phase: Objective response rate using RECIST 1.1 criteria
Safety run-in phase: To establish a safe and tolerable dose of domatinostat in combination with avelumab for use in the main (Phase IIB efficacy) phase of the trial
Secondary study objectives
Disease control rate
Duration of objective response according to RECIST 1.1
Number of patients with adverse events (according to NCI-CTCAE version 4) as a measure of safety and tolerability
+2 moreAwards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
1Treatment groups
Experimental Treatment
Group I: Domatinostat plus AvelumabExperimental Treatment2 Interventions
This is a multicentre open-label, phase II non-randomised clinical trial domatinostat plus avelumab (two separate cohorts in phase IIB part of trial).
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Avelumab
FDA approved
Find a Location
Who is running the clinical trial?
Royal Marsden NHS Foundation TrustLead Sponsor
328 Previous Clinical Trials
10,151,755 Total Patients Enrolled
4SC AGIndustry Sponsor
14 Previous Clinical Trials
847 Total Patients Enrolled
Merck KGaA, Darmstadt, GermanyIndustry Sponsor
446 Previous Clinical Trials
114,827 Total Patients Enrolled
David CunninghamPrincipal InvestigatorConsultant Medical Oncologist
15 Previous Clinical Trials
2,363 Total Patients Enrolled