MedTrace Logo

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

NCT03812796 · Status: UNKNOWN · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 75

Last updated 2019-02-05

No results posted yet for this study

Summary

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

Conditions

Interventions

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.

Sponsors & Collaborators

  • 4SC AG

    collaborator INDUSTRY

  • Merck KGaA, Darmstadt, Germany

    collaborator INDUSTRY

  • Royal Marsden NHS Foundation Trust

    lead OTHER

Principal Investigators

  • David Cunningham · Consultant Medical Oncologist

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-01-11
Primary Completion
2021-11-30
Completion
2021-11-30

Countries

  • United Kingdom

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03812796 on ClinicalTrials.gov