Epigenetic Modulation of the immunE Response in GastrointEstinal Cancers (EMERGE)
- Registration Number
- NCT03812796
- Lead Sponsor
- Royal Marsden NHS Foundation Trust
- Brief 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.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 75
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Domatinostat plus Avelumab Domatinostat This is a multicentre open-label, phase II non-randomised clinical trial domatinostat plus avelumab (two separate cohorts in phase IIB part of trial). Domatinostat plus Avelumab Avelumab This is a multicentre open-label, phase II non-randomised clinical trial domatinostat plus avelumab (two separate cohorts in phase IIB part of trial).
- Primary Outcome Measures
Name Time Method 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 The DLT period is 28 days following the first treatment with domatinostat and avelumab Progression through dosing levels will be determined by the occurrence of dose limiting toxicities in the study population.
Main Phase IIB (efficacy) phase: Objective response rate using RECIST 1.1 criteria 6 months ORR defined as the proportion of patients with either CR or PR (assessed according to RECIST 1.1) by 6 months from combination treatment initiation. The best ORR will be presented as a proportion along side a 95% confidence interval
- Secondary Outcome Measures
Name Time Method Number of patients with adverse events (according to NCI-CTCAE version 4) as a measure of safety and tolerability Up to 90 days after last dose Safety of domatinostat and avelumab will be assessed by summarizing adverse events as a proportion
Progression free survival according to RECIST 1.1 upto 2 years PFS will be summarized using Kaplan Meier methods, presenting median survival with 95% confidence intervals. PFS is defined as the time from day of first treatment to disease progression or death from any cause. Patients without an event will be censored on day of last radiological follow up
Overall survival upto 2 years OS will be summarized using Kaplan Meier methods, presenting median survival with 95% confidence intervals. OS is defined as the time from say of first treatment to death from any cause. Alive patients will be censored at the last follow up date
Disease control rate At 6 and 12 months on treatment The proportion of patients with best disease control (CR, PR or SD) at 6 months and 12 months from initiation of combination treatment will be presented with a 95% confidence interval
Duration of objective response according to RECIST 1.1 upto 2 years DoOR will be summarized using Kaplan Meier methods. DoOR is defined as the time between the initial response to treatment and subsequent disease progression or relapse. Patients without an event will be censored on day of last radiological assessment
Trial Locations
- Locations (1)
The Royal Marsden Hospital NHS Foundation Trust
🇬🇧London, United Kingdom