drugset

drugset / Trial / NCT03812796

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

NCT03812796 ↗

Phase 2 Unknown 75 enrolled Royal Marsden NHS Foundation Trust 4SC AG · collab Merck KGaA, Darmstadt, Germany · collab

NaSingle-groupOpen-labelTreatment

Summary

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

Timeline

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

Outcome

Mixed primary results

paper Responses in the OGA cohort met the criteria to expand to stage 2 of recruitment with an acceptable safety profile. PMID 38518549 ↗

paper There was insufficient signal in the CRC cohort to progress to stage 2. PMID 38518549 ↗

Publications

Cartwright E, Slater S, Saffery C, Tran A, Turkes F, Smith G, Aresu M, Kohoutova D, Terlizzo M, Zhitkov O, Rana I, Johnston EW, Sanna I, Smyth E, Mansoor W, Fribbens C, Rao S, Chau I, Starling N, Cunningham D. Phase II trial of domatinostat (4SC-202) in combination with avelumab in patients with previously treated advanced mismatch repair proficient oesophagogastric and colorectal adenocarcinoma: EMERGE. ESMO Open. 2024 Apr;9(4):102971. doi: 10.1016/j.esmoop.2024.102971. Epub 2024 Mar 21.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Avelumab	Monoclonal antibody	10 mg/kg	Intravenous
Subject	Domatinostat	Small molecule	200 mg	Oral

Indications