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EMERGE is a trial to investigate whether combining the histone deacetylase inhibitor (HDAC inhibitor) drug 4SC-202 with the immunotherapy drug avelumab is safe and improves outcomes for patients with previously treated gastroesophageal or colorectal cancer

ABSTRACT: Primary objectives: This trial is designed to evaluate the safety and efficacy of administering Domatinostat a histone deacetylate lysine-specific demethylase inhibitor plus avelumab, an anti-PD-L1 monoclonal antibody in patients with advanced bowel, stomach or oesophageal adenocarcinoma who have been previously treated with chemotherapy. This trial is in 2 stages: the first stage (Phase IIA, safety run-in) will establish a safe and tolerated dose of Domatinostat in combination with avelumab and the second stage (Phase IIB, efficacy) will assess the efficacy of this combination therapy in achieving radiological response according to RECIST 1.1 criteria. Primary Objective is to assess the efficacy of the addition of Domatinostat to avelumab therapy in patients with previously treated advanced OGA and CRC. Outcome measures: ORR according to RECIST 1.1 measured using CT imaging. Timepoint(s) of evaluation of this outcome measure is best response at 6 months.

DISEASE(S): Stomach Cancer,Colon Cancer,Oesophageal Adenocarcinoma,Advanced Gastrooesophageal And Colorectal Cancer

PROVIDER: 2536948 | ecrin-mdr-crc |

REPOSITORIES: ECRIN MDR

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