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

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.

试验主要目标：本试验旨在评估组蛋白去乙酰化赖氨酸特异性去甲基化酶抑制剂多马司他（Domatinostat）联合抗PD-L1单克隆抗体阿维鲁单抗（avelumab），用于既往接受过化疗的晚期肠癌、胃癌或食管腺癌患者的安全性与有效性。本试验分为两个阶段：第一阶段（IIA期，安全性导入期）将确定多马司他联合阿维鲁单抗的安全耐受剂量；第二阶段（IIB期，有效性评价期）将依据实体瘤疗效评价标准1.1版（Response Evaluation Criteria in Solid Tumors 1.1, RECIST 1.1）评估该联合疗法的影像学应答有效性。本试验的主要目标为评估在既往接受过治疗的晚期食管胃腺癌（Oesophagogastric adenocarcinoma, OGA）与结直肠癌（Colorectal cancer, CRC）患者中，于阿维鲁单抗治疗基础上加用多马司他的疗效。结局指标：通过CT成像检测、依据RECIST 1.1标准判定的客观缓解率（Objective Response Rate, ORR）。该结局指标的评估时间点为6个月时的最佳应答。