<HashMap><database>ecrin-mdr-crc</database><scores/><additional><omics_type>Clinical</omics_type><study_start_year>2018</study_start_year><condition>Colorectal cancer, Gastric cancer, Esophageal cancer, Biliary tract cancer, Pancreatic cancer, and Other gastrointestinal cancer</condition><disease>Colorectal Cancer, Gastric Cancer, Esophageal Cancer, Biliary Tract Cancer, Pancreatic Cancer, And Other Gastrointestinal Cancer</disease><study_type>Interventional</study_type><full_dataset_link>https://newmdr.ecrin.org/Study/2648298</full_dataset_link><location>Japan</location><study_start_month>9</study_start_month><repository>ECRIN MDR</repository><study_status>Active, not recruiting</study_status></additional><is_claimable>false</is_claimable><name>A multicenter phase II study of Nivolumab monotherapy in recurrent and/or metastatic gastrointestinal cancer patients with high Tumor Mutation Burden (TMB-H)</name><description>Interventions: Monotherapy with Nivolumab 360 mg, every 3 weeks intravenous administration
Primary outcome(s): Objective response rate (ORR) determined by RECIST v1.1
Study Design: Single arm Non-randomized</description><dates><creation>2018-09-15</creation></dates><accession>2648298</accession><cross_references><Japan Primary Registries Network>JPRN-UMIN000033182</Japan Primary Registries Network></cross_references></HashMap>