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A multicenter phase II study of Nivolumab monotherapy in recurrent and/or metastatic gastrointestinal cancer patients with high Tumor Mutation Burden (TMB-H)

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Trial Profile

A multicenter phase II study of Nivolumab monotherapy in recurrent and/or metastatic gastrointestinal cancer patients with high Tumor Mutation Burden (TMB-H)

Status: Active, no longer recruiting
Phase of Trial: Phase II

Latest Information Update: 28 Feb 2024

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At a glance

  • Drugs Nivolumab (Primary)
  • Indications Biliary cancer; Colorectal cancer; Gastric cancer; Gastro-enteropancreatic neuroendocrine tumour; Gastrointestinal cancer; Oesophageal cancer; Solid tumours
  • Focus Therapeutic Use
  • Acronyms bTMB-High Basket trial; GOZILA; TMB-H basket

Most Recent Events

  • 20 Jan 2024 Results of substudy from GOZILA , analyzing Clinical utility of upfront circulating tumor DNA (ctDNA) genotyping to guide first-line therapy in patients (pts) with metastatic colorectal cancer, presented at the 2024 Gastrointestinal Cancers Symposium
  • 20 Jan 2024 Results of exploratory analysis (n=41) assessing safety and efficacy of Nivolumab in patients (pts) with advanced gastrointestinal (GI) cancers with high plasma tumor mutational burden presented at the 2024 Gastrointestinal Cancers Symposium
  • 21 Jun 2022 Status changed from not yet recruiting to active, no longer recruiting.

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