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A Randomized, Open-Label, Multicenter Phase 3 Trial of Domvanalimab, Zimberelimab, and Chemotherapy Versus Nivolumab and Chemotherapy in Participants With Previously Untreated Locally Advanced Unresectable or Metastatic Gastric, Gastroesophageal Junction, and Esophageal Adenocarcinoma

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Trial Profile

A Randomized, Open-Label, Multicenter Phase 3 Trial of Domvanalimab, Zimberelimab, and Chemotherapy Versus Nivolumab and Chemotherapy in Participants With Previously Untreated Locally Advanced Unresectable or Metastatic Gastric, Gastroesophageal Junction, and Esophageal Adenocarcinoma

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

Latest Information Update: 03 Jul 2025

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At a glance

  • Drugs Domvanalimab (Primary) ; Zimberelimab (Primary) ; Capecitabine; Fluorouracil; Folinic acid; Nivolumab; Oxaliplatin
  • Indications Adenocarcinoma; Gastric cancer; Gastrointestinal cancer; Oesophageal cancer
  • Focus Registrational; Therapeutic Use
  • Acronyms STAR-221
  • Sponsors Arcus Biosciences; Taiho Pharmaceutical

Most Recent Events

  • 03 Jun 2025 Planned End Date changed from 1 May 2026 to 1 Feb 2027.
  • 03 Jun 2025 Planned primary completion date changed from 1 May 2026 to 1 Dec 2026.
  • 25 Feb 2025 According to an Arcus Biosciences media release, The first Phase 3 data readout for domvanalimab plus zimberelimab will be from the ongoing Phase 3 study STAR-221 is expected in 2026.

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