STAR-221: This study is comparing the effectiveness of different types of immunotherapy when they are given in addition to chemotherapy in people with previously untreated locally advanced or metastatic cancer of the stomach, gastro-oesophageal junction or oesophagusA 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

Summary

Eligible participants will be randomly allocated to either the Experimental Arm or the Active Comparator Arm. Both arms will involve treatment with immunotherapy and chemotherapy. In the Experimental Arm, participants will receive immunotherapy (domvanalimab and zimberelimab) plus chemotherapy (either FOLFOX or CAPOX). Participants in this arm will either receive domvanalimab and zimberelimab doses once every 4 weeks in addition to chemotherapy with FOLFOX once every 2 weeks, or domvanalimab and zimberelimab once every 3 weeks in addition to chemotherapy with CAPOX every 3 weeks. In the Active Comparator Arm, participants will receive immunotherapy (Nivolumab) plus chemotherapy (either FOLFOX or CAPOX). Participants in this arm will either receive Nivolumab every 2 weeks and FOLFOX every 2 weeks, or Nivolumab every 3 weeks and CAPOX every 3 weeks.