Study: NCT04082364

Intervention type: BIOLOGICAL
Group type: EXPERIMENTAL
Intervention: margetuximab
Description: margetuximab: Fc-modified anti-HER2 monoclonal antibody: 15 mg/kg IV, Day1 of each 3-week cycle

Intervention type: BIOLOGICAL
Group type: EXPERIMENTAL
Intervention: margetuximab
Description: margetuximab: Fc-modified anti-HER2 monoclonal antibody: 15 mg/kg IV, Day1 of each 3-week cycle

Intervention type: BIOLOGICAL
Group type: EXPERIMENTAL
Intervention: margetuximab
Description: margetuximab: Fc-modified anti-HER2 monoclonal antibody: 15 mg/kg IV, Day1 of each 3-week cycle

Intervention type: BIOLOGICAL
Group type: EXPERIMENTAL
Intervention: margetuximab
Description: margetuximab: Fc-modified anti-HER2 monoclonal antibody: 15 mg/kg IV, Day1 of each 3-week cycle

Intervention type: BIOLOGICAL
Group type: EXPERIMENTAL
Intervention: Retifanlimab
Description: Retifanlimab: anti-PD-1 checkpoint inhibitor 375 mg IV, Day 1 of each 3-week cycle.

Intervention type: BIOLOGICAL
Group type: EXPERIMENTAL
Intervention: Retifanlimab
Description: Retifanlimab: anti-PD-1 checkpoint inhibitor 375 mg IV, Day 1 of each 3-week cycle.

Intervention type: BIOLOGICAL
Group type: EXPERIMENTAL
Intervention: Tebotelimab
Description: Tebotelimab: anti PD-1, anti-LAG3 bispecific DART (R) molecule 600 mg IV, Day 1 of each 3-week cycle.

Intervention type: BIOLOGICAL
Group type: ACTIVE_COMPARATOR
Intervention: Trastuzumab
Description: Anti-HER2 monoclonal antibody 8 mg/kg loading dose and then 6 mg/kg administered IV on Day 1 of each 3-week cycle

Intervention type: OTHER
Group type: EXPERIMENTAL
Intervention: Chemotherapy
Description: Investigator choice of 1 of 2 chemotherapy regimens: XELOX or mFOLFOX6~Chemotherapy~XELOX chemotherapy Capecitabine: 1000 mg/m2 as oral capsules twice a day Days 1-14 of each cycle, Oxaliplatin: 130 mg/m2 of Day 1 of each 3-week cycle as IV infusion~mFOLFOX6 chemotherapy: Leucovorin: 400 mg/m2 every 2 weeks as IV infusion, 5-FU bolus: 400 mg/m2 every 2 weeks as IV infusion, 5-FU continuous infusion: 2400 mg/m2 every 2 weeks as a 46 hr infusion, Oxaliplatin: 85 mg/m2 every 2 weeks as IV infusion.

Intervention type: OTHER
Group type: EXPERIMENTAL
Intervention: Chemotherapy
Description: Investigator choice of 1 of 2 chemotherapy regimens: XELOX or mFOLFOX6~Chemotherapy~XELOX chemotherapy Capecitabine: 1000 mg/m2 as oral capsules twice a day Days 1-14 of each cycle, Oxaliplatin: 130 mg/m2 of Day 1 of each 3-week cycle as IV infusion~mFOLFOX6 chemotherapy: Leucovorin: 400 mg/m2 every 2 weeks as IV infusion, 5-FU bolus: 400 mg/m2 every 2 weeks as IV infusion, 5-FU continuous infusion: 2400 mg/m2 every 2 weeks as a 46 hr infusion, Oxaliplatin: 85 mg/m2 every 2 weeks as IV infusion.

Intervention type: OTHER
Group type: EXPERIMENTAL
Intervention: Chemotherapy
Description: Investigator choice of 1 of 2 chemotherapy regimens: XELOX or mFOLFOX6~Chemotherapy~XELOX chemotherapy Capecitabine: 1000 mg/m2 as oral capsules twice a day Days 1-14 of each cycle, Oxaliplatin: 130 mg/m2 of Day 1 of each 3-week cycle as IV infusion~mFOLFOX6 chemotherapy: Leucovorin: 400 mg/m2 every 2 weeks as IV infusion, 5-FU bolus: 400 mg/m2 every 2 weeks as IV infusion, 5-FU continuous infusion: 2400 mg/m2 every 2 weeks as a 46 hr infusion, Oxaliplatin: 85 mg/m2 every 2 weeks as IV infusion.

Intervention type: OTHER
Group type: ACTIVE_COMPARATOR
Intervention: Chemotherapy
Description: Investigator choice of 1 of 2 chemotherapy regimens: XELOX or mFOLFOX6~Chemotherapy~XELOX chemotherapy Capecitabine: 1000 mg/m2 as oral capsules twice a day Days 1-14 of each cycle, Oxaliplatin: 130 mg/m2 of Day 1 of each 3-week cycle as IV infusion~mFOLFOX6 chemotherapy: Leucovorin: 400 mg/m2 every 2 weeks as IV infusion, 5-FU bolus: 400 mg/m2 every 2 weeks as IV infusion, 5-FU continuous infusion: 2400 mg/m2 every 2 weeks as a 46 hr infusion, Oxaliplatin: 85 mg/m2 every 2 weeks as IV infusion.