Combination Margetuximab, INCMGA00012, MGD013, and Chemotherapy Phase 2/3 Trial in HER2+ Gastric/GEJ Cancer (MAHOGANY)

Studien-Informationen

Ein-/Ausschlusskriterien

Studien-Rationale

Studien-Arme

• Experimental: Margetuximab plus INCMGA00012
  margetuximab plus INCMGA00012
• Experimental: Margetuximab plus INCMGA00012 plus chemo
  margetuximab plus INCMGA00012 plus capecitabine and oxaliplatin (XELOX) or modified 5-FU, leucovorin, and oxaliplatin regimen 6 (mFOLFOX-6)
• Experimental: Margetuximab plus MGD013 plus chemo
  margetuximab plus MGD013 plus XELOX or mFOLFOX-6
• Experimental: Margetuximab plus chemo
  margetuximab plus XELOX or mFOLFOX-6
• Active Comparator: Control Arm
  Trastuzumab plus XELOX or mFOLFOX-6

Geprüfte Regime

• margetuximab plus INCMGA00012 (MGAH22 / MGA012 / ):
  margetuximab: Fc-modified anti-HER2 monoclonal antibody: • 15 mg/kg IV Day1 of each 3 week cycle INCMGA00012: anti-PD-1 checkpoint inhibitor: • 375 mg IV Day 1 of each 3 week cycle
• Margetuximab plus INCMGA00012 plus chemo (MGAH22 / MGA012 / ):
  margetuximab: Fc-modified anti-HER2 monoclonal antibody • 15 mg/kg IV Day1 of each 3 week cycle INCMGA00012: anti-PD-1 checkpoint inhibitor • 375 mg IV Day 1 of each 3 week cycle Chemotherapy Drug Capecitabine: 1000 mg/m2 as oral capsules twice a day Days 1-14 of each cycle, administered as part of XELOX chemotherapy Drug Oxaliplatin: 130 mg/m2 of Day 1 of each 3-week cycle as IV infusion, administered as part of XELOX chemotherapy Drug Leucovorin: 400 mg/m2 every 2 weeks as IV infusion, administered as part of mFOLFOX-6 chemotherapy Drug 5-FU bolus: 400 mg/m2 every 2 weeks as IV infusion, administered as part of mFOLFOX-6 chemotherapy Drug 5-FU continuous infusion: 2400 mg/m2 every 2 weeks as a 46 hr infusion, as part of mFOLFOX-6 Drug Oxaliplatin: 85 mg/m2 every 2 weeks as IV infusion, administered as part of mFOLFOX-6 chemotherapy
• Margetuximab plus MGD013 plus chemo (MGAH22):
  margetuximab: Fc-modified anti-HER2 monoclonal antibody • 15 mg/kg IV Day1 of each 3 week cycle MGD013: Anti-PD-1, anti-LAG-3 dual checkpoint inhibitor DART molecule • Dosing regimen located in the protocol Chemotherapy Drug Capecitabine: 1000 mg/m2 as oral capsules twice a day Days 1-14 of each cycle, administered as part of XELOX chemotherapy Drug Oxaliplatin: 130 mg/m2 of Day 1 of each 3-week cycle as IV infusion, administered as part of XELOX chemotherapy Drug Leucovorin: 400 mg/m2 every 2 weeks as IV infusion, administered as part of mFOLFOX-6 chemotherapy Drug 5-FU bolus: 400 mg/m2 every 2 weeks as IV infusion, administered as part of mFOLFOX-6 chemotherapy Drug 5-FU continuous infusion: 2400 mg/m2 every 2 weeks as a 46 hr infusion, as part of mFOLFOX-6 Drug Oxaliplatin: 85 mg/m2 every 2 weeks as IV infusion, administered as part of mFOLFOX-6 chemotherapy
• Margetuximab plus chemo (MGAH22):
  margetuximab: Fc-modified anti-HER2 monoclonal antibody • 15 mg/kg IV Day1 of each 3 week cycle Chemotherapy Drug Capecitabine: 1000 mg/m2 as oral capsules twice a day Days 1-14 of each cycle, administered as part of XELOX chemotherapy Drug Oxaliplatin: 130 mg/m2 of Day 1 of each 3-week cycle as IV infusion, administered as part of XELOX chemotherapy Drug Leucovorin: 400 mg/m2 every 2 weeks as IV infusion, administered as part of mFOLFOX-6 chemotherapy Drug 5-FU bolus: 400 mg/m2 every 2 weeks as IV infusion, administered as part of mFOLFOX-6 chemotherapy Drug 5-FU continuous infusion: 2400 mg/m2 every 2 weeks as a 46 hr infusion, as part of mFOLFOX-6 Drug Oxaliplatin: 85 mg/m2 every 2 weeks as IV infusion, administered as part of mFOLFOX-6 chemotherapy
• Trastuzumab plus chemo (Herceptin):
  Anti-HER2 monoclonal antibody • 8 mg/kg loading dose and then 6 mg/kg administered IV on Day 1 of each 3 week cycle Chemotherapy Drug Capecitabine: 1000 mg/m2 as oral capsules twice a day Days 1-14 of each cycle, administered as part of XELOX chemotherapy Drug Oxaliplatin: 130 mg/m2 of Day 1 of each 3-week cycle as IV infusion, administered as part of XELOX chemotherapy Drug Leucovorin: 400 mg/m2 every 2 weeks as IV infusion, administered as part of mFOLFOX-6 chemotherapy Drug 5-FU bolus: 400 mg/m2 every 2 weeks as IV infusion, administered as part of mFOLFOX-6 chemotherapy Drug 5-FU continuous infusion: 2400 mg/m2 every 2 weeks as a 46 hr infusion, as part of mFOLFOX-6 Drug Oxaliplatin: 85 mg/m2 every 2 weeks as IV infusion, administered as part of mFOLFOX-6 chemotherapy

Quelle: ClinicalTrials.gov