Clinical trial NCT04082364: Combination Margetuximab, Retifanlimab, Tebotelimab, and Chemotherapy Phase 2/3 Trial in HER2+ Gastric/GEJ Cancer
Official title: A Phase 2/3 Trial to Evaluate Margetuximab in Combination With INCMGA00012 and Chemotherapy or MGD013 and Chemotherapy in Patients With Metastatic or Locally Advanced, Treatment-naïve, HER2-Positive Gastric or Gastroesophageal Junction Cancer
Conditions: Gastric Cancer
Gastroesophageal Junction Cancer
HER2-positive Gastric Cancer
Summary: This is a Phase 2/3, randomized, open-label study for the treatment of patients with HER2-positive Gastric cancer (GC) or Gastroesophageal Junction (GEJ) cancer conducted in two parts.
Part A is a single-arm cohort (Cohort A, 40 to 110 participants) will evaluate safety and efficacy of margetuximab plus retifanlimab.
Part B Part 1 has 4 arms (50 patients/arm). Participants will be randomized to margetuximab plus retifanlimab plus chemotherapy, margetuximab plus tebotelimab, plus chemotherapy, margetuximab plus chemotherapy, or trastuzumab plus chemotherapy.
Interventions:
description: margetuximab: Fc-modified anti-HER2 monoclonal antibody: 15 mg/kg IV, Day1 of each 3-week cycle
name: margetuximab
other_name: MGAH22
Margenza®
type: Biological
description: Retifanlimab: anti-PD-1 checkpoint inhibitor 375 mg IV, Day 1 of each 3-week cycle.
name: Retifanlimab
other_name: INCMGA00012
MGA012
type: Biological
description: Tebotelimab: anti PD-1, anti-LAG3 bispecific DART (R) molecule 600 mg IV, Day 1 of each 3-week cycle.
name: Tebotelimab
other_name: MGD013
type: Biological
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
name: Trastuzumab
other_name: Herceptin
type: Biological
description: Investigator choice of 1 of 2 chemotherapy regimens: XELOX or mFOLFOX6<br/>Chemotherapy<br/>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<br/>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.
name: Chemotherapy
type: Other
Study arms:
design_group_description: margetuximab plus retifanlimab
design_group_title: Chemotherapy-free arm
design_group_type: Experimental
design_group_description: margetuximab plus retifanlimab plus investigator choice of chemotherapy options.<br/>Chemotherapy options: capecitabine and oxaliplatin (XELOX) or modified 5-FU, leucovorin, and oxaliplatin regimen 6 (mFOLFOX-6)
design_group_title: Margetuximab, retifanlimab, and chemotherapy arm
design_group_type: Experimental
design_group_description: margetuximab plus tebotelimab plus investigator choice of chemotherapy options. Chemotherapy options: capecitabine and oxaliplatin (XELOX) or modified 5-FU, leucovorin, and oxaliplatin regimen 6 (mFOLFOX-6)
design_group_title: Margetuximab, tebotelimab and chemotherapy arm
design_group_type: Experimental
design_group_description: margetuximab plus investigator choice of chemotherapy options. Chemotherapy options: capecitabine and oxaliplatin (XELOX) or modified 5-FU, leucovorin, and oxaliplatin regimen 6 (mFOLFOX-6)
design_group_title: Margetuximab and chemotherapy arm
design_group_type: Experimental
design_group_description: Trastuzumab plus investigator choice of chemotherapy options. Chemotherapy options: capecitabine and oxaliplatin (XELOX) or modified 5-FU, leucovorin, and oxaliplatin regimen 6 (mFOLFOX-6)
design_group_title: Trastuzumab and chemotherapy arm
design_group_type: Active Comparator
Sponsor: MacroGenics, Inc.
Collaborators: Zai Lab (Shanghai) Co., Ltd.
Drug name mappings:
name: 特泊利单抗
lang: CN
name: Tebotelimab
lang: EN
name: 马吉妥昔单抗
lang: CN
name: Margetuximab
lang: EN
name: 瑞弗利单抗
lang: CN
name: Retifanlimab
lang: EN
name: レチファンリマブ（遺伝子組換え）
lang: JP