Combination Margetuximab, Retifanlimab, Tebotelimab, and Chemotherapy Phase 2/3 Trial in HER2+ Gastric/GEJ Cancer
Completed · Phase 2/Phase 3
Conditions studied: Gastric Cancer, Gastroesophageal Junction Cancer, HER2-positive Gastric Cancer
In brief
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.
Key facts
- Study ID
- NCT04082364
- Run by
- MacroGenics
- People needed
- 82
- Starts
- 2019-09-30
- Expected to finish
- 2025-03-25
- Last updated by the study team
- 2025-06-08
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
Where it is running
- City of Hope Comprehensive Cancer Center - Duarte — Duarte, California, United States
- Norris Comprehensive Cancer Center (USC) — Los Angeles, California, United States
- Salinas Memorial — Salinas, California, United States
- UCLA School of Medicine — Santa Monica, California, United States
- Yale University — New Haven, Connecticut, United States
- Florida Cancer Specialists South — Fort Myers, Florida, United States
- Mayo Clinic - Jacksonville — Jacksonville, Florida, United States
- Ocala Oncology Center PL DBA Florida Cancer Affiliates - Ocala — Ocala, Florida, United States
- Florida Cancer Specialists North — St. Petersburg, Florida, United States
- Kaiser Permanente — Honolulu, Hawaii, United States
- University of Chicago — Chicago, Illinois, United States
- Edward H. Kaplan MD & Associates — Skokie, Illinois, United States
- Massachusetts General Hospital Cancer Center — Boston, Massachusetts, United States
- Henry Ford Health System — Detroit, Michigan, United States
- Cancer & Hematology Centers of Western Michigan - Lemmen-Holton Cancer Pavilion — Grand Rapids, Michigan, United States
- Mayo Clinic - Rochester — Rochester, Minnesota, United States
- Washington University School of Medicine — St Louis, Missouri, United States
- Nebraska Heme Onc — Lincoln, Nebraska, United States
- Rutgers Cancer Institute of New Jersey — New Brunswick, New Jersey, United States
- The University of New Mexico Comprehensive Cancer Center — Albuquerque, New Mexico, United States
- Stephenson Cancer Center at OUHSC — Oklahoma City, Oklahoma, United States
- Sarah Cannon Research Institute — Nashville, Tennessee, United States
- Oncology Consultants — Houston, Texas, United States
- Utah Cancer Specialists — Salt Lake City, Utah, United States
- Mayo Clinic - Scottsdale — Scottsdale, Arizona, United States
Full record on ClinicalTrials.gov
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