Spots Global Cancer Trial Database for Combination Margetuximab, Retifanlimab, Tebotelimab, and Chemotherapy Phase 2/3 Trial in HER2+ Gastric/GEJ Cancer
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Trial Identification
Brief Title: 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
Study ID: NCT04082364
Study Description
Brief 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 patients) will evaluate safety and efficacy of margetuximab plus retifanlimab. Part B Part 1 has 4 arms (50 patients/arm). Patients will be randomized to margetuximab plus retifanlimab plus chemotherapy, margetuximab plus tebotelimab, plus chemotherapy, margetuximab plus chemotherapy, or trastuzumab plus chemotherapy.
Detailed Description:
Keywords
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
Mayo Clinic - Scottsdale, Scottsdale, Arizona, United States
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, Saint 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, Saint 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
Virginia Cancer Specialists, Fairfax, Virginia, United States
Swedish Cancer Institute, Seattle, Washington, United States
University of Wisconsin, Madison, Wisconsin, United States
Beijing Cancer Hospital, Beijing, , China
Jilin Cancer Hospital (Second People's Hospital Of Jilin Province), Changchun, , China
Fujian Medical University - Fujian Provincial Cancer Hospital (Fujian Provincial Tumor Hospital), Fuzhou, , China
SIR RUN RUN SHAW Hospital, Zhejiang University school of medicine, Hangzhou, , China
Zhejiang Cancer Hospital, Hangzhou, , China
Affiliated Tumor Hospital of Harbin Medical University- the 3rd Affiliated Hospital of Harbin, Harbin, , China
The First Affiliated Hospital of Anhui Medical University, Hefei, , China
Anhui Provincial Cancer Hospital, Hefei, , China
Jinan Center Hospital, Jinan, , China
Nanjing University Medical School; Nanjing Drug Tower, Nanjing, , China
Zhongshan Hospital Fudan University, Shanghai, , China
Liaoning cancer hospital, Shenyang, , China
Hebei cancer hospital (The Fourth Affiliate), Shijiazhuang, , China
Wuhan Union Hospital, Wuhan, , China
Henan Cancer Hospital, Zhengzhou, , China
The First Affiliated Hospital of Zhengzhou University, Zhenzhou, , China
Institute of Clinical Cancer Research Krankenhaus Nordwest (IKF), Frankfurt, , Germany
Haematologisch-Onkologische Praxis Eppendorf, Hamburg, , Germany
Universitätsmedizin Mainz, Mainz, , Germany
Kliniken Maria Hilf GmbH, Monchengladbach, , Germany
Ospedale San Raffaele, Milan, , Italy
Istituto Europeo Di Oncologia, Milan, , Italy
Azienda Ospedaliero-Universitaria Pisana, Pisa, , Italy
Hallym University Sacred Heart Hospital, Anyang-Si, , Korea, Republic of
CHA bundang, Gyeonggi-do, , Korea, Republic of
Inje University Haeundae Paik Hospital, Haeundae, , Korea, Republic of
Seoul National University Bundang Hospital, Seongnam-si, , Korea, Republic of
Asan Medical Center, Seoul, , Korea, Republic of
Korea University Guro, Seoul, , Korea, Republic of
Korea University, Anam Hospital, Seoul, , Korea, Republic of
Samsung Medical Center, Seoul, , Korea, Republic of
Seoul National University Hospital, Seoul, , Korea, Republic of
Yonsei University College of Medicine (Severance Hospital), Seoul, , Korea, Republic of
Catholic University of Korea St. Vincent Hospital, Suwon, , Korea, Republic of
SPSK nr 1 in Lublin, Lublin, , Poland
Centrum Medyczne MrukMed, Rzeszów, , Poland
National University Hospital (Cancer Institute) -Singapore, Singapore, , Singapore
National Cancer Center Singapore, Singapore, , Singapore
Taipei Medical University Hospital, Taipei City, Taipei, Taiwan
Kaohsiung Chang Gung MemorialHospital, Kaohsiung, , Taiwan
Chang Gung Memorial Hospital, Keelung, Keelung, , Taiwan
Liuying Chi MeiMedical Hospital, Tainan city, , Taiwan
National Taiwan University, Taipei, , Taiwan
Cambridge University Hospitals NHS Foundation Trust Addenbrooke's Hospital, Cambridge, , United Kingdom
The Christie Hospital NHS Foundation Trust, Manchester, , United Kingdom
Contact Details
Name: Stephen L. Eck, MD, PhD
Affiliation: MacroGenics
Role: STUDY_DIRECTOR
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