Spots Global Cancer Trial Database for A Study of Multiple Immunotherapy-Based Treatment Combinations in Patients With Locally Advanced Unresectable or Metastatic Gastric or Gastroesophageal Junction Cancer (G/GEJ) or Esophageal Cancer (Morpheus-Gastric and Esophageal Cancer)
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Trial Identification
Brief Title: A Study of Multiple Immunotherapy-Based Treatment Combinations in Patients With Locally Advanced Unresectable or Metastatic Gastric or Gastroesophageal Junction Cancer (G/GEJ) or Esophageal Cancer (Morpheus-Gastric and Esophageal Cancer)
Official Title: A Phase Ib/II, Open-Label, Multicenter, Randomized, Umbrella Study Evaluating the Efficacy and Safety of Multiple Immunotherapy-Based Treatment Combinations in Patients With Locally Advanced Unresectable or Metastatic Gastric or Gastroesophageal Junction Cancer or Esophageal Cancer (Morpheus-Gastric and Esophageal Cancer)
Study ID: NCT03281369
Study Description
Brief Summary: A Phase Ib/II, open label, multi-center, randomized study designed to assess the safety, tolerability, pharmacokinetics and preliminary anti-tumor activity of immunotherapy-based treatment combinations in patients with locally advanced unresectable or metastatic G/GEJ cancer (hereafter referred to as gastric cancer) and esophageal cancer. Two cohorts of patients with gastric cancer have been enrolled in parallel in this study: the second-line (2L) Gastric Cancer Cohort consists of patients with gastric cancer who have progressed after receiving a platinum-containing or fluoropyrimide-containing chemotherapy regimen in the first-line setting, and the first-line (1L) Gastric Cancer Cohort consists of patients with gastric cancer who have not received prior chemotherapy in this setting. In each cohort, eligible patients will be assigned to one of several treatment arms. Additionally, a cohort of patients with esophageal cancer who have not received prior systemic treatment for their disease will be enrolled in this study. Eligible patients will be randomized to chemotherapy or the combination of chemotherapy with checkpoint inhibitor immunotherapy.
Detailed Description:
Keywords
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
Mayo Clinic Cancer Center, Scottsdale, Arizona, United States
Uni of Southern California; Norris Comprehensive Cancer Ctr, Los Angeles, California, United States
UCLA Jonsson Comprehensive Cancer Center, Los Angeles, California, United States
Robert H. Lurie Comprehensive Cancer Center of Northwestern University, Chicago, Illinois, United States
University of Kentucky, Lexington, Kentucky, United States
Mayo Clinic - Rochester; Breast Cancer Center, Rochester, Minnesota, United States
Columbia University Medical Center, New York, New York, United States
Memorial Sloan Kettering Cancer Center, New York, New York, United States
Tennessee Oncology - Nashville, Nashville, Tennessee, United States
The University of Texas MD Anderson Cancer Center, Houston, Texas, United States
Froedtert and The Medical College of Wisconsin, Milwaukee, Wisconsin, United States
Blacktown Hospital, Blacktown, New South Wales, Australia
Monash Medical Centre-Moorabbin Campus, Clayton, Victoria, Australia
Peter MacCallum Cancer Centre; Medical Oncology, Melbourne, Victoria, Australia
Ben-Gurion University of the Negev - Soroka University Medical Center, Beer Sheva, , Israel
Rambam Health Care Campus; Oncology, Haifa, , Israel
Hadassah University Medical Center, Jerusalem, , Israel
Rabin MC; Davidof Center - Oncology Institute, Petach Tikva, , Israel
Sourasky Medical Centre, Tel-Aviv, , Israel
Yonsei University College of Medicine (YUCM)-Yonsei Cancer Center; Cancer Metastasis Research Center, Seodaemun-Gu, , Korea, Republic of
Seoul National University Bundang Hospital, Seongnam-si, , Korea, Republic of
Korea University Anam Hospital, Seoul, , Korea, Republic of
Seoul National University Hospital (SNUH) - Medical Oncology Center, Seoul, , Korea, Republic of
Samsung Medical Center, Seoul, , Korea, Republic of
University of Ulsan College of Medicine - Asan Medical Center (AMC) - Asan Cancer Center (ACC), Songpa-gu, , Korea, Republic of
The Catholic University of Korea St. Vincent's Hospital, Suwon-si, , Korea, Republic of
Universidad de Navarra - Clinica Universitaria de Navarra (CUN), Pamplona, Navarra, Spain
Hospital Universitari Vall dHebron; Oncology, Barcelona, , Spain
National Cheng Kung University Hospital, Tainan, , Taiwan
Taipei Veterans General Hospital, Taipei City, , Taiwan
National Taiwan University Hospital (NTUH) - Cancer Research Center, Zhongzheng Dist., , Taiwan
Beatson West of Scotland Cancer Centre, Glasgow, , United Kingdom
Barts and The London School of Medicine and Dentistry - Barts Cancer Institute (BCI)-CECM, London, , United Kingdom
The Royal Marsden, London, , United Kingdom
The Christie NHS Foundation Trust, Manchester, , United Kingdom
The Royal Marsden NHS Foundation Trust - Royal Marsden Hospital (RMH) - Sutton, Sutton, , United Kingdom
Contact Details
Name: Clinical Trials
Affiliation: Hoffmann-La Roche
Role: STUDY_DIRECTOR
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