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Brief Title: Study of Magrolimab Given Together With FOLFIRI/BEV in Patients With Previously Treated Advanced Inoperable Metastatic Colorectal Cancer (mCRC)
Official Title: A Phase 2, Randomized, Open-Label Study Evaluating the Safety and Efficacy of Magrolimab in Combination With Bevacizumab and FOLFIRI Versus Bevacizumab and FOLFIRI in Previously Treated Advanced Inoperable Metastatic Colorectal Cancer (mCRC)
Study ID: NCT05330429
Brief Summary: The goals of this clinical study are to learn more about the safety, tolerability and effectiveness of magrolimab in combination with bevacizumab and 5-fluorouracil, irinotecan, and leucovorin (FOLFIRI) in previously treated participants with advanced inoperable metastatic colorectal cancer (mCRC). The primary objectives of this study are: (safety run-in cohort) to evaluate safety and tolerability, and the recommended Phase 2 dose (RP2D) and (randomized cohort) to evaluate the efficacy of magrolimab in combination with bevacizumab and 5-fluorouracil, irinotecan, and leucovorin (FOLFIRI) in previously treated participants with advanced inoperable metastatic colorectal cancer (mCRC).
Detailed Description:
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
City of Hope ( City of Hope National Medical Center, City of Hope Medical Center ), Duarte, California, United States
USC Norris Comprehensive Cancer Center, Los Angeles, California, United States
Stanford Cancer Center, Palo Alto, California, United States
Torrance Memorial Physician Network, Redondo Beach, California, United States
University of California Los Angeles (UCLA), Santa Monica, California, United States
Orlando Health Cancer Institute, Orlando, Florida, United States
Fort Wayne Medical Oncology and Hematology, Inc., Fort Wayne, Indiana, United States
University of Kansas, Westwood, Kansas, United States
University of Michigan, Ann Arbor, Michigan, United States
Roswell Park Cancer Institute, Buffalo, New York, United States
Hematology Oncology Associates of Central New York, PC, East Syracuse, New York, United States
AdventHealth, Rochester, New York, United States
Pennsylvania Hospital, Philadelphia, Pennsylvania, United States
Fox Chase Cancer Center, Philadelphia, Pennsylvania, United States
Avera Cancer Institute, Sioux Falls, South Dakota, United States
Sarah Cannon Research Institute, Nashville, Tennessee, United States
Texas Oncology, Dallas, Texas, United States
Baylor College of Medicine Medical Center, Houston, Texas, United States
Virginia Cancer Specialists, PC, Arlington, Virginia, United States
Seattle Cancer Care Alliance (SCCA), Seattle, Washington, United States
Westmead Hospital, Blacktown, New South Wales, Australia
Kinghorn Cancer Centre, Darlinghurst, New South Wales, Australia
Southside Cancer Care Centre, Miranda, New South Wales, Australia
Genesis Care North Shore, St Leonards, New South Wales, Australia
Princess Alexandra Hospital, Woolloongabba, Queensland, Australia
Flinders Medical Centre, Bedford Park, South Australia, Australia
Austin Health, Heidelberg, Victoria, Australia
The Alfred Hospital, Melbourne, Victoria, Australia
Hôpital de Jolimont, Haine-Saint-Paul, , Belgium
Centre Hospitalizer De L'Ardenne, Libramont-Chevigny, , Belgium
The Ottawa Hospital Cancer Centre, Ottawa, , Canada
Princess Margaret Cancer Centre, Toronto, , Canada
Centre Hospitalier Regional Universitaire Hopital Besancon, Besançon, , France
Centre Léon Bérard - Centre de Lutte contre le Cancer, Lyon, , France
Hopital franco brittanique, Paris, , France
CHU de Tours, Tours, , France
Carl Gustav Carus Management GMBH, Dresden, , Germany
Klinikum rechts der Isar der TU Munchen Zentrum fur klinische Studien der Klinik und Poliklinik fur Innere Medizin III, Munchen, , Germany
Hong Kong Integrated Oncology Centre, Hong Kong, , Hong Kong
Queen Mary Hospital, Hong Kong, , Hong Kong
Istituto Romagnolo per lo Studio dei Tumori "Dino Amadori" - Medical Oncology Department, Meldola, , Italy
Istituto Oncologico Veneto (IOV)- IRCCS, Padova, , Italy
Azienda Ospedaliera Universitaria Pisana- UO Oncologia Medica, Pisa, , Italy
Istituto di Ricovero e Cura a Carattere Scientifico - Istituto Clinico Humanitas, San Giovanni Rotondo, , Italy
San Bortolo General Hospital- Oncology Department, Vicenza, , Italy
Pan American Center for Oncology Trials, LLC, San Juan, , Puerto Rico
Hospital Universitari Vall d'Hebron, Barcelona, , Spain
Institut Català d'Oncologia- Hospital Duran I Reynals, L'Hospitalet de Llobregat, , Spain
Hospital General Universitario Gregorio Marañón, Madrid, , Spain
Hospital Universitario 12 de Octubre, Madrid, , Spain
Hospital HM Sanchinarro, Madrid, , Spain
Name: Gilead Study Director
Affiliation: Gilead Sciences
Role: STUDY_DIRECTOR