Study of Magrolimab Given Together With FOLFIRI/Bevacizumab (BEV) in Participants With Previously Treated Advanced Inoperable Metastatic Colorectal Cancer (mCRC)
NCT ID: NCT05330429
Last Updated: 2025-07-01
Study Results
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View full resultsBasic Information
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TERMINATED
PHASE2
77 participants
INTERVENTIONAL
2022-07-08
2024-06-26
Brief Summary
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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).
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
SEQUENTIAL
TREATMENT
NONE
Study Groups
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Safety Run-in Cohort: Magrolimab + Bevacizumab + FOLFIRI
Participants will receive magrolimab + bevacizumab + FOLFIRI as mentioned below:
* Magrolimab 1 mg/kg on Cycle 1 Day 1; 30 mg/kg, every week (QW) beginning at Day 8 and for the next 6 doses (Cycle 1 Days 8, 15, and 22, and Cycle 2 Days 1, 8, 15, and 22); 30 mg/kg, every 2 weeks (Q2W) beginning 1 week after the last weekly 30 mg/kg dose (starting Cycle 3 Day 1 onwards) for every 28-day cycle.
* Bevacizumab: 5 mg/kg, Q2W (Days 1 and 15) of every 28-day cycle.
* FOLFIRI (Irinotecan 180 mg/m\^2 + leucovorin 400 mg/m\^2 + fluorouracil 400 mg/m\^2 IV bolus on first day, followed by 2400 mg/m\^2 over the next 46 hours, Q2W (Days 1 and 15) of every 28-day cycle.
Magrolimab
Administered intravenous infusion
Bevacizumab
Administered intravenous infusion
Irinotecan
Administered intravenous infusion
Fluorouracil
Administered intravenous infusion
Leucovorin
Administered intravenous infusion
Randomized Cohort: Magrolimab + Bevacizumab + FOLFIRI
Participants will receive magrolimab + bevacizumab + FOLFIRI as mentioned below:
* Magrolimab 1 mg/kg on Cycle 1 Day 1; 30 mg/kg, QW beginning at Day 8 and for the next 6 doses (Cycle 1 Days 8, 15, and 22, and Cycle 2 Days 1, 8, 15, and 22); 30 mg/kg, Q2W beginning 1 week after the last weekly 30 mg/kg dose (starting Cycle 3 Day 1 onwards) for every 28-day cycle.
* Bevacizumab: 5 mg/kg, Q2W (Days 1 and 15) of every 28-day cycle.
* FOLFIRI (Irinotecan 180 mg/m\^2 + leucovorin 400 mg/m\^2 + fluorouracil 400 mg/m\^2 IV bolus on first day, followed by 2400 mg/m\^2 over the next 46 hours, Q2W (Days 1 and 15) of every 28-day cycle.
Magrolimab
Administered intravenous infusion
Bevacizumab
Administered intravenous infusion
Irinotecan
Administered intravenous infusion
Fluorouracil
Administered intravenous infusion
Leucovorin
Administered intravenous infusion
Randomized Cohort: Bevacizumab + FOLFIRI
Participants will receive bevacizumab + FOLFIRI as mentioned below:
* Bevacizumab: 5 mg/kg, Q2W (Days 1 and 15) of every 28-day cycle.
* FOLFIRI (Irinotecan 180 mg/m\^2 + leucovorin 400 mg/m\^2 + fluorouracil 400 mg/m\^2 IV bolus on first day, followed by 2400 mg/m\^2 over the next 46 hours, Q2W (Days 1 and 15) of every 28-day cycle.
Bevacizumab
Administered intravenous infusion
Irinotecan
Administered intravenous infusion
Fluorouracil
Administered intravenous infusion
Leucovorin
Administered intravenous infusion
Interventions
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Magrolimab
Administered intravenous infusion
Bevacizumab
Administered intravenous infusion
Irinotecan
Administered intravenous infusion
Fluorouracil
Administered intravenous infusion
Leucovorin
Administered intravenous infusion
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Histologically or cytologically confirmed adenocarcinoma originating in the colon or rectum (excluding appendiceal and anal canal cancers) who have progressed on or after 1 prior systemic therapy in the setting where curative resection is not indicated. This therapy must have included chemotherapy based on 5-fluorouracil (5-FU) or capecitabine with oxaliplatin and either bevacizumab, or for individuals with rat sarcoma (RAS) wild-type and left-sided tumors, bevacizumab, cetuximab, or panitumumab.
* Measurable disease (Response Evaluation Criteria in Solid Tumors (RECIST) V1.1 criteria).
* Individuals must have an eastern cooperative oncology group (ECOG) performance status of 0 or 1.
* Life expectancy of at least 12 weeks.
* Laboratory measurements, blood counts: adequate hemoglobin, neutrophil, and platelet counts
* Adequate liver function.
* Adequate renal function.
Exclusion Criteria
* Known v-raf murine sarcoma viral oncogene homolog B1 gene mutation (BRAF V600E) or MSI-H mutations or dMMR.
* Persistent Grade 2 or more gastrointestinal bleeding.
* Individuals with prior irinotecan therapy.
* Clinically significant coronary artery disease or myocardial infarction within 6 months prior to inclusion.
* Peripheral neuropathy of more than Grade 2 (Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0).
* Known dihydropyrimidine dehydrogenase deficiency.
* Acute intestinal obstruction or sub-obstruction, history of inflammatory intestinal disease or extended resection of the small intestine. Presence of a colonic prosthesis.
* Unhealed wound, active gastric or duodenal ulcer, or bone fracture.
* History of abdominal fistulas, trachea-oesophageal fistulas, any other Grade 4 gastrointestinal perforations, nongastrointestinal fistulas, or intra-abdominal abscesses 6 months prior to screening.
* Uncontrolled arterial hypertension.
* Thromboembolic event in the 6 months before inclusion (eg, transitory ischemic stroke, stroke, subarachnoid hemorrhage) except peripheral deep vein thrombosis treated with anticoagulants.
* Active central nervous system (CNS) disease. Individuals with asymptomatic and stable, treated CNS lesions (radiation and/or surgery and/or other CNS-directed therapy who have not received corticosteroids for at least 4 weeks) are allowed.
* Red blood cell (RBC) transfusion dependence, defined as requiring more than 2 units of packed RBC transfusions during the 4-week period prior to screening.
* History of hemolytic anemia, autoimmune thrombocytopenia, or Evans syndrome in the last 3 months.
* Known hypersensitivity to any of the study drugs, the metabolites, or formulation excipient.
* Known inherited or acquired bleeding disorders.
* Significant disease or medical conditions, as assessed by the investigator and sponsor, that would substantially increase the risk-benefit ratio of participating in the study.
* Second malignancy, except treated basal cell or localized squamous skin carcinomas, or localized prostate cancer.
* Uncontrolled pleural effusion.
18 Years
ALL
No
Sponsors
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Gilead Sciences
INDUSTRY
Responsible Party
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Principal Investigators
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Gilead Study Director
Role: STUDY_DIRECTOR
Gilead Sciences
Locations
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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
München, , 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
Padua, , 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, PR, 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
Countries
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References
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Fakih MG, Tejani M, Ren X, Landes D, Werneke S, Curtis KK et al. 439TiP A phase II (ph2), randomized study of magrolimab with bevacizumab and FOLFIRI in previously treated patients with advanced inoperable metastatic colorectal cancer (mCRC). Annals of Oncology 2022; 33(7):S735.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Related Links
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Gilead Clinical Trials Website
Other Identifiers
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2022-500177-13
Identifier Type: OTHER
Identifier Source: secondary_id
GS-US-587-6156
Identifier Type: -
Identifier Source: org_study_id
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