LAST UPDATED
July 01, 2025
Clinicaltrials.gov ID
CTSID
OVERVIEW
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) (ELEVATE CRC)
PROTOCOL 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).
View moreParticipation requirements
Age
18 years +
Sex
All
Healthy Volunteers
No
Age
18 years +
Sex
All
Healthy Volunteers
No
Study details
Medical Condition
Metastatic Colorectal Cancer
Gender
N/A
Date
July 2022 - June 2024
Study Type
Interventional
Study Phase
Phase 2
Product
Magrolimab, Bevacizumab, Irinotecan, Fluorouracil, Leucovorin
Eligibility information
Inclusion criteria
- Previously treated individuals with inoperable metastatic colorectal cancer (mCRC) who are ineligible for checkpoint inhibitor therapy (microsatellite instability (MSI)-H or mismatch repair deficient (dMMR) and are excluded).
- 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
- Prior anticancer therapy including chemotherapy, hormonal therapy, or investigational agents within 3 weeks or within at least 4 half-lives prior to magrolimab dosing (up to a maximum of 4 weeks), whichever is shorter.
- 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.
- Note: Other protocol defined Inclusion/Exclusion criteria may apply.
Locations
Locations (51)
City of Hope ( City of Hope National Medical Center, City of Hope Medical Center )
Duarte, California, United States, 91010
USC Norris Comprehensive Cancer Center
Los Angeles, California, United States, 90033
Torrance Memorial Physician Network
Redondo Beach, California, United States, 90277
University of California Los Angeles (UCLA)
Santa Monica, California, United States, 90095
Orlando Health Cancer Institute
Orlando, Florida, United States, 32806
Fort Wayne Medical Oncology and Hematology, Inc.
Fort Wayne, Indiana, United States, 46845
Roswell Park Cancer Institute
Buffalo, New York, United States, 14263
Hematology Oncology Associates of Central New York, PC
East Syracuse, New York, United States, 13057
Pennsylvania Hospital
Philadelphia, Pennsylvania, United States, 19104
Fox Chase Cancer Center
Philadelphia, Pennsylvania, United States, 19111
Avera Cancer Institute
Sioux Falls, South Dakota, United States, 57105
Sarah Cannon Research Institute
Nashville, Tennessee, United States, 327203
Baylor College of Medicine Medical Center
Houston, Texas, United States, 77030
Virginia Cancer Specialists, PC
Arlington, Virginia, United States, 22205
Seattle Cancer Care Alliance (SCCA)
Seattle, Washington, United States, 98103
Kinghorn Cancer Centre
Darlinghurst, New South Wales, Australia, 2010
Southside Cancer Care Centre
Miranda, New South Wales, Australia, 2228
Genesis Care North Shore
St Leonards, New South Wales, Australia, 2065
Princess Alexandra Hospital
Woolloongabba, Queensland, Australia, 4102
Flinders Medical Centre
Bedford Park, South Australia, Australia, 5042
Centre Hospitalier Regional Universitaire Hopital Besancon
Besançon, France, 25030
Centre Léon Bérard - Centre de Lutte contre le Cancer
Lyon, France, 69008
Klinikum rechts der Isar der TU Munchen Zentrum fur klinische Studien der Klinik und Poliklinik fur Innere Medizin III
München, Germany, 81675
Istituto Romagnolo per lo Studio dei Tumori "Dino Amadori" - Medical Oncology Department
Meldola, Italy, 47014
Azienda Ospedaliera Universitaria Pisana- UO Oncologia Medica
Pisa, Italy, 56126
Istituto di Ricovero e Cura a Carattere Scientifico - Istituto Clinico Humanitas
San Giovanni Rotondo, Italy, 71013
San Bortolo General Hospital- Oncology Department
Vicenza, Italy, 36100
Pan American Center for Oncology Trials, LLC
San Juan, PR, Puerto Rico, 00902
Institut Català d'Oncologia- Hospital Duran I Reynals
L'Hospitalet de Llobregat, Spain, 8908
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