Study Details

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).

Participation Requirements

Age

18 Years +

Sex

ALL

Healthy Volunteers

Medical Condition

Metastatic Colorectal Cancer

Gender

N/A

Date

July 2022 - June 2024

Study Type

INTERVENTIONAL

Study Phase

PHASE2

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-FU or capecitabine with oxaliplatin and either bevacizumab, or for patients with RAS wild-type and left-sided tumors, bevacizumab, cetuximab, or panitumumab.
Measurable disease (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 (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 (CTCAE Version 5.0).
Known dihydropyrimidine dehydrogenase deficiency.
Acute intestinal obstruction or subobstruction, 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

Stanford Cancer Center

Palo Alto, California, United States, 94305

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

University of Kansas

Westwood, Kansas, United States, 66205

University of Michigan

Ann Arbor, Michigan, United States, 48106

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

AdventHealth

Rochester, New York, United States, 14642

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

Texas Oncology

Dallas, Texas, United States, 75246

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

Westmead Hospital

Blacktown, New South Wales, Australia, 2148

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

Austin Health

Heidelberg, Victoria, Australia, 3084

The Alfred Hospital

Melbourne, Victoria, Australia, 3004

Hôpital de Jolimont

Haine-Saint-Paul, Belgium, 7100

Centre Hospitalizer De L'Ardenne

Libramont-Chevigny, Belgium, 6800

The Ottawa Hospital Cancer Centre

Ottawa, Canada, K1H 8L6

Princess Margaret Cancer Centre

Toronto, Canada, M5G 1X6

Centre Hospitalier Regional Universitaire Hopital Besancon

BesanÃ§on, France, 25030

Centre Léon Bérard - Centre de Lutte contre le Cancer

Lyon, France, 69008

Hopital franco brittanique

Paris, France, 75012

CHU de Tours

Tours, France, 37000

Carl Gustav Carus Management GMBH

Dresden, Germany, 01307

Klinikum rechts der Isar der TU Munchen Zentrum fur klinische Studien der Klinik und Poliklinik fur Innere Medizin III

Munchen, Germany, 81675

Hong Kong Integrated Oncology Centre

Hong Kong, Hong Kong, 0

Queen Mary Hospital

Hong Kong, Hong Kong

Istituto Romagnolo per lo Studio dei Tumori "Dino Amadori" - Medical Oncology Department

Meldola, Italy, 47014

Istituto Oncologico Veneto (IOV)- IRCCS

Padova, Italy, 35128

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, Puerto Rico, 00902

Hospital Universitari Vall d'Hebron

Barcelona, Spain, 8035

Institut Català d'Oncologia- Hospital Duran I Reynals

L'Hospitalet de Llobregat, Spain, 8908

Hospital General Universitario Gregorio Marañón

Madrid, Spain, 28007

Hospital Universitario 12 de Octubre

Madrid, Spain, 28041

Hospital HM Sanchinarro

Madrid, Spain, 28050

Study of Magrolimab Given Together With FOLFIRI/BEV in Patients With Previously Treated Advanced Inoperable Metastatic Colorectal Cancer (mCRC) (ELEVATE CRC)