Summary

Eligibility
for people ages 18 years and up (full criteria)
Location
at UCLA
Dates
study started
completion around

Description

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).

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)

Keywords

Metastatic Colorectal Cancer, Colorectal Neoplasms, Leucovorin, Bevacizumab, Magrolimab, Fluorouracil, Irinotecan

Eligibility

You can join if…

Open to people ages 18 years and up

  • 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.

You CAN'T join if...

  • 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

  • University of California Los Angeles (UCLA)
    Santa Monica California 90095 United States
  • USC Norris Comprehensive Cancer Center
    Los Angeles California 90033 United States
  • Torrance Memorial Physician Network
    Redondo Beach California 90277 United States
  • City of Hope ( City of Hope National Medical Center, City of Hope Medical Center )
    Duarte California 91010 United States
  • Stanford Cancer Center
    Palo Alto California 94305 United States

Details

Status
in progress, not accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Gilead Sciences
Links
Gilead Clinical Trials Website
ID
NCT05330429
Phase
Phase 2 research study
Study Type
Interventional
Participants
Expecting 135 study participants
Last Updated