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Protocol No. UW16092

Principal Investigator Deming, Dustin

Phase III

Age Group Adult

Scope National

Sponsor Type Industry

Title ARRAY-818-302 The BEACON CRC Study (Binimetinib, Encorafenib, And Cetuximab Combined to Treat BRAF-mutant ColoRectal Cancer):A Multicenter, Randomized, Open-label, 3-Arm Phase 3 Study of Encorafenib + Cetuximab Plus or Minus Binimetinib vs. Irinotecan/Cetuximab or Infusional 5-Fluorouracil (5-FU)/Folinic Acid (FA) /Irinotecan (FOLFIRI)/Cetuximab with a Safety Lead-in of Encorafenib + Binimetinib + Cetuximab in Patients with BRAF V600E-mutant Metastatic Colorectal Cancer

Objective The purpose of this study is to find out if the study medicines, binimetinib and encorafenib, are tolerated and have beneficial effects in people who have BRAF-mutant colorectal cancer. You may get either encorafenib + binimetinib + cetuximab (triplet) or encorafenib + cetuximab (doublet) or cetuximab + irinotecan or FOLFIRI (control).

Treatment Binimetinib and Encorafenib are medicines that has not been approved by the United States Food and Drug Administration (FDA). Cetuximab and Irinotecan are approved by the FDA for the treatment of colorectal cancer. The FOLFIRI regimen includes drugs (irinotecan, 5-fluorouracil, and folinic acid) which are approved by the FDA for the treatment of colorectal cancer.

Description You will be randomized in a 1:1:1 ratio by chance, like tossing a coin. You will be assigned to a study group: either the encorafenib + binimetinib + cetuximab group (Triplet Arm) or encorafenib + cetuximab (Doublet Arm) or the cetuximab + irinotecan or FOLFIRI group (Control Arm). Binimetinib is a medication that is taken by mouth twice a day, once in the morning and once in the evening, Encorafenib is a medication that is taken by mouth once a day, Cetuximab is a medication that is given through a needle into your vein (IV), over approximately a 1 to 2 hour period, Irinotecan is a medication that is given through a needle into your vein (IV) over approximately a 90-minute period, the FOLFIRI regime is given through a needle into your vein (IV) over approximately 120-minute period and the 5-fluorouracil will also be given through a pump over 2 days.

Key Eligibility
  • Histologically- or cytologically-confirmed colorectal cancer that is metastatic
  • Presence of BRAFV600E in tumor tissue as previously determined by a local assay or by the central laboratory
  • Progression of disease after 1 or 2 prior regimens in the metastatic setting
  • Evidence of measurable or evaluable non-measurable disease
  • Patients with known history of acute or chronic pancreatitis are ineligible
  • Patients with history of chronic inflammatory bowel disease or CrohnÂ’s disease requiring medical intervention ≤ 12 months prior to randomization are ineligible
  • Patients with known history of human immunodeficiency virus (HIV) infection, active hepatitis B or hepatitis C infection, are ineligible
  • Patients with known contraindication to receive 5-FU or FA, cetuximab or irinotecan at the planned doses are ineligible
  • Patients with more than 2 prior regimens in the metastatic setting are ineligible
  • Patients with a history of thromboembolic or cerebrovascular events ≤ 6 months prior to starting study are ineligible

Applicable Disease Sites Colon and Rectum

Therapies Involved Cytotoxic Chemotherapy

Drugs Involved 5-fluorouracil; 5-fu (5-fluorouracil); 5fu (5-fluorouracil); Binimetinib; Cetuximab; adrucil (5-fluorouracil); anti-EG Fr antibody c225 (Cetuximab); anti-epidermal growth factor receptor antibody c225 (Cetuximab); c225 (Cetuximab); camptosar (irinotecan); cpt-11 (irinotecan); efudex (5-fluorouracil); irinotecan; irinotecan hydrochloride (irinotecan)

Status Open

Participating Institutions UW Hospital and Clinics