Full TitleARRAY-818-302: 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
BRAF is a protein that, when mutated (altered), can stay activated and promote colorectal cancer growth. When BRAF is turned on, it activates another cancer-fueling protein called MEK. Encorafenib is an investigational drug that turns off BRAF, and binimetinib is an investigational drug that turns off MEK. Researchers hope that combining these two drugs will be effective for turning off the proteins that promote cancer growth.
In this study, researchers are evaluating the effectiveness of combining encorafenib, binimetinib, and cetuximab to treat patients with metastatic colorectal cancer containing a BRAF mutation called V600E. Cetuximab is already used to treat metastatic colorectal cancer and works by inhibiting another protein called EGFR. It is given intravenously (by vein), while encorafenib and binimetinib are taken orally (by mouth).
To be eligible for this study, patients must meet several criteria, including but not limited to the following:
- Patients must have metastatic colorectal cancer containing the V600E BRAF mutation.
- Prior treatment is permitted, but patients may not have already received inhibitors of RAF< MEK, or EGFR.
- Patients must be physically well enough that they are fully ambulatory, capable of all self care, and are capable of all but physically strenuous activities. As an example, patients must be well enough that they would be able to carry out office work or light housework.
- This study is for patients age 18 and older.
For more information and to inquire about eligibility for this study, please contact Dr. Rona Yaeger at 646-888-5109.