🏛️ Verified NIH Record • Updated 2026-08-01

Study of Chemotherapy, With or Without Binimetinib in Advanced Biliary Tract Cancers in 2nd Line Setting (A ComboMATCH Treatment Trial) (NCT05564403)

FOLFOX in Combination With Binimetinib as 2nd Line Therapy for Patients With Advanced Biliary Tract Cancers With MAPK Pathway Alterations: A ComboMATCH Treatment Trial

🔵 Active, Not Recruiting Phase2 💊 Investigational Drug / Biologic Sponsor: National Cancer Institute (NCI)

🩺 Plain-English Summary (8th-Grade Level)

This phase II ComboMATCH treatment trial compares the usual treatment of modified leucovorin, fluorouracil and oxaliplatin (mFOLFOX6) chemotherapy to using binimetinib plus mFOLFOX6 chemotherapy to shrink tumors in patients with biliary tract cancers that have spread to other places in the body (advanced) and had progression of cancer after previous treatments (2nd line setting). Fluorouracil is in a class of medications called antimetabolites. It works by slowing or stopping the growth of cancer cells in the body. Oxaliplatin is in a class of medications called platinum-containing antineoplastic agents. It works by killing tumor cells. Leucovorin may help the other drugs in the mFOLFOX6 chemotherapy regimen work better by making tumor cells more sensitive to the drugs. Binimetinib is in a class of medications called kinase inhibitors. It works by blocking the action of the abnormal protein that signals tumor cells to multiply. This helps to stop or slow the spread of tumor cells. Giving binimetinib in combination with mFOLFOX6 chemotherapy may be effective in shrinking or stabilizing advanced biliary tract cancers in the 2nd line setting.

Who can join: Review the eligibility criteria below.

Location: University of Alabama at Birmingham Cancer Center — Birmingham, Alabama

Age range: 18 Years

📋 "Do I Qualify?" — 1-Minute Self Screener

Instant Checklist

Full eligibility criteria are available on the official NIH protocol. View the criteria ↗

📍 All Participating Trial Locations (207 Sites)

Showing the first 25 of 207 sites.

  • University of Alabama at Birmingham Cancer Center — Birmingham, Alabama
  • University of South Alabama Mitchell Cancer Institute — Mobile, Alabama
  • Mayo Clinic Hospital in Arizona — Phoenix, Arizona
  • NEA Baptist Memorial Hospital and Fowler Family Cancer Center - Jonesboro — Jonesboro, Arkansas
  • UC San Diego Moores Cancer Center — La Jolla, California
  • Cedars-Sinai Medical Center — Los Angeles, California
  • Presbyterian Intercommunity Hospital — Whittier, California
  • UM Sylvester Comprehensive Cancer Center at Aventura — Aventura, Florida
  • UM Sylvester Comprehensive Cancer Center at Coral Gables — Coral Gables, Florida
  • UM Sylvester Comprehensive Cancer Center at Deerfield Beach — Deerfield Beach, Florida
  • UF Health Cancer Institute - Gainesville — Gainesville, Florida
  • Mayo Clinic in Florida — Jacksonville, Florida
  • University of Miami Miller School of Medicine-Sylvester Cancer Center — Miami, Florida
  • UM Sylvester Comprehensive Cancer Center at Kendall — Miami, Florida
  • UM Sylvester Comprehensive Cancer Center at Plantation — Plantation, Florida
  • Hawaii Cancer Care Inc - Waterfront Plaza — Honolulu, Hawaii
  • Queen's Cancer Cenrer - POB I — Honolulu, Hawaii
  • Queen's Medical Center — Honolulu, Hawaii
  • Queen's Cancer Center - Kuakini — Honolulu, Hawaii
  • Hawaii Cancer Care - Westridge — ‘Aiea, Hawaii
  • The Queen's Medical Center - West Oahu — ‘Ewa Beach, Hawaii
  • Saint Alphonsus Cancer Care Center-Boise — Boise, Idaho
  • Saint Luke's Cancer Institute - Boise — Boise, Idaho
  • Saint Alphonsus Cancer Care Center-Caldwell — Caldwell, Idaho
  • Kootenai Health - Coeur d'Alene — Coeur d'Alene, Idaho

💰 Cost, Insurance & Patient Rights

  • 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
  • Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
  • Voluntary Participation: You may withdraw at any time without affecting your standard medical care.

💡 How to Participate

  1. Check the checklist above to see if you may qualify.
  2. Review the official NIH record below to find the coordinating site.
  3. Ask about the visit schedule, what is covered at no cost, and any travel support.
  4. Confirm with your own doctor before making a decision.
🏛️ View Official NIH Record ↗