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

StatusActive, Not Recruiting
PhasePhase 2
Started

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Record History

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  1. Minor Final enrollment: 17 participants (planned 66) Show 5 more changesShow less
    • Primary completion date changed from estimate of Oct 1, 2026 to Aug 8, 2026
    • Study completion pushed from Oct 1, 2026 to Oct 15, 2027
    • Eligibility criteria expanded, about 19 words
    • Secondary endpoints: details revised at 5 of 5 entries
    • Site details revised at 16 of 207 sites
  2. Minor Study sites: 208 to 207v220
  3. Minor Study sites revised (208)v219
  4. Minor Study sites revised (208)v218
  5. Minor Study sites revised (208)v217
Show 9 earlier versionsHide 9 earlier versions
  1. Minor Study sites revised (208)v216
  2. Minor Re-verified, no change to tracked fieldsv215
  3. Minor Study sites revised (208)v214
  4. Minor Study sites: 209 to 208v213
  5. Minor 5 versions Re-verified since Apr 3, 2026, no change to tracked fieldsv208-v212
  1. Minor Primary and study completion pushed from May 1, 2026 to Oct 1, 2026v207
  2. Minor 35 versions Re-verified since Feb 11, 2026, no change to tracked fieldsv172-v206
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT05564403
Lead Sponsor National Cancer Institute (NCI)
Conditions
(from sponsor)
Advanced Biliary Tract Carcinoma, Advanced Gallbladder Carcinoma, Advanced Intrahepatic Cholangiocarcinoma, Recurrent Biliary Tract Carcinoma, Recurrent Gallbladder Carcinoma, Recurrent Intrahepatic Cholangiocarcinoma, Stage III Distal Bile Duct Cancer AJCC v8, Stage III Gallbladder Cancer AJCC v8 +9 more
Related terms Cholangiocarcinoma, Gallbladder Neoplasms, Klatskin Tumor
Enrollment 17 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov