ClinicalTrials.gov record
Study of Chemotherapy, With or Without Binimetinib in Advanced Biliary Tract Cancers in 2nd Line Setting (A ComboMATCH Treatment Trial)
ClinicalTrials.gov ID: NCT05564403
Public ClinicalTrials.gov record NCT05564403. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
FOLFOX in Combination With Binimetinib as 2nd Line Therapy for Patients With Advanced Biliary Tract Cancers With MAPK Pathway Alterations: A ComboMATCH Treatment Trial
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT05564403
- Recruitment status
- Active, not recruiting
- Study type
- Interventional
- Phase
- Phase 2
- Enrollment
- 66 participants
Conditions and interventions
Conditions
- 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
- Stage III Hilar Cholangiocarcinoma AJCC v8
- Stage III Intrahepatic Cholangiocarcinoma AJCC v8
- Stage IV Distal Bile Duct Cancer AJCC v8
- Stage IV Gallbladder Cancer AJCC v8
- Stage IV Hilar Cholangiocarcinoma AJCC v8
- Stage IV Intrahepatic Cholangiocarcinoma AJCC v8
- Unresectable Biliary Tract Carcinoma
- Unresectable Gallbladder Carcinoma
- Unresectable Intrahepatic Cholangiocarcinoma
Interventions
- Binimetinib Drug
- Biopsy Procedure Procedure
- Biospecimen Collection Procedure
- Bone Scan Procedure
- Computed Tomography Procedure
- Echocardiography Test Procedure
- Fluorouracil Drug
- Leucovorin Calcium Drug
- Magnetic Resonance Imaging Procedure
- Multigated Acquisition Scan Procedure
- Oxaliplatin Drug
Drug · Procedure
Eligibility (public fields only)
- Age range
- 18 Years and older
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Feb 9, 2024 (Actual)
- Primary completion
- Oct 1, 2026 (Estimated)
- Completion
- Oct 1, 2026 (Estimated)
- Last update posted
- Aug 4, 2026
2024 – 2026
United States locations
- U.S. sites
- 207
- U.S. states
- 33
- U.S. cities
- 165
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| University of Alabama at Birmingham Cancer Center | Birmingham | Alabama | 35233 | — |
| University of South Alabama Mitchell Cancer Institute | Mobile | Alabama | 36688 | — |
| Mayo Clinic Hospital in Arizona | Phoenix | Arizona | 85054 | — |
| NEA Baptist Memorial Hospital and Fowler Family Cancer Center - Jonesboro | Jonesboro | Arkansas | 72401 | — |
| UC San Diego Moores Cancer Center | La Jolla | California | 92093 | — |
| Cedars-Sinai Medical Center | Los Angeles | California | 90048 | — |
| Presbyterian Intercommunity Hospital | Whittier | California | 90602 | — |
| UM Sylvester Comprehensive Cancer Center at Aventura | Aventura | Florida | 33180 | — |
| UM Sylvester Comprehensive Cancer Center at Coral Gables | Coral Gables | Florida | 33146 | — |
| UM Sylvester Comprehensive Cancer Center at Deerfield Beach | Deerfield Beach | Florida | 33442 | — |
| UF Health Cancer Institute - Gainesville | Gainesville | Florida | 32610 | — |
| Mayo Clinic in Florida | Jacksonville | Florida | 32224-9980 | — |
| University of Miami Miller School of Medicine-Sylvester Cancer Center | Miami | Florida | 33136 | — |
| UM Sylvester Comprehensive Cancer Center at Kendall | Miami | Florida | 33176 | — |
| UM Sylvester Comprehensive Cancer Center at Plantation | Plantation | Florida | 33324 | — |
| Hawaii Cancer Care Inc - Waterfront Plaza | Honolulu | Hawaii | 96813 | — |
| Queen's Cancer Cenrer - POB I | Honolulu | Hawaii | 96813 | — |
| Queen's Medical Center | Honolulu | Hawaii | 96813 | — |
| Queen's Cancer Center - Kuakini | Honolulu | Hawaii | 96817 | — |
| Hawaii Cancer Care - Westridge | ‘Aiea | Hawaii | 96701 | — |
| The Queen's Medical Center - West Oahu | ‘Ewa Beach | Hawaii | 96706 | — |
| Saint Alphonsus Cancer Care Center-Boise | Boise | Idaho | 83706 | — |
| Saint Luke's Cancer Institute - Boise | Boise | Idaho | 83712 | — |
| Saint Alphonsus Cancer Care Center-Caldwell | Caldwell | Idaho | 83605 | — |
| Kootenai Health - Coeur d'Alene | Coeur d'Alene | Idaho | 83814 | — |
| Saint Luke's Cancer Institute - Fruitland | Fruitland | Idaho | 83619 | — |
| Saint Luke's Cancer Institute - Meridian | Meridian | Idaho | 83642 | — |
| Saint Alphonsus Cancer Care Center-Nampa | Nampa | Idaho | 83687 | — |
| Saint Luke's Cancer Institute - Nampa | Nampa | Idaho | 83687 | — |
| Kootenai Clinic Cancer Services - Post Falls | Post Falls | Idaho | 83854 | — |
| Kootenai Clinic Cancer Services - Sandpoint | Sandpoint | Idaho | 83864 | — |
| Advocate Good Shepherd Hospital | Barrington | Illinois | 60010 | — |
| Northwestern University | Chicago | Illinois | 60611 | — |
| John H Stroger Jr Hospital of Cook County | Chicago | Illinois | 60612 | — |
| University of Chicago Comprehensive Cancer Center | Chicago | Illinois | 60637 | — |
| Advocate Illinois Masonic Medical Center | Chicago | Illinois | 60657 | — |
| AMG Crystal Lake - Oncology | Crystal Lake | Illinois | 60014 | — |
| Carle at The Riverfront | Danville | Illinois | 61832 | — |
| Cancer Care Specialists of Illinois - Decatur | Decatur | Illinois | 62526 | — |
| Decatur Memorial Hospital | Decatur | Illinois | 62526 | — |
| Northwestern Medicine Cancer Center Kishwaukee | DeKalb | Illinois | 60115 | — |
| Advocate Good Samaritan Hospital | Downers Grove | Illinois | 60515 | — |
| Carle Physician Group-Effingham | Effingham | Illinois | 62401 | — |
| Crossroads Cancer Center | Effingham | Illinois | 62401 | — |
| Advocate Sherman Hospital | Elgin | Illinois | 60123 | — |
| Northwestern Medicine Cancer Center Delnor | Geneva | Illinois | 60134 | — |
| Northwestern Medicine Glenview Outpatient Center | Glenview | Illinois | 60026 | — |
| Northwestern Medicine Grayslake Outpatient Center | Grayslake | Illinois | 60030 | — |
| Advocate South Suburban Hospital | Hazel Crest | Illinois | 60429 | — |
| Northwestern Medicine Lake Forest Hospital | Lake Forest | Illinois | 60045 | — |
| AMG Libertyville - Oncology | Libertyville | Illinois | 60048 | — |
| Condell Memorial Hospital | Libertyville | Illinois | 60048 | — |
| Carle Physician Group-Mattoon/Charleston | Mattoon | Illinois | 61938 | — |
| UC Comprehensive Cancer Center at Silver Cross | New Lenox | Illinois | 60451 | — |
| Cancer Care Center of O'Fallon | O'Fallon | Illinois | 62269 | — |
| Advocate Christ Medical Center | Oak Lawn | Illinois | 60453-2699 | — |
| Northwestern Medicine Orland Park | Orland Park | Illinois | 60462 | — |
| University of Chicago Medicine-Orland Park | Orland Park | Illinois | 60462 | — |
| Advocate Lutheran General Hospital | Park Ridge | Illinois | 60068 | — |
| Memorial Hospital East | Shiloh | Illinois | 62269 | — |
| Southern Illinois University School of Medicine | Springfield | Illinois | 62702 | — |
| Springfield Clinic | Springfield | Illinois | 62702 | — |
| Springfield Memorial Hospital | Springfield | Illinois | 62781 | — |
| Carle Cancer Center | Urbana | Illinois | 61801 | — |
| Northwestern Medicine Cancer Center Warrenville | Warrenville | Illinois | 60555 | — |
| UI Health Care Mission Cancer and Blood - Ankeny Clinic | Ankeny | Iowa | 50023 | — |
| UI Health Care Mission Cancer and Blood - Des Moines Clinic | Des Moines | Iowa | 50309 | — |
| UI Health Care Mission Cancer and Blood - Waukee Clinic | Waukee | Iowa | 50263 | — |
| University of Kentucky/Markey Cancer Center | Lexington | Kentucky | 40536 | — |
| Lafayette Family Cancer Center-EMMC | Brewer | Maine | 04412 | — |
| University of Maryland/Greenebaum Cancer Center | Baltimore | Maryland | 21201 | — |
| Walter Reed National Military Medical Center | Bethesda | Maryland | 20889-5600 | — |
| National Institutes of Health Clinical Center | Bethesda | Maryland | 20892 | — |
| UPMC Western Maryland | Cumberland | Maryland | 21502 | — |
| Trinity Health Saint Joseph Mercy Hospital Ann Arbor | Ann Arbor | Michigan | 48106 | — |
| University of Michigan Rogel Cancer Center | Ann Arbor | Michigan | 48109 | — |
| Trinity Health IHA Medical Group Hematology Oncology - Brighton | Brighton | Michigan | 48114 | — |
| Trinity Health Medical Center - Brighton | Brighton | Michigan | 48114 | — |
| University of Michigan - Brighton Center for Specialty Care | Brighton | Michigan | 48116 | — |
| Trinity Health IHA Medical Group Hematology Oncology - Canton | Canton | Michigan | 48188 | — |
| Trinity Health Medical Center - Canton | Canton | Michigan | 48188 | — |
| Chelsea Hospital | Chelsea | Michigan | 48118 | — |
| Trinity Health IHA Medical Group Hematology Oncology - Chelsea Hospital | Chelsea | Michigan | 48118 | — |
| Corewell Health Dearborn Hospital | Dearborn | Michigan | 48124 | — |
| Corewell Health Farmington Hills Hospital | Farmington Hills | Michigan | 48336 | — |
| Cancer Hematology Centers - Flint | Flint | Michigan | 48503 | — |
| Genesee Hematology Oncology PC | Flint | Michigan | 48503 | — |
| Genesys Hurley Cancer Institute | Flint | Michigan | 48503 | — |
| Hurley Medical Center | Flint | Michigan | 48503 | — |
| University of Michigan Health - Sparrow Lansing | Lansing | Michigan | 48912 | — |
| Trinity Health Saint Mary Mercy Livonia Hospital | Livonia | Michigan | 48154 | — |
| Henry Ford Saint John Hospital - Macomb Medical | Macomb | Michigan | 48044 | — |
| Trinity Health Saint Joseph Mercy Oakland Hospital | Pontiac | Michigan | 48341 | — |
| Corewell Health William Beaumont University Hospital | Royal Oak | Michigan | 48073 | — |
| Corewell Health Beaumont Troy Hospital | Troy | Michigan | 48085 | — |
| Huron Gastroenterology PC | Ypsilanti | Michigan | 48106 | — |
| Trinity Health IHA Medical Group Hematology Oncology Ann Arbor Campus | Ypsilanti | Michigan | 48197 | — |
| Sanford Joe Lueken Cancer Center | Bemidji | Minnesota | 56601 | — |
| Mercy Hospital | Coon Rapids | Minnesota | 55433 | — |
| Essentia Health - Deer River Clinic | Deer River | Minnesota | 56636 | — |
| Essentia Health Cancer Center | Duluth | Minnesota | 55805 | — |
| Fairview Southdale Hospital | Edina | Minnesota | 55435 | — |
| Essentia Health Hibbing Clinic | Hibbing | Minnesota | 55746 | — |
| Saint John's Hospital - Healtheast | Maplewood | Minnesota | 55109 | — |
| Abbott-Northwestern Hospital | Minneapolis | Minnesota | 55407 | — |
| Mayo Clinic in Rochester | Rochester | Minnesota | 55905 | — |
| Park Nicollet Clinic - Saint Louis Park | Saint Louis Park | Minnesota | 55416 | — |
| Regions Hospital | Saint Paul | Minnesota | 55101 | — |
| United Hospital | Saint Paul | Minnesota | 55102 | — |
| Essentia Health Sandstone | Sandstone | Minnesota | 55072 | — |
| Essentia Health Virginia Clinic | Virginia | Minnesota | 55792 | — |
| Baptist Memorial Hospital and Cancer Center-Golden Triangle | Columbus | Mississippi | 39705 | — |
| Baptist Cancer Center-Grenada | Grenada | Mississippi | 38901 | — |
| Baptist Memorial Hospital and Cancer Center-Union County | New Albany | Mississippi | 38652 | — |
| Baptist Memorial Hospital and Cancer Center-Oxford | Oxford | Mississippi | 38655 | — |
| Baptist Memorial Hospital and Cancer Center-Desoto | Southhaven | Mississippi | 38671 | — |
| Saint Francis Medical Center | Cape Girardeau | Missouri | 63703 | — |
| Siteman Cancer Center at Saint Peters Hospital | City of Saint Peters | Missouri | 63376 | — |
| Siteman Cancer Center at West County Hospital | Creve Coeur | Missouri | 63141 | — |
| Parkland Health Center - Farmington | Farmington | Missouri | 63640 | — |
| Sainte Genevieve County Memorial Hospital | Sainte Genevieve | Missouri | 63670 | — |
| Washington University School of Medicine | St Louis | Missouri | 63110 | — |
| Siteman Cancer Center-South County | St Louis | Missouri | 63129 | — |
| Missouri Baptist Medical Center | St Louis | Missouri | 63131 | — |
| Siteman Cancer Center at Christian Hospital | St Louis | Missouri | 63136 | — |
| Missouri Baptist Sullivan Hospital | Sullivan | Missouri | 63080 | — |
| Community Hospital of Anaconda | Anaconda | Montana | 59711 | — |
| Billings Clinic Cancer Center | Billings | Montana | 59101 | — |
| Bozeman Health Deaconess Hospital | Bozeman | Montana | 59715 | — |
| Benefis Sletten Cancer Institute | Great Falls | Montana | 59405 | — |
| Logan Health Medical Center | Kalispell | Montana | 59901 | — |
| Community Medical Center | Missoula | Montana | 59804 | — |
| Nebraska Medicine-Bellevue | Bellevue | Nebraska | 68123 | — |
| Nebraska Medicine-Village Pointe | Omaha | Nebraska | 68118 | — |
| University of Nebraska Medical Center | Omaha | Nebraska | 68198 | — |
| OptumCare Cancer Care at Charleston | Las Vegas | Nevada | 89102 | — |
| OptumCare Cancer Care at Fort Apache | Las Vegas | Nevada | 89183 | — |
| Renown Regional Medical Center | Reno | Nevada | 89502 | — |
| University of New Mexico Cancer Center | Albuquerque | New Mexico | 87106 | — |
| Roswell Park Cancer Institute | Buffalo | New York | 14263 | — |
| Sanford Bismarck Medical Center | Bismarck | North Dakota | 58501 | — |
| Sanford Broadway Medical Center | Fargo | North Dakota | 58122 | — |
| Sanford Roger Maris Cancer Center | Fargo | North Dakota | 58122 | — |
| Miami Valley Hospital South | Centerville | Ohio | 45459 | — |
| Miami Valley Hospital | Dayton | Ohio | 45409 | — |
| Premier Blood and Cancer Center | Dayton | Ohio | 45409 | — |
| Dayton Physician LLC - Englewood | Dayton | Ohio | 45415 | — |
| Miami Valley Hospital North | Dayton | Ohio | 45415 | — |
| Atrium Medical Center-Middletown Regional Hospital | Franklin | Ohio | 45005-1066 | — |
| Miami Valley Cancer Care and Infusion | Greenville | Ohio | 45331 | — |
| Kettering Medical Center | Kettering | Ohio | 45429 | — |
| Upper Valley Medical Center | Troy | Ohio | 45373 | — |
| University of Oklahoma Health Sciences Center | Oklahoma City | Oklahoma | 73104 | — |
| Saint Alphonsus Cancer Care Center-Ontario | Ontario | Oregon | 97914 | — |
| Lehigh Valley Hospital-Cedar Crest | Allentown | Pennsylvania | 18103 | — |
| UPMC Altoona | Altoona | Pennsylvania | 16601 | — |
| Lehigh Valley Hospital - Muhlenberg | Bethlehem | Pennsylvania | 18017 | — |
| Pocono Medical Center | East Stroudsburg | Pennsylvania | 18301 | — |
| UPMC Hillman Cancer Center Erie | Erie | Pennsylvania | 16505 | — |
| UPMC Cancer Centers - Arnold Palmer Pavilion | Greensburg | Pennsylvania | 15601 | — |
| Lehigh Valley Hospital-Hazleton | Hazleton | Pennsylvania | 18201 | — |
| UPMC Hillman Cancer Center at Rocco And Nancy Ortenzio Cancer Pavilion | Mechanicsburg | Pennsylvania | 17050 | — |
| UPMC Hillman Cancer Center - Monroeville | Monroeville | Pennsylvania | 15146 | — |
| UPMC Hillman Cancer Center | Pittsburgh | Pennsylvania | 15232 | — |
| UPMC-Passavant Hospital | Pittsburgh | Pennsylvania | 15237 | — |
| Sanford Cancer Center Oncology Clinic | Sioux Falls | South Dakota | 57104 | — |
| Sanford USD Medical Center - Sioux Falls | Sioux Falls | South Dakota | 57117-5134 | — |
| Baptist Memorial Hospital and Cancer Center-Collierville | Collierville | Tennessee | 38017 | — |
| Baptist Memorial Hospital and Cancer Center-Memphis | Memphis | Tennessee | 38120 | — |
| UT MD Anderson - The Woodlands | Conroe | Texas | 77384 | — |
| UT MD Anderson Cancer Center | Houston | Texas | 77030 | — |
| UT MD Anderson - West Houston | Houston | Texas | 77079 | — |
| UT MD Anderson - League City | League City | Texas | 77573 | — |
| UT MD Anderson - Sugar Land | Sugar Land | Texas | 77478 | — |
| University of Virginia Cancer Center | Charlottesville | Virginia | 22908 | — |
| Inova Schar Cancer Institute | Fairfax | Virginia | 22031 | — |
| Inova Fairfax Hospital | Falls Church | Virginia | 22042 | — |
| Virginia Cancer Institute | Richmond | Virginia | 23229 | — |
| VCU Massey Cancer Center at Stony Point | Richmond | Virginia | 23235 | — |
| VCU Massey Comprehensive Cancer Center | Richmond | Virginia | 23298 | — |
| VCU Community Memorial Health Center | South Hill | Virginia | 23970 | — |
| Swedish Cancer Institute-Edmonds | Edmonds | Washington | 98026 | — |
| Swedish Cancer Institute-Issaquah | Issaquah | Washington | 98029 | — |
| Valley Medical Center | Renton | Washington | 98055 | — |
| Swedish Medical Center-First Hill | Seattle | Washington | 98122 | — |
| West Virginia University Healthcare | Morgantown | West Virginia | 26506 | — |
| ThedaCare Regional Cancer Center | Appleton | Wisconsin | 54911 | — |
| Duluth Clinic Ashland | Ashland | Wisconsin | 54806 | — |
| ThedaCare Cancer Care - Berlin | Berlin | Wisconsin | 54923 | — |
| Aurora Cancer Care-Southern Lakes VLCC | Burlington | Wisconsin | 53105 | — |
| Aurora Saint Luke's South Shore | Cudahy | Wisconsin | 53110 | — |
| Aurora Health Care Germantown Health Center | Germantown | Wisconsin | 53022 | — |
| Aurora Cancer Care-Grafton | Grafton | Wisconsin | 53024 | — |
| Aurora BayCare Medical Center | Green Bay | Wisconsin | 54311 | — |
| Aurora Cancer Care-Kenosha South | Kenosha | Wisconsin | 53142 | — |
| Aurora Bay Area Medical Group-Marinette | Marinette | Wisconsin | 54143 | — |
| Aurora Cancer Care-Milwaukee | Milwaukee | Wisconsin | 53209 | — |
| Aurora Saint Luke's Medical Center | Milwaukee | Wisconsin | 53215 | — |
| Aurora Sinai Medical Center | Milwaukee | Wisconsin | 53233 | — |
| ThedaCare Regional Medical Center - Neenah | Neenah | Wisconsin | 54956 | — |
| Vince Lombardi Cancer Clinic - Oshkosh | Oshkosh | Wisconsin | 54904 | — |
| Aurora Cancer Care-Racine | Racine | Wisconsin | 53406 | — |
| Vince Lombardi Cancer Clinic-Sheboygan | Sheboygan | Wisconsin | 53081 | — |
| Aurora Medical Center in Summit | Summit | Wisconsin | 53066 | — |
| Vince Lombardi Cancer Clinic-Two Rivers | Two Rivers | Wisconsin | 54241 | — |
| Aurora Cancer Care-Milwaukee West | Wauwatosa | Wisconsin | 53226 | — |
| Aurora West Allis Medical Center | West Allis | Wisconsin | 53227 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT05564403, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Aug 4, 2026 · Synced Oct 17, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT05564403 live on ClinicalTrials.gov.