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ACTIVE NOT RECRUITING
NCT05564403
PHASE2

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

Sponsor: National Cancer Institute (NCI)

View on ClinicalTrials.gov

Summary

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.

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

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

66

Start Date

2024-02-09

Completion Date

2026-10-01

Last Updated

2026-04-09

Healthy Volunteers

No

Interventions

DRUG

Binimetinib

Given PO

PROCEDURE

Biopsy Procedure

Undergo biopsy

PROCEDURE

Biospecimen Collection

Undergo collection of blood

PROCEDURE

Bone Scan

Undergo bone scan

PROCEDURE

Computed Tomography

Undergo CT

PROCEDURE

Echocardiography Test

Undergo ECHO

DRUG

Fluorouracil

Given IV

DRUG

Leucovorin Calcium

Given IV

PROCEDURE

Magnetic Resonance Imaging

Undergo MRI

PROCEDURE

Multigated Acquisition Scan

Undergo MUGA

DRUG

Oxaliplatin

Given IV

Locations (209)

University of Alabama at Birmingham Cancer Center

Birmingham, Alabama, United States

University of South Alabama Mitchell Cancer Institute

Mobile, Alabama, United States

Mayo Clinic Hospital in Arizona

Phoenix, Arizona, United States

NEA Baptist Memorial Hospital and Fowler Family Cancer Center - Jonesboro

Jonesboro, Arkansas, United States

UC San Diego Moores Cancer Center

La Jolla, California, United States

Cedars Sinai Medical Center

Los Angeles, California, United States

Presbyterian Intercommunity Hospital

Whittier, California, United States

UM Sylvester Comprehensive Cancer Center at Aventura

Aventura, Florida, United States

UM Sylvester Comprehensive Cancer Center at Coral Gables

Coral Gables, Florida, United States

UM Sylvester Comprehensive Cancer Center at Deerfield Beach

Deerfield Beach, Florida, United States

UF Health Cancer Institute - Gainesville

Gainesville, Florida, United States

Mayo Clinic in Florida

Jacksonville, Florida, United States

University of Miami Miller School of Medicine-Sylvester Cancer Center

Miami, Florida, United States

UM Sylvester Comprehensive Cancer Center at Kendall

Miami, Florida, United States

UM Sylvester Comprehensive Cancer Center at Plantation

Plantation, Florida, United States

Hawaii Cancer Care Inc - Waterfront Plaza

Honolulu, Hawaii, United States

Queen's Cancer Cenrer - POB I

Honolulu, Hawaii, United States

Queen's Medical Center

Honolulu, Hawaii, United States

Queen's Cancer Center - Kuakini

Honolulu, Hawaii, United States

Hawaii Cancer Care - Westridge

‘Aiea, Hawaii, United States

The Queen's Medical Center - West Oahu

‘Ewa Beach, Hawaii, United States

Saint Alphonsus Cancer Care Center-Boise

Boise, Idaho, United States

Saint Luke's Cancer Institute - Boise

Boise, Idaho, United States

Saint Alphonsus Cancer Care Center-Caldwell

Caldwell, Idaho, United States

Kootenai Health - Coeur d'Alene

Coeur d'Alene, Idaho, United States

Saint Luke's Cancer Institute - Fruitland

Fruitland, Idaho, United States

Saint Luke's Cancer Institute - Meridian

Meridian, Idaho, United States

Saint Alphonsus Cancer Care Center-Nampa

Nampa, Idaho, United States

Saint Luke's Cancer Institute - Nampa

Nampa, Idaho, United States

Kootenai Clinic Cancer Services - Post Falls

Post Falls, Idaho, United States

Kootenai Clinic Cancer Services - Sandpoint

Sandpoint, Idaho, United States

Advocate Good Shepherd Hospital

Barrington, Illinois, United States

Northwestern University

Chicago, Illinois, United States

John H Stroger Jr Hospital of Cook County

Chicago, Illinois, United States

University of Chicago Comprehensive Cancer Center

Chicago, Illinois, United States

Advocate Illinois Masonic Medical Center

Chicago, Illinois, United States

AMG Crystal Lake - Oncology

Crystal Lake, Illinois, United States

Carle at The Riverfront

Danville, Illinois, United States

Cancer Care Specialists of Illinois - Decatur

Decatur, Illinois, United States

Decatur Memorial Hospital

Decatur, Illinois, United States

Northwestern Medicine Cancer Center Kishwaukee

DeKalb, Illinois, United States

Advocate Good Samaritan Hospital

Downers Grove, Illinois, United States

Carle Physician Group-Effingham

Effingham, Illinois, United States

Crossroads Cancer Center

Effingham, Illinois, United States

Advocate Sherman Hospital

Elgin, Illinois, United States

Northwestern Medicine Cancer Center Delnor

Geneva, Illinois, United States

Northwestern Medicine Glenview Outpatient Center

Glenview, Illinois, United States

Northwestern Medicine Grayslake Outpatient Center

Grayslake, Illinois, United States

Advocate South Suburban Hospital

Hazel Crest, Illinois, United States

Northwestern Medicine Lake Forest Hospital

Lake Forest, Illinois, United States

AMG Libertyville - Oncology

Libertyville, Illinois, United States

Condell Memorial Hospital

Libertyville, Illinois, United States

Carle Physician Group-Mattoon/Charleston

Mattoon, Illinois, United States

UC Comprehensive Cancer Center at Silver Cross

New Lenox, Illinois, United States

Cancer Care Center of O'Fallon

O'Fallon, Illinois, United States

Advocate Christ Medical Center

Oak Lawn, Illinois, United States

Northwestern Medicine Orland Park

Orland Park, Illinois, United States

University of Chicago Medicine-Orland Park

Orland Park, Illinois, United States

Advocate Lutheran General Hospital

Park Ridge, Illinois, United States

Memorial Hospital East

Shiloh, Illinois, United States

Southern Illinois University School of Medicine

Springfield, Illinois, United States

Springfield Clinic

Springfield, Illinois, United States

Springfield Memorial Hospital

Springfield, Illinois, United States

Carle Cancer Center

Urbana, Illinois, United States

Northwestern Medicine Cancer Center Warrenville

Warrenville, Illinois, United States

UI Health Care Mission Cancer and Blood - Ankeny Clinic

Ankeny, Iowa, United States

UI Health Care Mission Cancer and Blood - Des Moines Clinic

Des Moines, Iowa, United States

UI Health Care Mission Cancer and Blood - Waukee Clinic

Waukee, Iowa, United States

University of Kentucky/Markey Cancer Center

Lexington, Kentucky, United States

Lafayette Family Cancer Center-EMMC

Brewer, Maine, United States

University of Maryland/Greenebaum Cancer Center

Baltimore, Maryland, United States

Walter Reed National Military Medical Center

Bethesda, Maryland, United States

National Institutes of Health Clinical Center

Bethesda, Maryland, United States

UPMC Western Maryland

Cumberland, Maryland, United States

Trinity Health Saint Joseph Mercy Hospital Ann Arbor

Ann Arbor, Michigan, United States

University of Michigan Rogel Cancer Center

Ann Arbor, Michigan, United States

Trinity Health IHA Medical Group Hematology Oncology - Brighton

Brighton, Michigan, United States

Trinity Health Medical Center - Brighton

Brighton, Michigan, United States

University of Michigan - Brighton Center for Specialty Care

Brighton, Michigan, United States

Trinity Health IHA Medical Group Hematology Oncology - Canton

Canton, Michigan, United States

Trinity Health Medical Center - Canton

Canton, Michigan, United States

Chelsea Hospital

Chelsea, Michigan, United States

Trinity Health IHA Medical Group Hematology Oncology - Chelsea Hospital

Chelsea, Michigan, United States

Corewell Health Dearborn Hospital

Dearborn, Michigan, United States

Corewell Health Farmington Hills Hospital

Farmington Hills, Michigan, United States

Cancer Hematology Centers - Flint

Flint, Michigan, United States

Genesee Hematology Oncology PC

Flint, Michigan, United States

Genesys Hurley Cancer Institute

Flint, Michigan, United States

Hurley Medical Center

Flint, Michigan, United States

University of Michigan Health - Sparrow Lansing

Lansing, Michigan, United States

Trinity Health Saint Mary Mercy Livonia Hospital

Livonia, Michigan, United States

Henry Ford Saint John Hospital - Macomb Medical

Macomb, Michigan, United States

Trinity Health Saint Joseph Mercy Oakland Hospital

Pontiac, Michigan, United States

Corewell Health William Beaumont University Hospital

Royal Oak, Michigan, United States

Corewell Health Beaumont Troy Hospital

Troy, Michigan, United States

Huron Gastroenterology PC

Ypsilanti, Michigan, United States

Trinity Health IHA Medical Group Hematology Oncology Ann Arbor Campus

Ypsilanti, Michigan, United States

Sanford Joe Lueken Cancer Center

Bemidji, Minnesota, United States

Mercy Hospital

Coon Rapids, Minnesota, United States

Essentia Health - Deer River Clinic

Deer River, Minnesota, United States

Essentia Health Cancer Center

Duluth, Minnesota, United States

Fairview Southdale Hospital

Edina, Minnesota, United States

Essentia Health Hibbing Clinic

Hibbing, Minnesota, United States

Saint John's Hospital - Healtheast

Maplewood, Minnesota, United States

Abbott-Northwestern Hospital

Minneapolis, Minnesota, United States

Mayo Clinic in Rochester

Rochester, Minnesota, United States

Park Nicollet Clinic - Saint Louis Park

Saint Louis Park, Minnesota, United States

Regions Hospital

Saint Paul, Minnesota, United States

United Hospital

Saint Paul, Minnesota, United States

Essentia Health Sandstone

Sandstone, Minnesota, United States

Essentia Health Virginia Clinic

Virginia, Minnesota, United States

Baptist Memorial Hospital and Cancer Center-Golden Triangle

Columbus, Mississippi, United States

Baptist Cancer Center-Grenada

Grenada, Mississippi, United States

Baptist Memorial Hospital and Cancer Center-Union County

New Albany, Mississippi, United States

Baptist Memorial Hospital and Cancer Center-Oxford

Oxford, Mississippi, United States

Baptist Memorial Hospital and Cancer Center-Desoto

Southhaven, Mississippi, United States

Saint Francis Medical Center

Cape Girardeau, Missouri, United States

Siteman Cancer Center at Saint Peters Hospital

City of Saint Peters, Missouri, United States

Siteman Cancer Center at West County Hospital

Creve Coeur, Missouri, United States

Parkland Health Center - Farmington

Farmington, Missouri, United States

Sainte Genevieve County Memorial Hospital

Sainte Genevieve, Missouri, United States

Washington University School of Medicine

St Louis, Missouri, United States

Siteman Cancer Center-South County

St Louis, Missouri, United States

Missouri Baptist Medical Center

St Louis, Missouri, United States

Siteman Cancer Center at Christian Hospital

St Louis, Missouri, United States

Missouri Baptist Sullivan Hospital

Sullivan, Missouri, United States

BJC Outpatient Center at Sunset Hills

Sunset Hills, Missouri, United States

Community Hospital of Anaconda

Anaconda, Montana, United States

Billings Clinic Cancer Center

Billings, Montana, United States

Bozeman Health Deaconess Hospital

Bozeman, Montana, United States

Benefis Sletten Cancer Institute

Great Falls, Montana, United States

Logan Health Medical Center

Kalispell, Montana, United States

Community Medical Center

Missoula, Montana, United States

Nebraska Medicine-Bellevue

Bellevue, Nebraska, United States

Nebraska Medicine-Village Pointe

Omaha, Nebraska, United States

University of Nebraska Medical Center

Omaha, Nebraska, United States

OptumCare Cancer Care at Seven Hills

Henderson, Nevada, United States

OptumCare Cancer Care at Charleston

Las Vegas, Nevada, United States

OptumCare Cancer Care at Fort Apache

Las Vegas, Nevada, United States

Renown Regional Medical Center

Reno, Nevada, United States

University of New Mexico Cancer Center

Albuquerque, New Mexico, United States

Roswell Park Cancer Institute

Buffalo, New York, United States

Sanford Bismarck Medical Center

Bismarck, North Dakota, United States

Sanford Broadway Medical Center

Fargo, North Dakota, United States

Sanford Roger Maris Cancer Center

Fargo, North Dakota, United States

Miami Valley Hospital South

Centerville, Ohio, United States

Miami Valley Hospital

Dayton, Ohio, United States

Premier Blood and Cancer Center

Dayton, Ohio, United States

Dayton Physician LLC - Englewood

Dayton, Ohio, United States

Miami Valley Hospital North

Dayton, Ohio, United States

Atrium Medical Center-Middletown Regional Hospital

Franklin, Ohio, United States

Miami Valley Cancer Care and Infusion

Greenville, Ohio, United States

Kettering Medical Center

Kettering, Ohio, United States

Upper Valley Medical Center

Troy, Ohio, United States

University of Oklahoma Health Sciences Center

Oklahoma City, Oklahoma, United States

Saint Alphonsus Cancer Care Center-Ontario

Ontario, Oregon, United States

Lehigh Valley Hospital-Cedar Crest

Allentown, Pennsylvania, United States

UPMC Altoona

Altoona, Pennsylvania, United States

Lehigh Valley Hospital - Muhlenberg

Bethlehem, Pennsylvania, United States

Pocono Medical Center

East Stroudsburg, Pennsylvania, United States

UPMC Hillman Cancer Center Erie

Erie, Pennsylvania, United States

UPMC Cancer Centers - Arnold Palmer Pavilion

Greensburg, Pennsylvania, United States

Lehigh Valley Hospital-Hazleton

Hazleton, Pennsylvania, United States

UPMC Hillman Cancer Center at Rocco And Nancy Ortenzio Cancer Pavilion

Mechanicsburg, Pennsylvania, United States

UPMC Hillman Cancer Center - Monroeville

Monroeville, Pennsylvania, United States

University of Pittsburgh Cancer Institute (UPCI)

Pittsburgh, Pennsylvania, United States

UPMC-Passavant Hospital

Pittsburgh, Pennsylvania, United States

Sanford Cancer Center Oncology Clinic

Sioux Falls, South Dakota, United States

Sanford USD Medical Center - Sioux Falls

Sioux Falls, South Dakota, United States

Baptist Memorial Hospital and Cancer Center-Collierville

Collierville, Tennessee, United States

Baptist Memorial Hospital and Cancer Center-Memphis

Memphis, Tennessee, United States

MD Anderson in The Woodlands

Conroe, Texas, United States

M D Anderson Cancer Center

Houston, Texas, United States

MD Anderson West Houston

Houston, Texas, United States

MD Anderson League City

League City, Texas, United States

MD Anderson in Sugar Land

Sugar Land, Texas, United States

University of Virginia Cancer Center

Charlottesville, Virginia, United States

Inova Schar Cancer Institute

Fairfax, Virginia, United States

Inova Fairfax Hospital

Falls Church, Virginia, United States

Virginia Cancer Institute

Richmond, Virginia, United States

VCU Massey Cancer Center at Stony Point

Richmond, Virginia, United States

VCU Massey Comprehensive Cancer Center

Richmond, Virginia, United States

VCU Community Memorial Health Center

South Hill, Virginia, United States

Swedish Cancer Institute-Edmonds

Edmonds, Washington, United States

Swedish Cancer Institute-Issaquah

Issaquah, Washington, United States

Valley Medical Center

Renton, Washington, United States

Swedish Medical Center-First Hill

Seattle, Washington, United States

West Virginia University Healthcare

Morgantown, West Virginia, United States

ThedaCare Regional Cancer Center

Appleton, Wisconsin, United States

Duluth Clinic Ashland

Ashland, Wisconsin, United States

ThedaCare Cancer Care - Berlin

Berlin, Wisconsin, United States

Aurora Cancer Care-Southern Lakes VLCC

Burlington, Wisconsin, United States

Aurora Saint Luke's South Shore

Cudahy, Wisconsin, United States

Aurora Health Care Germantown Health Center

Germantown, Wisconsin, United States

Aurora Cancer Care-Grafton

Grafton, Wisconsin, United States

Aurora BayCare Medical Center

Green Bay, Wisconsin, United States

Aurora Cancer Care-Kenosha South

Kenosha, Wisconsin, United States

Aurora Bay Area Medical Group-Marinette

Marinette, Wisconsin, United States

Aurora Cancer Care-Milwaukee

Milwaukee, Wisconsin, United States

Aurora Saint Luke's Medical Center

Milwaukee, Wisconsin, United States

Aurora Sinai Medical Center

Milwaukee, Wisconsin, United States

ThedaCare Regional Medical Center - Neenah

Neenah, Wisconsin, United States

Vince Lombardi Cancer Clinic - Oshkosh

Oshkosh, Wisconsin, United States

Aurora Cancer Care-Racine

Racine, Wisconsin, United States

Vince Lombardi Cancer Clinic-Sheboygan

Sheboygan, Wisconsin, United States

Aurora Medical Center in Summit

Summit, Wisconsin, United States

Vince Lombardi Cancer Clinic-Two Rivers

Two Rivers, Wisconsin, United States

Aurora Cancer Care-Milwaukee West

Wauwatosa, Wisconsin, United States

Aurora West Allis Medical Center

West Allis, Wisconsin, United States