Clinical trialNCT05564403Active, not recruitingPhase 2Interventional

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

SponsorNational Cancer Institute (NCI)Enrollment17Advanced Biliary Tract CarcinomaAdvanced Gallbladder CarcinomaAdvanced Intrahepatic CholangiocarcinomaRecurrent Biliary Tract CarcinomaRecurrent Gallbladder CarcinomaRecurrent Intrahepatic Cholangiocarcinoma+11 more conditions

View the registry record on ClinicalTrials.gov

Summary

The lay summary the sponsor registered on ClinicalTrials.gov.

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.

clinicaltrials.gov ↗

Investigators

The overall officials registered on this study. Names that resolve to a FindMyKOL profile link to it; the rest are shown as registered.

Ardaman Shergill
Alliance for Clinical Trials in Oncology
Principal Investigator
clinicaltrials.gov ↗

A profile link is shown only when the registered name resolves to a person record with a confident, namesake-checked match; ambiguous names stay unlinked.

Sites

207 registered facilities, with the per-site recruitment status where the registry publishes one. ClinicalTrials.gov does not publish per-site enrollment counts.

United States

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
Um Sylvester Comprehensive Cancer Center at Kendall
Miami, Florida, United States
University of Miami Miller School of Medicine-Sylvester Cancer Center
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 Cancer Center - Kuakini
Honolulu, Hawaii, United States
Queen'S Medical Center
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
Advocate Illinois Masonic Medical Center
Chicago, Illinois, United States
John H Stroger Jr Hospital of Cook County
Chicago, Illinois, United States
Northwestern University
Chicago, Illinois, United States
University of Chicago Comprehensive Cancer Center
Chicago, Illinois, United States
Amg Crystal Lake - Oncology
Crystal Lake, Illinois, United States
Carle at the Riverfront
Danville, Illinois, United States
Northwestern Medicine Cancer Center Kishwaukee
DeKalb, Illinois, United States
Cancer Care Specialists of Illinois - Decatur
Decatur, Illinois, United States

167 more sites on the registry record.ClinicalTrials.gov ↗

Site investigator names are published by ClinicalTrials.gov only while a study recruits, so completed studies list sites without them.

Drugs studied

The drug and biological interventions registered on this study, normalized to their RxNorm ingredient where possible.

Binimetinib →Fluorouracil →Leucovorin →Oxaliplatin →

Linked drugs open the directory filtered to KOLs working with them.clinicaltrials.gov ↗

Registration & key dates

Registry attributes as recorded on the ClinicalTrials.gov study record.

Start: 9 Feb 2024
Primary completion: 8 Aug 2026
Completion: 15 Oct 2027
Last update posted: 19 Oct 2026
Registered enrollment: 17
Registry id: NCT05564403

clinicaltrials.gov ↗

Source: ClinicalTrials.gov, via the CTTI AACT database, data as of 4 Nov 2026. Registry facts are shown as registered by the study sponsor; FindMyKOL does not interpret them.