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

Running, not enrolling · Phase 2

Conditions studied: 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

In brief

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.

Key facts

Study ID: NCT05564403
Run by: National Cancer Institute (NCI)
People needed: 66
Starts: 2024-02-09
Expected to finish: 2026-10-01
Last updated by the study team: 2026-08-04

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

Patient must have enrolled onto EAY191 and must have been given a treatment assignment to ComboMATCH to EAY191-A6 based on the presence of an actionable mutation as defined in EAY191
GENERAL COMBOMATCH EAY191:
Patients must be registered to the ComboMATCH Registration Protocol (EAY191)
Patients must have RAS/RAF/MEK/ERK mutations as determined by the ComboMATCH screening assessment
Patients must not have BRAF V600E as determined by the ComboMATCH screening assessment
Patients must have disease that can be safely biopsied and agree to a pre-treatment biopsy or have archival tissue available from within 12 months prior to registration on the ComboMATCH Registration Trial (EAY191).
Please note the current actionable marker of interest (aMOI)/actionable alteration list for this treatment trial can be found on the Cancer Trials Support Unit (CTSU) website
Please note novel/Dynamic aMOI can be submitted for review per the process described in the ComboMATCH Registration Protocol
EAY191-A6 REGISTRATION:
Participants must have histologically confirmed BTC (intrahepatic cholangiocarcinoma [IHC], extrahepatic cholangiocarcinoma [EHC] or gallbladder cancer [GBC]) that is unresectable or recurrent with a confirmed RAS/RAF/MEK/ERK pathway mutation via any Clinical Laboratory Improvement Act (CLIA)-certified method. BRAFV600E mutations are not eligible due to other ongoing/upcoming studies in this disease cohort
Tumor tissue must be available:
Adequate archival tumor specimen (obtained within 12 months of EAY191 registration which has not had a Response Evaluation Criteria in Solid Tumors (RECIST) response, complete response (CR) or partial response (PR), to any intervening therapy after collection of the tissue) must be available with formalin-fixed paraffin-embedded tumor tissue (blocks or slides) OR
Consent to a new tumor tissue biopsy which is not a representative target lesion. This lesion must be amenable to a minimal risk image-guided or direct vision biopsy
A new biopsy is preferred but is not required for enrollment in EAY191-A6 if sufficient archival tissue is available as described above.
Measurable disease per RECIST 1.1 Of note, in the case when a baseline biopsy is done after scans are obtained, a lesion separate from one that is biopsied needs to be measurable per RECIST 1.1. All radiologic studies must be performed within 28 days prior to registration
Progression of disease on gemcitabine based first-line regimen (i.e. only one prior line of therapy is permitted)
No systemic anti-cancer therapy within 4 weeks of registration to EAY191-A6
No prior MEK inhibitor therapy
No prior history of treatment with a direct and specific inhibitor of KRAS
Patients who only received radio-sensitizing chemotherapy with fluorouracil (5-FU) or capecitabine are eligible, but need to have received and failed first-line systemic chemotherapy upon recurrence. Peri-operative systemic 5-FU/capecitabine and/or oxaliplatin, is allowed if it's been more than 12 months of registration to EAY191-A6
No major surgery within 4 weeks (excluding placement of vascular access) of registration to EAY191-A6
No minor surgery within 2 weeks of registration to EAY191-A6
No palliative radiotherapy within 1 week of registration to EAY191-A6
Not pregnant and not nursing, because this study involves an investigational agent whose genotoxic, mutagenic and teratogenic effects on the developing fetus and newborn are unknown
Therefore, for women of childbearing potential only, a negative pregnancy test done =< 14 days prior to registration is required

Where it is running

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
University of Alabama at Birmingham Cancer Center — Birmingham, Alabama, United States

Full record on ClinicalTrials.gov

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