Study of Chemotherapy, With or Without Binimetinib in Advanced Biliary Tract Cancers in 2nd Line … (NCT05564403) | Clinical Trial Compass
Active — Not RecruitingPhase 2
Study of Chemotherapy, With or Without Binimetinib in Advanced Biliary Tract Cancers in 2nd Line Setting (A ComboMATCH Treatment Trial)
United States66 participantsStarted 2024-02-09
Plain-language 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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* 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 availabl…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1This trial is in Phase 2 and is no longer enrolling — does that mean there might be preliminary results or safety data available that could help us understand whether adding binimetinib to chemotherapy is showing any promise for my type of biliary tract cancer?
2Since this is a second-line treatment trial, does that mean I would need to have already tried a first-line chemotherapy regimen to even be considered, and where does this fit in the sequence of treatments you'd recommend for me?
3The trial is testing whether adding binimetinib — a drug that targets a specific cell-signaling pathway — to standard chemotherapy actually improves overall survival; given what you know about my tumor's molecular profile, is there any reason to think my cancer might or might not respond to that kind of approach?
4Because the trial is actively running but no longer recruiting, could my care team access any interim findings, or is there a similar open trial or expanded access option that might give me a chance at this combination if standard second-line chemotherapy isn't enough?
5This trial covers several different subtypes — gallbladder cancer, intrahepatic cholangiocarcinoma, bile duct cancers — so how does the evidence from a mixed group like this apply specifically to my diagnosis, and does the subtype I have affect how my doctor would weigh this against other second-line options?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Overall survival (OS)
Timeframe: From randomization to the time of death due to any cause, assessed up to 30 months