# ComboMATCH: FOLFOX with or without binimetinib in second-line biliary tract cancer with MAPK pathway alterations

Source: https://onco.cc/trials/combomatch-binimetinib-folfox/  
OnCo record `combomatch-binimetinib-folfox` (Trial). Data CC BY-NC 4.0, attribute "Data from OnCo (onco.cc)"; commercial use needs a licence.

## TL;DR

Part of the American ComboMATCH precision-medicine programme, this trial adds the MEK inhibitor binimetinib to FOLFOX for people whose bile duct or gallbladder cancer carries a KRAS or related pathway mutation, the most common gallbladder cancer drivers.

## Summary

This ComboMATCH treatment trial (NCT05564403) randomises patients with histologically confirmed unresectable or recurrent biliary tract cancer (intrahepatic cholangiocarcinoma, extrahepatic cholangiocarcinoma or gallbladder cancer) and a confirmed RAS/RAF/MEK/ERK pathway mutation by any CLIA-certified method, excluding BRAF V600E, to second-line FOLFOX with or without binimetinib. The primary endpoint is overall survival; 66 patients are planned at 207 US sites, the trial opened in February 2024, is active but no longer recruiting, and lists primary completion in October 2026. KRAS mutations are among the most frequent alterations in gallbladder cancer, and this is one of the few trials that selects biliary patients on MAPK pathway status rather than treating them as one group.

## Fields

- Kind: Trial
- Status: active
- Last checked: 2026-09-24
- Also known as: ComboMATCH biliary
- Registry id: NCT05564403
- Phase: 2
- Setting: Unresectable or recurrent biliary tract cancer (intrahepatic, extrahepatic or gallbladder) with a RAS/RAF/MEK/ERK pathway mutation other than BRAF V600E, after first-line therapy: FOLFOX with or without binimetinib, randomised, primary endpoint overall survival
- Sponsor: National Cancer Institute (NCI)
- Enrolled: 66

## Sources

- ClinicalTrials.gov NCT05564403: https://clinicaltrials.gov/study/NCT05564403

## Connected records

- cancers: [Biliary tract cancer (cholangiocarcinoma)](https://onco.cc/cancers/cholangiocarcinoma/), [Extrahepatic cholangiocarcinoma (perihilar and distal)](https://onco.cc/cancers/extrahepatic-cholangiocarcinoma/), [Gallbladder cancer](https://onco.cc/cancers/gallbladder/), [Intrahepatic cholangiocarcinoma](https://onco.cc/cancers/intrahepatic-cholangiocarcinoma/)
- technologies: [Cytotoxic chemotherapy](https://onco.cc/technologies/cytotoxic-chemotherapy/), [Platinum agents](https://onco.cc/technologies/platinum/), [Small-molecule kinase inhibitors](https://onco.cc/technologies/kinase-inhibitors/)
- targets: [KRAS](https://onco.cc/targets/kras/)
- drugs: [Binimetinib](https://onco.cc/drugs/binimetinib/), [Fluorouracil (5-FU)](https://onco.cc/drugs/fluorouracil/), [FOLFOX (5-FU, leucovorin, oxaliplatin)](https://onco.cc/drugs/folfox/), [Leucovorin (folinic acid)](https://onco.cc/drugs/leucovorin/), [Oxaliplatin](https://onco.cc/drugs/oxaliplatin/)
- terms: [Basket, umbrella, and platform trials](https://onco.cc/terms/basket-umbrella-platform/), [Gallbladder cancer in biliary tract cancer trials (eligibility and subgroups)](https://onco.cc/terms/gallbladder-cancer-in-biliary-trials/)

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