A ComboMatch Treatment Trial: FOLFOX in Combination with Binimetinib as 2nd Line Therapy for Patients with Advanced Biliary Tract Cancers with MAPK Pathway Alterations

Protocol: ECOG – EAY191-A6

SCHEMA EAY191-A6

Please Note: Below is a brief description of eligibility, please contact Genesys Hurley Cancer Institute, Research Department at (810)762-8181, (810)762-8079, or (810)762-8038 to discuss the full eligibility requirements.

Eligibility:

1. Participants must have histologically confirmed BTC (IHC, EHC or GBC) that is unresectable or recurrent with a confirmed RAS/RAF/MEK/ERK pathway mutation via
   any CLIA-certified method (tumor or ct-DNA). BRAFV600E mutations are not eligible due to other ongoing/upcoming studies in this disease cohort.
2. Measurable disease.
3. Progression of disease on gemcitabine based first-line regimen.
4. No systemic anti-cancer therapy within 4 weeks of registration to EAY191-A6.
5. No prior MEK inhibitor therapy.
6. No prior history of treatment with a direct and specific inhibitor of KRAS.
7. Patients who only received radio-sensitizing chemotherapy with 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.
8. Age ≥ 18 years.
9. ECOG performance status ≤2 (Karnofsky ≥60%)