RecruitingPhase 2NCT06728410

A Phase II Study of Pemigatinib Plus Durvalumab in Previously Treated Advanced Intrahepatic Cholangiocarcinoma Patients With FGFR-2 Fusion or Rearrangement

A Phase II Study of Pemigatinib Plus Durvalumab (MEDI4736) in Previously Treated Advanced Intrahepatic Cholangiocarcinoma Patients With FGFR-2 Fusion or Rearrangement


Sponsor

Mehmet Akce

Enrollment

38 participants

Start Date

Jan 27, 2026

Study Type

INTERVENTIONAL

Conditions

Summary

This is a single arm phase II study of pemigatinib and durvalumab combination in patients with FGFR-2 fusion or rearrangement positive intrahepatic cholangiocarcinoma. Each cycle will be 3 weeks. Pemigatinib is administered at 13.5 mg orally daily 2 weeks on and 1 week off. Durvalumab is administered at 1500 mg intravenously once every 3 weeks. Subjects will require a visit with appropriate laboratory work prior to the start of each cycle. Disease assessment will occur every 9 weeks. Subjects will continue treatment until progression per RECIST 1.1, toxicity or subject/physician decision. A maximum of 24 months (about 35 cycles) of pemigatinib and durvalumab treatment from Cycle 1 Day 1 is allowed.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This Phase II study is testing a combination of two drugs — pemigatinib (a targeted therapy) and durvalumab (an immunotherapy) — in people with a bile duct cancer called intrahepatic cholangiocarcinoma that has a specific genetic change (FGFR2 fusion or rearrangement). The trial is for patients whose cancer has progressed after prior treatment. **You may be eligible if...** - You are 18 or older - You have been diagnosed with locally advanced or metastatic intrahepatic cholangiocarcinoma (bile duct cancer) - Your tumor has a confirmed FGFR2 fusion or rearrangement (via an approved genetic test) - You have received prior treatment including gemcitabine, cisplatin, and an anti-PD-1 drug, and your cancer has progressed or you could not tolerate chemotherapy - You have at least one measurable tumor on scans - Your organ function meets required thresholds - You are willing to use effective contraception **You may NOT be eligible if...** - You have had prior treatment with an FGFR inhibitor drug - You have significant eye problems (corneal or retinal disorders) - You have active autoimmune disease (like lupus, Crohn's, or rheumatoid arthritis) - You have active hepatitis B, C, or HIV - You have active brain metastases or history of organ transplant - You are pregnant or breastfeeding Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

Interested in this trial?

Get notified about updates and connect with the research team.

Interventions

DRUGPemigatinib

Pemigatinib 13.5 mg

DRUGDurvalumab

Durvalumab 1500 mg IV


Locations(2)

University of Alabama at Birmingham

Birmingham, Alabama, United States

Roswell Park Cancer Institute

Buffalo, New York, United States

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

Visit

NCT06728410


Related Trials