Pemigatinib + Durvalumab for Liver Cancer

Palo Alto (17 mi)

Overseen byMehmet Akce, MD

Age: 18+

Sex: Any

Travel: May be covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Waitlist Available

Sponsor: Mehmet Akce

No Placebo Group

Prior Safety Data

Breakthrough Therapy

Trial Summary

What is the purpose of this trial?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 Criteria

This trial is for patients who have already been treated for advanced intrahepatic cholangiocarcinoma, a type of liver cancer, and have specific genetic changes called FGFR-2 fusion or rearrangement. Participants must meet certain health standards and agree to regular visits with lab work.

Treatment Details

The study tests a combination of two drugs: Pemigatinib taken orally in cycles (2 weeks on, 1 week off) and Durvalumab given intravenously every 3 weeks. Patients will be monitored every 9 weeks to assess the treatment's effect on their disease over up to 24 months.

1Treatment groups

Experimental Treatment

Group I: Pemigatinib + DurvalumabExperimental Treatment2 Interventions

Pemigatinib 13.5 mg will be taken orally at the same time each day for 14 days (Day 1 through Day 14), followed by 7 days off treatment (Day 15 through Day 21) of each 21 day cycle. Durvalumab 1500 mg IV will be administered every 3 weeks on Day 1 of each 21-day cycle.

Durvalumab is already approved in European Union, United States, Japan for the following indications:

🇪🇺 Approved in European Union as Imfinzi for: