Pemigatinib + Durvalumab for Liver Cancer

Recruiting in 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.

Inclusion Criteria

1. Written informed consent and HIPAA authorization for release of personal health information prior to registration. NOTE: HIPAA authorization may be included in the informed consent or obtained separately.

2. Age ≥ 18 years at the time of consent.

3. ECOG Performance Status of 0 or 1 within 7 days prior to Cycle 1 Day 1.

+7 more

Participant Groups

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: