Actively Recruiting
A Phase II Study of Pemigatinib Plus Durvalumab in Previously Treated Advanced Intrahepatic Cholangiocarcinoma Patients With FGFR-2 Fusion or Rearrangement
Led by Mehmet Akce · Updated on 2026-05-08
38
Participants Needed
2
Research Sites
74 weeks
Total Duration
On this page
Sponsors
M
Mehmet Akce
Lead Sponsor
A
AstraZeneca
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
A Phase II Study of Pemigatinib Plus Durvalumab in Previously Treated Advanced Intrahepatic Cholangiocarcinoma Patients With FGFR-2 Fusion or Rearrangement
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Provide written informed consent and HIPAA authorization
- Age 18 years or older
- ECOG performance status of 0 or 1
- Body weight greater than 30 kg
- Histologically confirmed locally advanced unresectable or metastatic intrahepatic cholangiocarcinoma with FGFR-2 fusion or rearrangement detected by certified assays
- Measurable disease per RECIST 1.1 criteria
- Prior treatment with gemcitabine, cisplatin, and durvalumab or another anti-PD-1 antibody with progression, intolerance, or at least 6 months of stable disease or partial response
- Adequate organ function including specific blood count and liver function parameters
- Negative pregnancy test for females of childbearing potential
- Willingness to use effective contraception if applicable
- Ability and willingness to comply with study procedures and visits
- Life expectancy of at least 12 weeks
You will not qualify if you...
- Prior therapy with a FGFR inhibitor
- Significant corneal or retinal disorders confirmed by eye examination
- History of systemic mineral imbalance causing ectopic calcification
- Use of potent CYP3A4 inhibitors or inducers within 14 days before study drug
- History of severe vitamin D deficiency requiring high-dose supplementation
- Participation in another investigational clinical study within 3 months
- Concurrent enrollment in another interventional clinical study
- Receipt of anticancer therapy within 28 days prior to study drug
- Unresolved toxicity from previous anticancer therapy of grade 2 or higher (with some exceptions)
- Concurrent cancer treatments other than allowed hormonal therapy
- Recent major radiotherapy or surgery within specified time frames
- History of organ transplantation
- Active or prior autoimmune or inflammatory disorders with some exceptions
- Uncontrolled illnesses or infections that may affect participation
- History of other malignancies with specific exceptions
- Presence of leptomeningeal carcinomatosis or untreated brain metastases
- Prolonged QTc interval on ECG
- Active primary immunodeficiency
- Active hepatitis B, C, or HIV infection
- Active tuberculosis infection
- Use of immunosuppressive medication within 14 days before durvalumab with exceptions
- Receipt of live vaccines within 30 days prior to study
- Pregnancy, breastfeeding, or unwillingness to use contraception
- Known allergy to study drugs or excipients
- Prior enrollment in durvalumab clinical studies
- Severe immune-related adverse events from prior immunotherapy
- Investigator judgment of unsuitability for study participation
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 2 locations
1
University of Alabama at Birmingham
Birmingham, Alabama, United States, 35294
Actively Recruiting
2
Roswell Park Cancer Institute
Buffalo, New York, United States, 14263
Actively Recruiting
Research Team
M
Mehmet Akce, MD
CONTACT
A
Ahran Lee
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here