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
52 weeks
Total Duration
On this page
Sponsors
M
Mehmet Akce
Lead Sponsor
A
AstraZeneca
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating the combination of pemigatinib and durvalumab in adults with advanced intrahepatic cholangiocarcinoma who have FGFR-2 fusion or rearrangement. This single-arm phase II study focuses on patients previously treated for this condition to understand how this combination therapy affects tumor response over time. Participants will receive pemigatinib orally at 13.5 mg daily for two weeks followed by one week off in each 21-day cycle. Durvalumab is given intravenously at 1500 mg every three weeks on the first day of each cycle. Treatment continues until disease progression, unacceptable side effects, or a decision by the patient or physician, for up to 24 months or about 35 cycles. Before each cycle, participants will have lab tests and clinical visits to monitor health and treatment effects. Disease response will be assessed every 9 weeks using imaging and criteria known as RECIST 1.1. Researchers will track tumor response, survival, disease control, duration of response, and side effects throughout the study period.
CONDITIONS
Brief 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
- Be 18 years or older at time of consent
- Have ECOG performance status of 0 or 1
- Weigh more than 30 kg
- Have histologically confirmed locally advanced unresectable or metastatic intrahepatic cholangiocarcinoma with FGFR-2 fusion or rearrangement detected by certified assays
- Have measurable disease according to RECIST 1.1 criteria
- Have received prior gemcitabine, cisplatin, and durvalumab or another anti-PD-1 antibody with progression, intolerance, or at least 6 months of stable disease or partial response
- Demonstrate adequate organ function as defined by specific lab values
- Females of childbearing potential must have a negative pregnancy test
- Use effective contraception if sexually active and of reproductive potential
- Be willing and able to comply with study procedures including treatment and visits
- Have a life expectancy of at least 12 weeks
You will not qualify if you...
- Prior therapy with any FGFR inhibitor
- Significant eye disorders confirmed by exam
- History of calcium and phosphate imbalance with soft tissue calcification
- Use of potent CYP3A4 inhibitors or inducers within 14 days before study drug
- History of severe vitamin D deficiency requiring high doses
- Participation in another investigational clinical study within last 3 months
- Concurrent enrollment in another interventional clinical study
- Recent anticancer therapy within 28 days before study drug
- Unresolved toxicities from prior therapies of grade 2 or higher except certain exceptions
- Concurrent chemotherapy or biologic therapy for cancer treatment
- Recent radiotherapy to over 30% bone marrow or wide field radiation within 4 weeks
- Major surgery within 28 days prior to study drug, except local palliative surgery
- History of allogenic organ transplantation
- Active or prior autoimmune or inflammatory disorders with some exceptions
- Uncontrolled illnesses including infections, heart conditions, or psychiatric issues limiting compliance
- History of another primary malignancy except specific treated conditions
- History of leptomeningeal carcinomatosis
- Untreated or unstable brain metastases or spinal cord compression
- Prolonged QT interval on ECG
- Active primary immunodeficiency
- Known active hepatitis B, C, or HIV infection with some exceptions
- Use of immunosuppressive medication within 14 days before durvalumab with exceptions
- Recent live vaccine use within 30 days before study drug
- Pregnancy or breastfeeding or unwillingness to use birth control
- Known allergy to study drugs or their ingredients
- Prior treatment in a durvalumab clinical study
- Prior anti-PD-1 or anti-PD-L1 immunotherapy with certain immune-related adverse events
- Investigator judgment of unsuitability for study participation or compliance
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
screening and enrollment visit
Duration - Repeated 21-day cycles until disease progression or discontinuation
Participants receive oral Pemigatinib daily for 14 days followed by 7 days off in each 21-day cycle, along with Durvalumab administered intravenously every 3 weeks on Day 1 of each cycle.
Visits every 3 weeks for drug administration and monitoring
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
A
Ahran Lee
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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