Actively Recruiting
Phase I/II Trial of Pemigatinib in Combination With Atezolizumab and Bevacizumab for Treatment of Advanced Cholangiocarcinoma With FGFR2 Fusion
Led by M.D. Anderson Cancer Center · Updated on 2026-01-14
25
Participants Needed
1
Research Sites
104 weeks
Total Duration
On this page
Sponsors
M
M.D. Anderson Cancer Center
Lead Sponsor
I
Incyte Corporation
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating the combination of pemigatinib, atezolizumab, and bevacizumab to see if it can help control advanced cholangiocarcinoma with FGFR2 fusion. This Phase I/II trial aims to assess the treatment's antitumor activity, safety, and determine the best dose for further study. The trial also explores the immune environment changes and genetic markers related to treatment response and resistance. Participants in Part 1 will receive one of two doses of pemigatinib along with atezolizumab and bevacizumab, with up to six participants tested at each dose level to identify the recommended Phase 2 dose. In Part 2, participants will receive pemigatinib at the dose determined from Part 1, combined with the other two drugs. Treatments are given by mouth and intravenously according to the study protocol. During the study, participants will be monitored for safety and adverse events for about one year. Researchers will evaluate tumor response using imaging scans, lab tests, and clinical assessments. They will also track progression-free survival, overall survival, and duration of response. The study includes blood and tissue sample analysis to study treatment effects and resistance. Participant involvement includes regular visits for treatment, monitoring, and follow-up assessments throughout the trial.
CONDITIONS
Brief Title
Phase I/II Trial of Pemigatinib in Combination With Atezolizumab and Bevacizumab for Treatment of Advanced Cholangiocarcinoma With FGFR2 Fusion
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Ability to understand and willingness to sign informed consent
- Age 18 years or older
- Histologically confirmed metastatic or advanced unresectable cholangiocarcinoma
- Disease measurable per RECIST v1.1 with at least one measurable target lesion
- FGFR2 fusion or rearrangement confirmed by CLIA-validated genomic testing
- Refractory to, intolerant of, or refused first-line systemic therapy including gemcitabine-based therapy with or without immunotherapy
- Available formalin-fixed, paraffin-embedded primary tumor sample
- Able to take oral medication and comply with study procedures
- Eastern Cooperative Oncology Group performance status of 0 or 1
- Adequate hematologic and organ function based on defined laboratory tests
- Negative HIV, hepatitis B, and hepatitis C tests with exceptions for stable controlled infections
- Agree to contraception requirements if of childbearing potential
You will not qualify if you...
- Prior chemotherapy, biologic therapy, immunotherapy, or investigational agent within 3 weeks before study
- Previous treatment with selective FGFR inhibitors or VEGFR-targeting agents
- History or evidence of extensive tissue calcification or significant corneal/retinal disorders
- Use of potent CYP3A4 inhibitors or inducers within 14 days before study
- Consumption of grapefruit or related products within 7 days prior to study
- Recent Grade 3-4 gastrointestinal bleed or thromboembolism within 3 months
- Significant cardiovascular disease or uncontrolled hypertension
- Recent major surgery or non-healing wounds within specified time frames
- Current chronic antiplatelet or NSAID therapy exceeding allowed doses
- History of central nervous system disease or significant bleeding disorders
- Active or recent infections including tuberculosis
- History of malignancy other than cholangiocarcinoma within 2 years
- Use of systemic immunosuppressive or immunostimulatory agents within specified periods
- Known hypersensitivity to study drugs or related components
- Pregnancy, breastfeeding, or intent to become pregnant during or shortly after study
- History of hypovitaminosis D requiring high-dose supplementation
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.
1 visit (in-person)
Duration - Up to 1 year or until disease progression or unacceptable side effects
Participants receive a combination of pemigatinib, atezolizumab, and bevacizumab to treat advanced cholangiocarcinoma with FGFR2 fusion. The dose of pemigatinib may vary depending on the study part and tolerance.
Regular visits during treatment for dosing and safety assessments
Trial Site Locations
Total: 1 location
1
MD Anderson Cancer Center
Houston, Texas, United States, 77030
Actively Recruiting
Research Team
S
Sunyoung Lee, MD,PHD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
2
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