Actively Recruiting

Phase 1
Phase 2
Age: 18Years +
All Genders
NCT06439485

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

274 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

To learn if pemigatinib in combination with atezolizumab and bevacizumab can help to control cholangiocarcinoma.

CONDITIONS

Official Title

Phase I/II Trial of Pemigatinib in Combination With Atezolizumab and Bevacizumab for Treatment of Advanced Cholangiocarcinoma With FGFR2 Fusion

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Ability to understand and 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 tumor genomic testing
  • Refractory, intolerant to, previously received, or refused first-line systemic therapy including gemcitabine-based therapy with or without immunotherapy
  • Available formalin-fixed, paraffin-embedded primary tumor sample
  • Ability to take oral medication and comply with protocol procedures and visits
  • Eastern Cooperative Oncology Group performance status 0 or 1
  • Adequate hematologic and organ function as defined by specific laboratory criteria within 14 days prior to treatment
  • Negative HIV test or stable on anti-retroviral therapy with CD4 count ≥ 200 and undetectable viral load
  • Negative hepatitis B and C tests or on antiviral therapy if chronic
  • Agree to use appropriate contraception or abstinence during treatment and for 6 months after final dose according to protocol
Not Eligible

You will not qualify if you...

  • Received chemotherapy, biologic therapy, immunotherapy, or investigational agent within 3 weeks before study treatment
  • Prior treatment with selective FGFR inhibitors or VEGFR-targeting agents
  • History or current evidence of extensive tissue calcification except minor allowed types
  • Corneal or retinal disorders with active symptoms as determined by ophthalmic physician
  • Use of potent CYP3A4 inhibitors/inducers or moderate inducers within 14 days before treatment
  • Consumption of grapefruit or related fruits within 7 days prior to first dose
  • Grade 3-4 gastrointestinal bleeding within 3 months prior to enrollment
  • History of thromboembolism within 3 months prior to enrollment
  • Recent use of full-dose anticoagulants or certain antiplatelet therapies
  • Significant cardiovascular disease or uncontrolled hypertension
  • Serious or non-healing wounds, ulcers, or fractures within specified timeframes
  • Major surgery within 28 days prior to enrollment or planned during study
  • Chronic antiplatelet or NSAID therapy except low-dose aspirin
  • History of central nervous system disease or Grade ≥ 2 hemoptysis within 1 month prior to screening
  • History of bleeding disorders or significant coagulopathy
  • History of abdominal fistula, GI perforation, intra-abdominal abscess, or active GI bleeding within 6 months
  • History of leptomeningeal disease or uncontrolled tumor-related pain
  • Uncontrolled pleural, pericardial effusion, or ascites requiring frequent drainage
  • Abnormal calcium/phosphate metabolism or elevated phosphorus or calcium-phosphorus product
  • Active or history of autoimmune disease or immune deficiency with specified exceptions
  • History of certain lung diseases or active pneumonitis
  • Active tuberculosis
  • Recent malignancy other than cholangiocarcinoma within 2 years except low-risk types
  • Severe infection or recent therapeutic antibiotics use
  • Prior allogeneic stem cell or organ transplantation
  • Use of live vaccines within 4 weeks before or during study treatment
  • Use of systemic immunostimulatory or immunosuppressive medications within specified timeframes with exceptions
  • History of severe allergic reactions to study drug components
  • Pregnant or breastfeeding or plans to become pregnant during or within 6 months after treatment
  • History of severe vitamin D deficiency requiring high-dose supplementation

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

MD Anderson Cancer Center

Houston, Texas, United States, 77030

Actively Recruiting

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Research Team

S

Sunyoung Lee, MD,PHD

CONTACT

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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