WithdrawnPhase 1

Phase Ib Trial of Infigratinib In Combination With Atezolizumab And Bevacizumab for The Second-Line Treatment of Advanced Cholangiocarcinoma With FGFR2 Fusion/Amplification

Stopped: Per PI's request

0Started 2023-08-07

Plain-language summary

To find the highest tolerable dose of infigratinib that can be given in combination with bevacizumab and atezolizumab to patients with advanced/metastatic CCA with a FGFR2 mutation.

Who can participate

Age range18 Years

SexALL

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Inclusion criteria

✓. Is male or female aged ≥18 years.
✓. Has histologically confirmed metastatic or advanced unresectable cholangiocarcinoma.
✓. Has disease that is measurable per the RECIST v1.1.
✓. Has FGFR2 fusion in tumor tissue. Presence of the FGFR2 fusion should be determined by CLIA-validated genomic testing of a tumor tissue specimen (DNA-based or RNA-based).
✓. Is refractory to, has demonstrated intolerance to, or has refused access to, available standard therapies. Refractory patients should have evidence of progressive disease on at least one prior standard chemotherapy regimen for advanced or metastatic disease. Patients who discontinued available standard therapy due to toxicity must have continued evidence of measurable disease.
✓. Has archival formalin-fixed, paraffin-embedded primary tumor tissue available or patient is willing to undergo a pretreatment biopsy.
✓. Is able to take oral medication.
✓. Is able to comply with protocol procedures and scheduled visits.

Exclusion criteria

✕5. Men treated or enrolled on this protocol must also agree to use adequate contraception and agree to to refrain from donating sperm prior to the study, for the duration of study participation, and 6 months after completion of bevacizumab+atezolizumab+infigratinib administration.
✕. Patients with untreated CNS metastases are excluded from study
✕. Received treatment with systemic immunosuppressive medication (including, but not limited to, corticosteroids, cyclophosphamide, azathioprine, methotrexate, thalidomide, or anti-TNF-α agents) within 2 weeks prior to initiation of study treatment, or anticipates a need for systemic immunosuppressive medication during study treatment, with the following exceptions:
✕. Received chemotherapy, biologic therapy, immunotherapy, or investigational agent within 4 weeks prior to enrollment.
✕. Received treatment with systemic immunostimulatory agents (including, but not limited to, interferon and interleukin 2 \[IL-2\]) within 4 weeks or 5 half-lives of the drug (whichever is longer) prior to initiation of study treatment
✕. Had previous treatment with any of the following:
✕. Has a history and/or has current evidence of extensive tissue calcification including, but not limited to, the soft tissue, kidneys, intestine, myocardium, vascular system, and lung. Exceptions include calcified lymph nodes, minor pulmonary parenchymal calcifications, and asymptomatic coronary calcifications-these are allowed.
✕. Has history or current evidence of corneal or retinal disorder/keratopathy including, but not limited to, bullous/band keratopathy, inflammation or ulceration, keratoconjunctivitis, or diabetic retinopathy, confirmed by ophthalmic physician. Subjects with asymptomatic ophthalmic conditions assessed by the investigator to pose minimal risk for study participation may be enrolled in the study.

What they're measuring

Incidence of Adverse Events, Graded According to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version (v) 5.0

Timeframe: through study completion; an average of 1 year.

Trial details

NCT IDNCT05510427

SponsorM.D. Anderson Cancer Center

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2023-08-07

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