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Recruiting Phase 1, Phase 2 NCT06439485

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

Trial Parameters

Condition Advanced Cholangiocarcinoma
Sponsor M.D. Anderson Cancer Center
Study Type INTERVENTIONAL
Phase Phase 1, Phase 2
Enrollment 25
Sex ALL
Min Age 18 Years
Max Age N/A
Start Date 2024-11-19
Completion 2028-02-22
Interventions
PemigatinibAtezolizumabBevacizumab

Brief Summary

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

Eligibility Criteria

Inclusion Criteria: * Ability to understand and willingness to sign informed consent. * Age ≥18 years. * Has histologically confirmed metastatic or advanced unresectable cholangiocarcinoma. * Has disease that is measurable per the RECIST v1.1. * Has at least one measurable target lesion. * Has FGFR2 fusion or rearrangement in tumor tissue, as determined by CLIA-validated genomic testing of a tumor tissue specimen (DNA-based or RNA-based). * Is refractory to, has demonstrated intolerance to, had received, or has refused access to, the 1st line systemic therapy including gemcitabine-based therapy with or without immunotherapy including durvalumab or pembrolizumab. Participants who discontinued available standard therapy due to toxicity must have continued evidence of measurable disease. * Has available a formalin-fixed, paraffin-embedded primary tumor sample. * Is able to take oral medication and to comply with protocol procedures and scheduled visits.. * Has Eastern Cooperative Oncology

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