uso 21326
Estudio de fase 1b/3 de bemarituzumab más quimioterapia y nivolumab frente a quimioterapia y nivolumab solos en sujetos con cáncer de la unión gástrica y gastroesofágica avanzado no tratado previamente y con sobreexpresión de FGFR2b (FORTITUDE-102 (20210098))
Tipos de enfermedades: Investigación sobre el cáncer gastrointestinal
Requisitos de elegibilidad:
-Unresectable locally advanced or metastatic gastric or GE junction adenocarcinoma with evaluable disease that is eligible for treatment with mFOLFOX6 and nivolumab and study confirmed FGFR2 b overexpression
-No: prior treatment in advanced or metastatic setting except for 1 dose of mFOLFOX6 with or without nivolumab; prior treatment with selective inhibitors of FGF-FGFR pathway; known HER2+ status; untreated or symptomatic CNS metastasis or leptomeningeal disease; clinically significant cardiac disease; peripheral sensory neuropathy grade 2 or higher; history of malignancy within last 2 years (definitively treated cancers allowed); known HIV infection with CD4+ T-cell count < 350 cells/uL, Hep C or Hep B infection (sustained virologic response after antiviral therapy allowed); history of interstitial lung disease; solid organ transplant; active autoimmune disease requiring systemic treatment within last 2 years (except for replacement therapy) or other need for chronic immunosuppressive treatment; history of or ongoing chronic use of ophthalmic steroids; ongoing ophthalmologic abnormalities or symptoms that are acute or actively progressing; not willing to abstain from contact lens use; conditions or known abnormalities of the eye that would increase risk of developing corneal ulcerations; corneal surgery or ophthalmic laser procedures within last 6 months.
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