Bemarituzumab Plus Chemotherapy and Nivolumab Versus Chemotherapy and Nivolumab for FGFR2b Overexpressed Untreated Advanced Gastric and Gastroesophageal Junction Cancer
Trial ID or NCT#
The main objective of Part 1 is to evaluate the safety and tolerability of bemarituzumab plus 5-fluorouracil, leucovorin, and oxaliplatin (mFOLFOX6) and nivolumab. The main objective Part 2 is to compare efficacy of bemarituzumab plus chemotherapy (mFOLFOX6 or capecitabine combined with oxaliplatin (CAPOX)) and nivolumab to placebo plus chemotherapy (mFOLFOX6 or CAPOX) and nivolumab as assessed by overall survival.
A Phase 1b/3 Study of Bemarituzumab Plus Chemotherapy and Nivolumab Versus Chemotherapy and Nivolumab Alone in Subjects With Previously Untreated Advanced Gastric and Gastroesophageal Junction Cancer With FGFR2b Overexpression
- - Prior treatment with any selective inhibitor of the fibroblast growth factor (FGF)-FGFR pathway - Known positive human epidermal growth factor receptor 2 (HER2) status - Untreated or symptomatic central nervous system disease metastases and leptomeningeal disease - Peripheral sensory neuropathy grade 2 or higher - Clinically significant cardiac disease - Other malignancy within the last 2 years (exceptions for definitively treated disease) - Chronic or systemic ophthalmologic disorders - Major surgery or other investigational study within 28 days prior to randomization - Palliative radiotherapy within 14 days prior to randomization - Abnormalities of the cornea that may pose an increased risk of developing a corneal ulcer - Active autoimmune disease that has required systemic treatment (except replacement therapy) within the past 2 years or any other diseases requiring immunosuppressive therapy while on study
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