A Phase IB/III Study of Bemarituzumab Plus Chemotherapy and Nivolumab Versus Chemotherapy and Nivolumab Alone in Subjects with Previously Untreated Advanced Gastric and Gastroesophageal Cancer with FGFR2b Overexpression
Details
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 mFOLFOX6 and nivolumab to placebo plus mFOLFOX6 and nivolumab as assessed by overall survival.
Eligibility
You can join if...
Inclusion Criteria:
Adult with unresectable, locally advanced or metastatic (not amenable to curative therapy) histologically documented gastric or gastroesophageal junction adenocarcinoma.
Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1
Measurable disease or non-measurable, but evaluable disease, according to Response Evaluation Criteria in Solid Tumours version 1.1 (RECIST v1.1)
You must have no contraindications to mFOLFOX6 chemotherapy or nivolumab
Exclusion Criteria:
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