Bemarituzumab Plus Chemotherapy and Nivolumab Versus Chemotherapy and Nivolumab for FGFR2b Overexpressed Untreated Advanced Gastric and Gastroesophageal Junction Cancer
Trial ID or NCT#
NCT05111626
Status
NOT RECRUITING
Purpose
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.
Official Title
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
Eligibility Criteria
Ages Eligible for Study: 18 Years to 100 Years
Sexes Eligible for Study: All
Accepts Healthy Volunteers: No
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
Investigator(s)
George A. Fisher Jr.
Medical oncologist,
Gastrointestinal specialist
Colleen Haas Chair in the School of Medicine
Contact us to find out if this trial is right for you.
Contact
Flordeliza Mendoza
650-724-2056
View on ClinicalTrials.gov