Bemarituzumab Plus Chemotherapy and Nivolumab Versus Chemotherapy and Nivolumab for FGFR2b Overexpressed Untreated Advanced Gastric and Gastroesophageal Junction Cancer.

Stopped early · Phase 3 · Has a placebo group

Conditions studied: Gastric Cancer, Gastroesophageal Junction Adenocarcinoma

In brief

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.

Key facts

Study ID

NCT05111626

Run by

Amgen

People needed

515

Starts

2022-03-14

Expected to finish

2025-10-29

Last updated by the study team

2026-07-17

Who can join

Age: 18 and older, up to 100. Sex: any. Healthy volunteers: not accepted.

You may not qualify if…

• 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

Where it is running

• Mayo Clinic - Arizona — Phoenix, Arizona, United States
• The Oncology Institute Clinical Research — Cerritos, California, United States
• Cancer and Blood Specialty Clinic — Downey, California, United States
• City of Hope National Medical Center — Duarte, California, United States
• University of California Los Angeles — Los Angeles, California, United States
• University of California Irvine — Orange, California, United States
• Torrance Memorial Physician Network — Redondo Beach, California, United States
• Translational Research in Oncology - US Inc — Santa Monica, California, United States
• Translational Research in Oncology US Inc, Trio Central Pharmacy — Santa Monica, California, United States
• Olive View-University of California in Los Angeles Medical Center — Sylmar, California, United States
• Presbyterian Intercommunity Hospital Health Whitter Hospital — Whittier, California, United States
• Yale New Haven Hospital Yale Cancer Center — New Haven, Connecticut, United States
• Florida Cancer Specialists - Fort Myers — Fort Myers, Florida, United States
• Mayo Clinic — Jacksonville, Florida, United States
• Adventist Health System/Sunbelt, Inc d/b/a AdventHealth Orlando — Orlando, Florida, United States
• Orlando Health Cancer Institute — Orlando, Florida, United States
• University of Illinois Chicago — Chicago, Illinois, United States
• Greater Baltimore Medical Center — Baltimore, Maryland, United States
• Henry Ford Health System — Detroit, Michigan, United States
• Mayo Clinic — Rochester, Minnesota, United States
• Summit Medical Group — Florham Park, New Jersey, United States
• Memorial Sloan Kettering Cancer Center — New York, New York, United States
• Stony Brook University Medical Center — Stony Brook, New York, United States
• FirstHealth Cancer Center — Pinehurst, North Carolina, United States
• Hospital Italiano — Capital Federal, Argentina

Full record on ClinicalTrials.gov

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