Study of Bemarituzumab with Chemotherapy and Nivolumab in Untreated Advanced Gastric and Gastroesophageal Junction Cancer Patients with FGFR2b Overexpression
This clinical trial studies the treatment of gastric cancer and gastroesophageal junction cancer with a specific characteristic called FGFR2b overexpression. The study tests a combination of medications including bemarituzumab (also known as AMG 552), nivolumab, and chemotherapy drugs including oxaliplatin, folinic acid, fluorouracil, and capecitabine. Some participants will receive these medications while others will receive chemotherapy and nivolumab with placebo instead of bemarituzumab.
The purpose of the study is to determine if adding bemarituzumab to standard chemotherapy and nivolumab treatment improves survival for patients with previously untreated advanced stomach cancer. The medications are given through intravenous infusion, except for capecitabine which is taken by mouth. The study is conducted in two parts: a smaller initial phase to evaluate safety, followed by a larger phase to compare the effectiveness of the treatments.
During the study, participants will receive regular doses of the study medications and undergo various medical assessments. The treatment period may last for several months, depending on how well the participant responds to the therapy. Doctors will monitor participants’ health status, check for side effects, and evaluate how well the cancer responds to treatment throughout the study period.
1Initial treatment assignment
You will be assigned to one of two treatment groups. Each group receives different combinations of medications.
Your treatment will include either mFOLFOX6 or CAPOX chemotherapy regimen, along with nivolumab.
2Treatment administration – Group 1
If assigned to the first group, you will receive:
– Bemarituzumab through intravenous infusion
– Nivolumab through intravenous infusion
– Chemotherapy medications including oxaliplatin, folinic acid, and fluorouracil through intravenous infusion, or capecitabine taken orally
3Treatment administration – Group 2
If assigned to the second group, you will receive:
– Placebo (instead of bemarituzumab) through intravenous infusion
– Nivolumab through intravenous infusion
– The same chemotherapy medications as Group 1
4Regular assessments
Throughout the treatment, you will undergo:
– Regular physical examinations
– Laboratory tests to monitor your health
– Imaging scans to evaluate your response to treatment
– Quality of life questionnaires
– Visual acuity checks
5Treatment duration
The study will continue until January 2027 or until one of the following occurs:
– Your disease shows progression
– You experience unacceptable side effects
– You decide to stop participating
– Your doctor decides to end your participation
Who Can Join the Study?
Must be an adult diagnosed with advanced stomach or gastroesophageal junction cancer that cannot be surgically removed or has spread to other parts of the body
Must have a good level of physical function, scoring 0 or 1 on the ECOG scale (a measure of daily living abilities)
Must have disease that can be measured or evaluated using specific imaging criteria
Must be able to receive treatment with nivolumab (an immunotherapy medication) and chemotherapy medications
Must have adequate organ function, including:
Sufficient blood cell counts
Normal or near-normal liver function
Adequate kidney function
Normal or stable blood clotting measures
For Phase 3 participants:
No previous treatment for advanced disease except maximum one dose of chemotherapy with or without nivolumab
Previous cancer treatments must have been completed more than 6 months before starting the study
Must have confirmed presence of specific protein (FGFR2b) in tumor tissue
Must be able to take oral medication (for patients receiving specific chemotherapy combination called CAPOX)
Who Cannot Join the Study?
Prior treatment with FGFR inhibitors (medications that target specific proteins involved in cancer growth)
Previous treatment with immune checkpoint inhibitors (drugs that help the immune system fight cancer)
Active or untreated brain metastases (cancer that has spread to the brain)
Uncontrolled high blood pressure
Major surgery within 28 days before starting the study treatment
Active or chronic infections, including hepatitis B, hepatitis C, or HIV
Significant heart problems in the past 6 months
Other types of cancer within the last 3 years (except for successfully treated non-melanoma skin cancer or cervical cancer in situ)
Autoimmune diseases requiring systemic treatment (conditions where the immune system attacks healthy cells)
Pregnant or breastfeeding women
Known allergies to study medications or their components
Participation in another clinical trial within 28 days before starting this study
Serious medical conditions that could interfere with study participation
Bemarituzumab
This is a targeted therapy medication that works by targeting a specific protein called FGFR2b found on some cancer cells. It is being studied in the treatment of gastric (stomach) and gastroesophageal junction cancer.
Nivolumab
This is an immunotherapy medication that helps your immune system fight cancer cells. It works by blocking a protein that prevents your immune system from attacking cancer cells, allowing your body’s immune system to better fight the cancer.
FOLFOX
This is a combination chemotherapy treatment that includes several medications used together to treat cancer. It is commonly used to treat various types of gastrointestinal cancers, including stomach cancer. The combination includes fluorouracil, leucovorin, and oxaliplatin.
Gastric and Gastroesophageal Junction Cancer – A disease that begins when cancer cells form in the tissues of the stomach or the area where the stomach connects to the esophagus (gastroesophageal junction). In this specific type, there is an overexpression of a protein called FGFR2b in the cancer cells. The cancer typically develops slowly over many years, starting with changes in the inner lining of these organs. As the disease progresses, it can grow through the stomach’s wall and spread to nearby lymph nodes and other organs. This particular form of cancer is characterized by abnormal cell growth driven by excessive amounts of FGFR2b protein on the surface of cancer cells.
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