Full 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 (FORTITUDE 102)Purpose
The purpose of this study is to see if adding bemarituzumab to chemotherapy and immunotherapy is better than chemotherapy and immunotherapy alone in people with advanced cancer of the stomach or the junction between the stomach and esophagus (gastroesophageal junction, GEJ) whose tumors express FGFR2b. The chemotherapy drugs used in this study are mFOLFOX6 (a combination of 5-fluorouracil, leucovorin, and oxaliplatin) and the immunotherapy is nivolumab.
Bemarituzumab blocks a protein called FGFR2b that promotes cancer growth. Nivolumab works by boosting the power of the immune system to find and kill cancer cells. Participants will be randomly assigned to receive chemotherapy and immunotherapy with either bemarituzumab or a placebo. The treatments in this study are given intravenously (by vein).
Who Can Join
To be eligible for this study, patients must meet several requirements, including:
- Participants must have inoperable or metastatic gastric or GEJ cancer that has come back or continued to grow despite prior treatment.
- Patients’ tumor tissue must make the FGFR2b protein.
- Patients may not have received treatment for advanced cancer.
- The serious side effects of prior therapies must go away before the study treatment is given.
- Patients must be physically well enough that they are able to be mobile, take care of themselves, and engage in all but physically strenuous activities. For example, they must be well enough that they could carry out office work or light housework.
- This study is for people age 18 and older.
Contact
For more information and to ask about eligibility for this study, please contact the office of Dr. Steven Maron at 646-888-6780.