FORTITUDE-102: This phase Ib/III study is evaluating the safety and effectiveness of targeted therapy (bemarituzumab), compared to a placebo, when combined with chemotherapy (mFOLFOX6) and immunotherapy (nivolumab) in people with previously untreated, advanced stomach and gastro-oesophageal junction cancer with FGFR2b overexpressionA 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

Summary

This study is being conducted in two parts. Part 1 (the phase Ib part) is evaluating how safe and tolerable bemarituzumab plus 5-fluorouracil, leucovorin, and oxaliplatin (mFOLFOX6) and nivolumab are when combined. Participants in this part will receive bemarituzumab at different doses (via intravenous [IV] infusion), with mFOLFOX6 (administered via IV) and nivolumab (via IV) to determine the recommended phase 3 dose (RP3D). Part 2 of the study (the Phase III section) is evaluating the efficacy of bemarituzumab plus mFOLFOX6 and nivolumab to placebo plus mFOLFOX6 and nivolumab. Eligible participants will be randomly allocated to either the experimental arm or placebo control arm. In the Experimental Arm, participants will receive bemarituzumab (administered via IV at the RP3D), in combination with mFOLFOX6 (via IV) and nivolumab (via IV). In the Placebo Comparator arm, participants will receive a placebo (via IV) in combination with mFOLFOX6 (via IV) and nivolumab (via IV).