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

Phase 3 Terminated 515 enrolled Amgen

RandomizedSequentialDouble-blindTreatment

Summary

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.

Timeline

Start: 2022-03-14
Primary completion: 2025-10-14
Completion: 2025-10-29

Outcome

Outcome not reported

Stopped: “Study was terminated by sponsor”

Publications

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Bemarituzumab	Monoclonal antibody	—	Intravenous
Background	Capecitabine	Small molecule	—	Oral
Background	Leucovorin	Small molecule	—	Intravenous
Background	Nivolumab	Monoclonal antibody	—	Intravenous
Background	Oxaliplatin	Small molecule	—	Intravenous
Background	fluorouracil	Small molecule	—	Intravenous