Modified FOLFOX Plus/Minus Nivolumab and Ipilimumab vs. FLOT Plus Nivolumab in Patients With Previously Untreated Advanced or Metastatic Gastric Cancer

Summary

Patients with Her2 negative, previously untreated metastatic esophagogastric adenocarcinoma will be treated with modified FOLFOX, with modified FOLFOX plus Nivolumab and Ipilimumab or FLOT plus Nivolumab. The groups will be compared for time until progression of the disease (primary endpoint) as well as for response to the treatment, overall survival, safety/tolerability of the treatment and quality of life.

Timeline

Start

2018-11-07

Primary completion

2024-07-19

Completion

2024-07-19

Publications

• Lorenzen S, Goetze TO, Thuss-Patience PC, Riera-Knorrenschild J, Goekkurt E, Dechow TN, Ettrich TJ, Hofheinz RD, Luley KB, Pink D, Lindig U, Folprecht G, Schuch G, Bitzer M, Heinemann V, Angermeier S, Bolling C, Loose M, Junge S, Pauligk C, Al-Batran SE. First-line modified FOLFOX plus/minus nivolumab and Ipilimumab or FLOT plus nivolumab in advanced gastroesophageal adenocarcinoma: a phase II multi-cohort trial. Nat Commun. 2026 Feb 27;17(1):2072. doi: 10.1038/s41467-026-69622-7.

Drugs

Indications