Evaluating Pembrolizumab, Trastuzumab and FLOT as Perioperative Treatment of HER2-positive, Localized Esophagogastric Adenocarcinoma

Summary

The study is an open-label, single arm, multicenter phase II trial investigating the clinical activity of a perioperative therapy consisting of a combination of pembrolizumab, trastuzumab and FLOT, followed by pembrolizumab plus trastuzumab alone for a maximum systemic treatment duration of one year in patients with Her-2 positive localized esophagogastric adenocarcinoma.

Timeline

Start

2023-02-13

Primary completion

2027-10

Completion

2027-12

Publications

• Stein A, Goekkurt E, Al-Batran SE, Moosmann N, Ettrich TJ, Goetze T, Gruen B, Homann N, Lorenzen S, Hofheinz RD, Rempel V, Siegler G, Muller C, Thiele B, Broering T, Cruz MS, Pauligk C, Binder M, Tintelnot J. Perioperative pembrolizumab, trastuzumab and FLOT in HER2-positive localized esophagogastric adenocarcinoma: a phase 2 trial. Nat Med. 2025 Dec;31(12):4197-4204. doi: 10.1038/s41591-025-03979-y. Epub 2025 Oct 18.
• Tintelnot J, Stein A, Al-Batran SE, Ettrich T, Gotze T, Grun B, Haag GM, Heuer V, Hofheinz RD, Homann N, Broring TS, Cruz MS, Kurreck A, Lorenzen S, Moosmann N, Muller C, Schuler M, Siegler G, Binder M, Gokkurt E. Pembrolizumab and trastuzumab in combination with FLOT in the perioperative treatment of HER2-positive, localized esophagogastric adenocarcinoma-a phase II trial of the AIO study group (AIO STO 0321). Front Oncol. 2023 Oct 16;13:1272175. doi: 10.3389/fonc.2023.1272175. eCollection 2023.

Drugs

Indications