A Phase III, Randomized, Double-blind Trial Comparing Trastuzumab Plus Chemotherapy and Pembrolizumab With Trastuzumab Plus Chemotherapy and Placebo as First-line Treatment in Participants With HER2 Positive Advanced Gastric or Gastroesophageal Junction Adenocarcinoma (KEYNOTE 811)
Phase of Trial: Phase III
Latest Information Update: 13 Feb 2019
At a glance
- Drugs Pembrolizumab (Primary) ; Trastuzumab (Primary) ; Capecitabine; Cisplatin; Fluorouracil; Gimeracil/oteracil/tegafur; Oxaliplatin
- Indications Adenocarcinoma; Gastric cancer; Oesophageal cancer
- Focus Registrational; Therapeutic Use
- Acronyms KEYNOTE 811
- Sponsors Merck Sharp & Dohme
- 01 Oct 2018 Planned initiation date (estimated date for recruitment of the first subject) changed from 7 Sep 2018 to 5 Oct 2018.
- 20 Sep 2018 Planned End Date changed from 23 Dec 2023 to 20 Mar 2024.
- 20 Sep 2018 Status changed from not yet recruiting to recruiting.