Trial Profile
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)
Status:
Active, no longer recruiting
Phase of Trial:
Phase III
Latest Information Update: 18 Apr 2024
Price :
$35
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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 Corp.
- 12 Feb 2024 According to a Merck & Co media release, Health Canada has granted approval of KEYTRUDA (pembrolizumab), Merck's anti-PD-1 therapy, in combination with trastuzumab, fluoropyrimidine- and platinum-containing chemotherapy, for the first-line treatment of adult patients with locally advanced unresectable or metastatic HER2 positive gastric or gastroesophageal junction (GEJ) adenocarcinoma whose tumours express PD-L1 as determined by a validated test.
- 12 Feb 2024 Results published in a Merck & Co Media Release
- 20 Jan 2024 Results assessing exploratory HRQOL outcomes, presented at the 2024 Gastrointestinal Cancers Symposium.