Trial Profile
A Phase 3, Randomized, Double-blind Clinical Study of Pembrolizumab (MK-3475) Plus Chemotherapy Versus Placebo Plus Chemotherapy as First-line Treatment in Participants With HER2 Negative, Previously Untreated, Unresectable or Metastatic Gastric Orgastroesophageal Junction Adenocarcinoma (KEYNOTE-859)
Status:
Active, no longer recruiting
Phase of Trial:
Phase III
Latest Information Update: 28 Mar 2024
Price :
$35
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At a glance
- Drugs Pembrolizumab (Primary) ; Capecitabine; Cisplatin; Fluorouracil; Oxaliplatin
- Indications Adenocarcinoma; Gastric cancer; Oesophageal cancer
- Focus Registrational; Therapeutic Use
- Acronyms KEYNOTE-859; MK-3475-859/KEYNOTE-859
- Sponsors Merck Sharp & Dohme Corp.
- 20 Jan 2024 Results of post hoc, exploratory analysis assessing the efficacy of 1L pembro + chemo in the GEJC and EAC subgroups of KEYNOTE-590 and the GEJ subgroup of KEYNOTE-859 presented at the 2024 Gastrointestinal Cancers Symposium.
- 18 Dec 2023 According to a Merck & Co media release, approvals allow marketing of these KEYTRUDA regimens for these indications in all 27 EU member states, as well as Iceland, Liechtenstein, Norway and Northern Ireland. With these decisions, KEYTRUDA is now approved for 26 indications in the EU, including seven in gastrointestinal cancers.
- 18 Dec 2023 According to a Merck & Co media release, company announced European Commission (EC) has approved in gastrointestinal cancers based on data from this study.