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Clinical trial · no report yet · Phase 3
KEYNOTE-859
Pembrolizumab (MK-3475) Plus Chemotherapy Versus Placebo Plus Chemotherapy in Participants Gastric or Gastroesophageal Junction (GEJ) Adenocarcinoma (MK-3475-859/KEYNOTE-859)
- NCT03675737 ↗
- Completed
- Merck Sharp & Dohme LLC
- Deep
We haven't built an HCP commentary report on KEYNOTE-859 (pembrolizumab in first-line HER2-negative advanced gastric or gastroesophageal junction adenocarcinoma) yet. This page shows the registry record and the public commentary we found that names the trial. A report reads that commentary and sets out what clinicians said about the trial, each point linked to its source. How reports are made.
Indexed commentary on KEYNOTE-859 so far
Podcasts, YouTube videos and X posts we have indexed that name the trial. It is where a report starts, not where it ends: the build searches for more, so finished reports usually cover more than this.
| Channel | Indexed | |
|---|---|---|
| Podcasts | 39 | |
| YouTube | 36 | |
| X threads | 28 |
The trial
ClinicalTrials.gov- Official title
- 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)
- Phase
- Phase 3
- Status
- Completed
- Conditions
- Stomach Neoplasms
- Interventions
- Pembrolizumab; Cisplatin; 5-fluorouracil; oxaliplatin; capecitabine; Placebo for Pembrolizumab
- Arms
- Pembrolizumab + Chemotherapy (FP or CAPOX regimen) · Experimental
- Placebo + Chemotherapy (FP or CAPOX regimen) · Active comparator
- Enrollment
- 1,579
- Primary outcomes
- Overall Survival (OS) in All Participants
- Overall Survival (OS) In Participants With Programmed Cell Death Ligand 1 (PD-L1) Combined Positive Score (CPS) ≥1
- Overall Survival (OS) In Participants With Programmed Cell Death Ligand 1 (PD-L1) Combined Positive Score (CPS) ≥10
- Sponsor
- Merck Sharp & Dohme LLC
- Start
- Nov 8, 2018
- Primary completion
- Oct 3, 2022
- Results posted
- Yes
- Registry record
- NCT03675737 · updated Feb 27, 2026
Publications
linked from the registry- Rha SY, Oh DY, Yanez P, Bai Y, Ryu MH, Lee J, Rivera F, Alves GV, Garrido M, Shiu KK, Fernandez MG, Li J, Lowery MA, Cil T, Cruz FM, Qin S, Luo S, Pan H, Wainberg ZA, Yin L, Bordia S, Bhagia P, Wyrwicz LS; KEYNOTE-859 investigators. Pembrolizumab plus chemotherapy versus placebo plus chemotherapy for HER2-negative advanced gastric cancer (KEYNOTE-859): a multicentre, randomised, double-blind, phase 3 trial. Lancet Oncol. 2023 Nov;24(11):1181-1195. doi: 10.1016/S1470-2045(23)00515-6. Epub 2023 Oct 21. PubMed 37875143
- Qin S, Bai Y, Li J, Pan H, Luo S, Qu Y, Ye F, Yang L, Liu T, Li W, Chen X, Yang J, Ying J, Lin X, Zhao L, Liang X, Mao Y, Guo R, Zuo Y, Bordia S, Li S. First-Line Pembrolizumab Plus Chemotherapy for HER2-Negative Advanced Gastric Cancer: China Subgroup Analysis of the Randomized Phase 3 KEYNOTE-859 Study. Adv Ther. 2025 Apr;42(4):1892-1906. doi: 10.1007/s12325-024-03069-4. Epub 2025 Mar 1. PubMed 40025394
- Wyrwicz L, Kalampoki V, Valderrama A, Young K. Pembrolizumab plus chemotherapy for advanced HER2-negative gastric or gastroesophageal junction cancer: KEYNOTE-859 Q-TWiST analysis. Immunotherapy. 2026 Feb;18(3):161-167. doi: 10.1080/1750743X.2026.2647579. Epub 2026 Apr 11. PubMed 41964430
- Yasui H, Aizawa M, Yamaguchi K, Kawazoe A, Hara H, Tsuda M, Shoji H, Sugimoto N, Shibata N, Amagai K, Choda Y, Iwagami S, Esaki T, Kadowaki S, Shiratori S, Han S, Bordia S, Shitara K. First-line pembrolizumab plus chemotherapy for participants in Japan with gastric or gastroesophageal junction adenocarcinoma: subgroup analysis of the phase 3 KEYNOTE-859 study. Int J Clin Oncol. 2025 Oct;30(10):2003-2011. doi: 10.1007/s10147-025-02847-6. Epub 2025 Aug 1. PubMed 40750941
- Tabernero J, Bang YJ, Van Cutsem E, Fuchs CS, Janjigian YY, Bhagia P, Li K, Adelberg D, Qin SK. KEYNOTE-859: a Phase III study of pembrolizumab plus chemotherapy in gastric/gastroesophageal junction adenocarcinoma. Future Oncol. 2021 Aug;17(22):2847-2855. doi: 10.2217/fon-2021-0176. Epub 2021 May 12. PubMed 33975465