KEYNOTE-811
Pembrolizumab/Placebo Plus Trastuzumab Plus Chemotherapy in Human Epidermal Growth Factor Receptor 2 Positive (HER2+) Advanced Gastric or Gastroesophageal Junction (GEJ) Adenocarcinoma (MK-3475-811/KEYNOTE-811)
- NCT03615326 ↗
- Completed
- Merck Sharp & Dohme LLC
- Deep
We haven't built an HCP commentary report on KEYNOTE-811 (pembrolizumab plus trastuzumab in first-line HER2-positive 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.
Questions raised in the commentary
Automated from the 40 newest of 292 indexed sources (May 2026 – Nov 2026). Each question is raised in at least two. Not an Erudio report: no source links. Not medical advice.
- Whether KEYNOTE-811 remains an appropriate option alongside newer first-line regimens
- How to interpret comparisons between KEYNOTE-811 and zanidatamab regimens without direct comparative evidence
- Whether PD-L1 expression identifies patients who benefit from pembrolizumab
Also discussed: biomarker testing access.
Indexed commentary on KEYNOTE-811 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 | |
|---|---|---|
| YouTube | 117 | |
| Podcasts | 99 | |
| X threads | 73 | |
| X videos | 3 |
The trial
ClinicalTrials.gov- Official title
- 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
- Phase 3
- Status
- Completed
- Conditions
- Gastric Neoplasms; Gastroesophageal Junction Adenocarcinoma
- Interventions
- Pembrolizumab; Placebo; Cisplatin; 5-FU; Oxaliplatin; Capecitabine; S-1; Trastuzumab
- Arms
- Global Pembrolizumab + Standard of Care First Course · Experimental
- Global Standard of Care · Active comparator
- Japan Pembrolizumab + Trastuzumab + S-1 Plus Oxaliplatin · Experimental
- Japan Trastuzumab + S-1 Plus Oxaliplatin · Experimental
- Enrollment
- 738
- Primary outcomes
- Progression Free Survival (PFS) Per RECIST 1.1 Assessed by BICR
- Overall Survival (OS)
- Sponsor
- Merck Sharp & Dohme LLC
- Start
- Oct 5, 2018
- Primary completion
- Mar 20, 2024
- Results posted
- Yes
- Registry record
- NCT03615326 · updated Aug 26, 2026
Publications
linked from the registry- Janjigian YY, Kawazoe A, Bai Y, Xu J, Lonardi S, Metges JP, Yanez P, Wyrwicz LS, Shen L, Ostapenko Y, Bilici M, Chung HC, Shitara K, Qin SK, Van Cutsem E, Tabernero J, Li K, Shih CS, Bhagia P, Rha SY; KEYNOTE-811 Investigators. Pembrolizumab plus trastuzumab and chemotherapy for HER2-positive gastric or gastro-oesophageal junction adenocarcinoma: interim analyses from the phase 3 KEYNOTE-811 randomised placebo-controlled trial. Lancet. 2023 Dec 9;402(10418):2197-2208. doi: 10.1016/S0140-6736(23)02033-0. Epub 2023 Oct 20. PubMed 37871604
- Janjigian YY, Kawazoe A, Bai Y, Xu J, Lonardi S, Metges JP, Yanez P, Wyrwicz LS, Shen L, Ostapenko Y, Bilici M, Chung HC, Shitara K, Qin S, Van Cutsem E, Tabernero J, Luo S, Mahave M, Tang Y, Lowery M, Monteiro MMF, Xu L, Shih CS, Sharan KP, Bhagia P, Rha SY. Pembrolizumab in HER2-Positive Gastric Cancer. N Engl J Med. 2024 Oct 10;391(14):1360-1362. doi: 10.1056/NEJMc2408121. Epub 2024 Sep 14. No abstract available. PubMed 39282917
- Janjigian YY, Kawazoe A, Yanez P, Li N, Lonardi S, Kolesnik O, Barajas O, Bai Y, Shen L, Tang Y, Wyrwicz LS, Xu J, Shitara K, Qin S, Van Cutsem E, Tabernero J, Li L, Shah S, Bhagia P, Chung HC. The KEYNOTE-811 trial of dual PD-1 and HER2 blockade in HER2-positive gastric cancer. Nature. 2021 Dec;600(7890):727-730. doi: 10.1038/s41586-021-04161-3. Epub 2021 Dec 15. PubMed 34912120
- Chung HC, Bang YJ, S Fuchs C, Qin SK, Satoh T, Shitara K, Tabernero J, Van Cutsem E, Alsina M, Cao ZA, Lu J, Bhagia P, Shih CS, Janjigian YY. First-line pembrolizumab/placebo plus trastuzumab and chemotherapy in HER2-positive advanced gastric cancer: KEYNOTE-811. Future Oncol. 2021 Feb;17(5):491-501. doi: 10.2217/fon-2020-0737. Epub 2020 Nov 10. PubMed 33167735