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Clinical trial · no report yet · Phase 3
KEYNOTE-590
First-line Esophageal Carcinoma Study With Pembrolizumab Plus Chemo vs. Chemo (MK-3475-590/KEYNOTE-590)
- NCT03189719 ↗
- Completed
- Merck Sharp & Dohme LLC
- Deep
We haven't built an HCP commentary report on KEYNOTE-590 (pembrolizumab in previously untreated advanced or metastatic esophageal cancer) 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-590 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 | |
|---|---|---|
| X threads | 41 | |
| Podcasts | 21 | |
| YouTube | 15 |
The trial
ClinicalTrials.gov- Official title
- A Randomized, Double-Blind, Placebo-Controlled Phase III Clinical Trial of Pembrolizumab (MK-3475) in Combination With Cisplatin and 5-Fluorouracil Versus Placebo in Combination With Cisplatin and 5-Fluorouracil as First-Line Treatment in Subjects With Advanced/Metastatic Esophageal Carcinoma (KEYNOTE-590)
- Phase
- Phase 3
- Status
- Completed
- Conditions
- Esophageal Neoplasms
- Interventions
- Pembrolizumab; Placebo; Cisplatin; 5-FU
- Arms
- Pembrolizumab + SOC · Experimental
- Placebo + SOC · Placebo comparator
- Enrollment
- 749
- Primary outcomes
- Overall Survival (OS) in Participants With Esophageal Squamous Cell Carcinoma (ESCC) Whose Tumors Are Programmed Cell Death-Ligand 1 (PD-L1) Biomarker-Positive (Combined Positive Score [CPS] ≥10)
- OS in Participants With ESCC
- OS in Participants Whose Tumors Are PD-L1 Biomarker-Positive (CPS ≥10)
- OS in All Participants
- Progression-free Survival (PFS) Per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) As Assessed By Investigator in Participants With ESCC
- PFS Per RECIST 1.1 As Assessed By Investigator in Participants Whose Tumors Are PD-L1 Biomarker-Positive (CPS ≥10)
- PFS Per RECIST 1.1 As Assessed By Investigator in All Participants
- Sponsor
- Merck Sharp & Dohme LLC
- Start
- Jul 25, 2017
- Primary completion
- Jul 2, 2020
- Results posted
- Yes
- Registry record
- NCT03189719 · updated Oct 15, 2024
Publications
linked from the registry- Kato K, Kojima T, Hara H, Tsuji A, Yasui H, Muro K, Satoh T, Yatsuzuka N, Sakata T, Han S, Doi T. First-line pembrolizumab plus chemotherapy versus chemotherapy alone for advanced esophageal cancer: 5-year extended follow-up in the Japanese subgroup of KEYNOTE-590. Esophagus. 2026 Jul;23(3):486-500. doi: 10.1007/s10388-026-01200-8. Epub 2026 Apr 28. PubMed 42047965
- Zhang Y, Diez Garcia M, Shah S, Joo S, Valderrama A, Zhang S, Enzinger PC. Analysis of quality-adjusted survival time without symptoms or toxicity for pembrolizumab plus chemotherapy as treatment for previously untreated participants with advanced or metastatic esophageal cancer. Qual Life Res. 2026 Feb 1;35(3):58. doi: 10.1007/s11136-025-04109-4. PubMed 41620988
- Mansoor W, Joo S, Norquist JM, Kato K, Sun JM, Shah MA, Enzinger P, Adenis A, Doi T, Kojima T, Metges JP, Li Z, Kim SB, Cho BC, Sunpaweravong P, Alsina M, Goekkurt E, Suryawanshi S, Shah S, Shen L. Health-related quality-of-life analysis from KEYNOTE-590: pembrolizumab plus chemotherapy versus chemotherapy for advanced esophageal cancer. Oncologist. 2024 Oct 3;29(10):e1324-e1335. doi: 10.1093/oncolo/oyae087. PubMed 38815152
- Kato K, Kojima T, Hara H, Tsuji A, Yasui H, Muro K, Satoh T, Ogata T, Ishihara R, Goto M, Baba H, Nishina T, Han S, Iwakami K, Yatsuzuka N, Doi T. First-line pembrolizumab plus chemotherapy for advanced/metastatic esophageal cancer: 1-year extended follow-up in the Japanese subgroup of the phase 3 KEYNOTE-590 study. Esophagus. 2024 Jul;21(3):306-318. doi: 10.1007/s10388-024-01053-z. Epub 2024 Apr 12. PubMed 38607538
- Zhang Y, Li C, Du K, Pengkhun N, Huang Z, Gong M, Li Y, Liu X, Li L, Wang D, Wang C, Chen F, Li J. Comparative analysis of immune checkpoint inhibitors in first-line treatment of esophageal squamous cell carcinoma: a network meta-analysis. Immunotherapy. 2023 Jul;15(10):737-750. doi: 10.2217/imt-2022-0236. Epub 2023 May 4. PubMed 37139963
- Kojima T, Hara H, Tsuji A, Yasui H, Muro K, Satoh T, Ogata T, Ishihara R, Goto M, Baba H, Nishina T, Han S, Sakata T, Yatsuzuka N, Doi T, Kato K. First-line pembrolizumab + chemotherapy in Japanese patients with advanced/metastatic esophageal cancer from KEYNOTE-590. Esophagus. 2022 Oct;19(4):683-692. doi: 10.1007/s10388-022-00920-x. Epub 2022 Jun 7. PubMed 35668304
- Zhu Y, Liu K, Ding D, Zhou Y, Peng L. Pembrolizumab Plus Chemotherapy as First-Line Treatment for Advanced Esophageal Cancer: A Cost-Effectiveness Analysis. Adv Ther. 2022 Jun;39(6):2614-2629. doi: 10.1007/s12325-022-02101-9. Epub 2022 Apr 8. PubMed 35394255
- Sun JM, Shen L, Shah MA, Enzinger P, Adenis A, Doi T, Kojima T, Metges JP, Li Z, Kim SB, Cho BC, Mansoor W, Li SH, Sunpaweravong P, Maqueda MA, Goekkurt E, Hara H, Antunes L, Fountzilas C, Tsuji A, Oliden VC, Liu Q, Shah S, Bhagia P, Kato K; KEYNOTE-590 Investigators. Pembrolizumab plus chemotherapy versus chemotherapy alone for first-line treatment of advanced oesophageal cancer (KEYNOTE-590): a randomised, placebo-controlled, phase 3 study. Lancet. 2021 Aug 28;398(10302):759-771. doi: 10.1016/S0140-6736(21)01234-4. PubMed 34454674
- Kato K, Shah MA, Enzinger P, Bennouna J, Shen L, Adenis A, Sun JM, Cho BC, Ozguroglu M, Kojima T, Kostorov V, Hierro C, Zhu Y, McLean LA, Shah S, Doi T. KEYNOTE-590: Phase III study of first-line chemotherapy with or without pembrolizumab for advanced esophageal cancer. Future Oncol. 2019 Apr;15(10):1057-1066. doi: 10.2217/fon-2018-0609. Epub 2019 Feb 8. PubMed 30735435