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Ongoing important trials

KEYNOTE-585 — perioperative pembrolizumab + chemotherapy (gastric/GEJ)

Pembrolizumab Plus Chemotherapy Versus Placebo Plus Chemotherapy for Gastric/GEJ Adenocarcinoma: KEYNOTE-585

Phase
Phase III
Recruitment
Completed
Results maturity
Final analysis
Publication
Peer-reviewed
Regulatory approval
No regulatory approval
NCT
NCT03221426
Registry checked
2026-10-29
Editorial update
2026-10-31

Not a treatment recommendation. Experimental or ongoing research does not by itself replace standard care.

For patients

What is being studied? Perioperative immunotherapy plus chemotherapy improved pathologic response in stomach cancer but did not prove clear survival superiority. Clinicians read it alongside other perioperative trials.

What did it show? Pathologic complete response rose (~13% vs ~2%). EFS did not meet the protocol success criterion; OS was not significantly improved. Do not confuse with MATTERHORN.

What is not proven? That perioperative pembrolizumab + chemo is an EFS/OS standard; generalization to all biomarker subgroups; equivalence to MATTERHORN (durvalumab+FLOT).

Is this standard care today? This listing alone does not replace standard care; approval and guideline context require clinician judgment.

For clinicians

Main cohort: pathCR 13.4% vs 2.0%. Median EFS 44.4 vs 25.5 mo (HR 0.81) — protocol success not met; OS 71.8 vs 55.7 mo (HR 0.86, not significant). Read separately from MATTERHORN.

Cancer / population: Gastric / esophageal — Lokal ileri rezeke edilebilir mide / GEJ adenokarsinomu

Intervention: Perioperatif pembrolizumab + kemoterapi

Primary endpoint: pathCR, EFS, OS (ana kohort)

Source-verified summary: pathCR artışı pozitif; EFS/OS protokol anlamında negatif/başarısız — MATTERHORN EFS/OS yararı ile karıştırılmaz.

Limitations: Eşzamanlı perioperatif IO (MATTERHORN) ile çapraz okuma şart; kontrol kolu pCR oranı düşüktür.

Sources

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