Study of Pembrolizumab (MK-3475) Plus Chemotherapy Versus Placebo Plus Chemotherapy in Participants With Gastric or Gastroesophageal Junction (GEJ) Adenocarcinoma (MK-3475-585/KEYNOTE-585)

Completed · Phase 3 · Has a placebo group

Conditions studied: Gastric Cancer, Gastroesophageal Junction Cancer

In brief

The purpose of this study is to evaluate the efficacy of pembrolizumab (MK-3745) in the neoadjuvant (prior to surgery) or adjuvant (after surgery) treatment of previously untreated adults with gastric and gastroesophageal junction (GEJ) adenocarcinoma. The primary study hypotheses are that: * Neoadjuvant and adjuvant pembrolizumab plus chemotherapy, followed by adjuvant pembrolizumab is superior to neoadjuvant and adjuvant placebo plus chemotherapy, followed by adjuvant placebo in terms of Event-free Survival (EFS) based on Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1), and * Neoadjuvant pembrolizumab plus chemotherapy is superior to neoadjuvant placebo plus chemotherapy in terms of rate of Pathological Complete Response (pathCR) at the time of surgery. With Amendment 10, upon study completion, participants will be discontinued and may be enrolled in an extension study.

Key facts

Study ID: NCT03221426
Run by: Merck Sharp & Dohme LLC
People needed: 1007
Starts: 2017-10-09
Expected to finish: 2025-04-23
Last updated by the study team: 2026-03-09

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

Has previously untreated localized gastric or GEJ adenocarcinoma as defined by T3 or greater primary lesion or the presence of any positive nodes - N+ (clinical nodes) without evidence of metastatic disease.
Plans to proceed to surgery following pre-operative chemotherapy based on standard staging studies per local practice.
Is willing to provide tissue from a tumor lesion at baseline and at time of surgery.
Has an Eastern Cooperative Oncology Group (ECOG) performance status score of 0 to 1 within 3 days prior to the first dose of study treatment.
Has adequate organ function.
Male participants of childbearing potential must agree to use an adequate method of contraception for the course of the study through 180 days after the last dose of chemotherapy.
Female participants of childbearing potential must be willing to use an adequate method of contraception for the course of the study through 180 days after the last dose of chemotherapy or through 120 days after the last dose of pembrolizumab, whichever is greater.
Has life expectancy of greater than 6 months.

You may not qualify if…

Has a history of (non-infectious) pneumonitis that required steroids or has current pneumonitis.
Has an active infection requiring systemic therapy.
Is currently participating in or has participated in a trial of an investigational agent or has used an investigational device within 4 weeks prior to the first dose of study treatment.
Has received prior therapy with an anti-programmed cell death protein-1 (anti-PD-1), anti-programmed cell death-ligand 1 (anti-PD-L1), or anti-PD-L2 agent or with an agent directed to another stimulatory or co-inhibitory T-cell receptor (i.e., cytotoxic T-lymphocyte-associated protein 4 [CTLA-4], tumor necrosis factor receptor superfamily member 4 [OX-40], necrosis factor receptor superfamily member 9 [CD137]) or has previously participated in a MSD pembrolizumab (MK-3475) clinical study.
Has received prior systemic anti-cancer therapy including investigational agents for the current malignancy.
Has a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy (in dosing exceeding 10 mg daily of prednisone equivalent) or any other form of immunosuppressive therapy within 14 days prior the first dose of study treatment.
Has a known additional malignancy that is progressing or has required active treatment within the past 5 years. Note: Participants with basal cell carcinoma of the skin, squamous cell carcinoma of the skin, or carcinoma in situ that have undergone potentially curative therapy are not excluded.
Has a known severe hypersensitivity (≥ Grade 3) to pembrolizumab, its active substance and/or any of its excipients, or to any of the study chemotherapy agents and/or to any of their excipients.
Has an active autoimmune disease that has required systemic treatment in past 2 years.
Has a known history of human immunodeficiency virus (HIV) infection.
Has a known history of Hepatitis B or known active Hepatitis C virus infection.
Has a known history of active tuberculosis (TB).
Female participants who are pregnant or breastfeeding or expecting to conceive children within the projected duration of the study, starting with the screening visit through180 days after the last dose of chemotherapy or through 120 days after the last dose of pembrolizumab, whichever is greater.
Male participants who are expecting to father children within the projected duration of the study, starting with the screening visit through 180 days after the last dose of chemotherapy.
Has had an allogenic tissue/solid organ transplant.
Has received a live vaccine within 30 days prior to the first dose of study treatment.

Where it is running

Yale Cancer Center ( Site 0016) — New Haven, Connecticut, United States
Georgetown University ( Site 0015) — Washington D.C., District of Columbia, United States
Northwestern University - Robert H. Lurie Comprehensive Cancer Center ( Site 0018) — Chicago, Illinois, United States
The University of Chicago Medical Center ( Site 0004) — Chicago, Illinois, United States
Roswell Park Cancer Institute ( Site 0001) — Buffalo, New York, United States
Laura and Isaac Perlmutter Cancer Center at NYU Langone Health ( Site 0019) — New York, New York, United States
Memorial Sloan Kettering ( Site 0024) — New York, New York, United States
Weill Cornell Medical Center ( Site 0023) — New York, New York, United States
University of Rochester ( Site 0011) — Rochester, New York, United States
Fox Chase Cancer Center ( Site 0006) — Philadelphia, Pennsylvania, United States
Temple University Hospital ( Site 0026) — Philadelphia, Pennsylvania, United States
University of Utah, Huntsman Cancer Institute ( Site 0012) — Salt Lake City, Utah, United States
Virginia Cancer Specialists, PC ( Site 0010) — Fairfax, Virginia, United States
Institut Jules Bordet ( Site 0480) — Brussels, Bruxelles-Capitale, Region de, Belgium
Hopital Erasme ULB ( Site 0484) — Brussels, Bruxelles-Capitale, Region de, Belgium
UCL Saint Luc ( Site 0479) — Brussels, Bruxelles-Capitale, Region de, Belgium
Grand Hopital de Charleroi ( Site 0478) — Charleroi, Hainaut, Belgium
CHU de Liege ( Site 0482) — Liège, Liege, Belgium
CHU UCL Namur Site de Godinne ( Site 0485) — Yvoir, Namur, Belgium
UZ Gent ( Site 0486) — Ghent, Oost-Vlaanderen, Belgium
UZ Leuven ( Site 0483) — Leuven, Vlaams-Brabant, Belgium
AZ Groeninge ( Site 0481) — Kortrijk, West-Vlaanderen, Belgium
Instituto do Cancer do Ceara ( Site 0311) — Fortaleza, Ceará, Brazil
Uniao Brasileira de Educacao e Assistencia Hospital Sao Lucas da Pucrs ( Site 0308) — Porto Alegre, Rio Grande do Sul, Brazil
City of Hope ( Site 0005) — Duarte, California, United States

Full record on ClinicalTrials.gov

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