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NCT04882241CompletedPhase 3

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)-China Extension

A Phase III, Randomized, Double-Blind, Clinical Trial of Pembrolizumab (MK-3475) Plus Chemotherapy (XP or FP) Versus Placebo Plus Chemotherapy (XP or FP) as Neoadjuvant/Adjuvant Treatment for Subjects With Gastric and Gastroesophageal Junction (GEJ) Adenocarcinoma (KEYNOTE-585)

Source: ClinicalTrials.gov · Last updated 6 Mar 2026

Brief summary (registry, in English)

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 Chinese adults with gastric and gastroesophageal junction (GEJ) adenocarcinoma. No formal hypothesis testing will be done.

Status (registry)
Completed
Phase (registry)
Phase 3
Study type
Interventional
Enrollment
120 (actual)
First submitted
7 May 2021
Start date
29 Jul 2020
Primary completion date
16 Feb 2024
Lead sponsor
Merck Sharp & Dohme LLC
NCT number
NCT04882241

What you commit to

  • Study type: Interventional · Phase 3
  • Participants enrolled: 120
  • From 29 Jul 2020 to the primary completion date, 16 Feb 2024
  • 20 sites in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • 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 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.
  • 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.

Other illness

  • Has a history of (non-infectious) pneumonitis that required steroids or has current pneumonitis.
  • Has an active infection requiring systemic therapy.
  • 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).

Lab values

  • 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.

Who the study is looking for

  • Has previously untreated localized gastric or gastroesophageal junction (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.

Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (20)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Beijing Friendship Hospital ( Site 0637)
Coordinator of this site? Confirm its status
BeijingChinaUnknown status
Beijing Cancer Hospital ( Site 0221)
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BeijingChinaUnknown status
Afflilated Hospital of Bengbu Medical College-Surgical Oncology (Site 0638)
Coordinator of this site? Confirm its status
BengbuChinaUnknown status
The First Hospital of Jilin University-Gastrointestinal Surgery ( Site 0234)
Coordinator of this site? Confirm its status
ChangchunChinaUnknown status
Sichuan Cancer Hospital
Coordinator of this site? Confirm its status
ChengduChinaUnknown status
Fujian Provincial Cancer Hospital ( Site 0230)
Coordinator of this site? Confirm its status
FuzhouChinaUnknown status
Fujian Medical University Union Hospital-1 Bingfanglou-Gastric Surgery Department (Site 0632)
Coordinator of this site? Confirm its status
Fuzhou FujianChinaUnknown status
The First Affiliated Hospital, Sun Yat-sen University (Site 0635)
Coordinator of this site? Confirm its status
GuangzhouChinaUnknown status
The First Affiliated Hospital of Guangzhou Medical University ( Site 0224)
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GuangzhouChinaUnknown status
Sir Run Run Shaw Hospital ( Site 0233)
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HangzhouChinaUnknown status
Zhejiang Cancer Hospital ( Site 0231)
Coordinator of this site? Confirm its status
HangzhouChinaUnknown status
Zhejiang Provincial People's Hospital-Oncology (Site 0656)
Coordinator of this site? Confirm its status
HangzhouChinaUnknown status
Shandong Provincial Hospital-Gastrointestinal Surgery ( Site 0640)
Coordinator of this site? Confirm its status
JinanChinaUnknown status
The Affiliated Hospital of Qingdao University ( Site 0636)
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QingdaoChinaUnknown status
Renji Hospital Shanghai Jiao Tong University School of Medicine ( Site 0642)
Coordinator of this site? Confirm its status
ShanghaiChinaUnknown status
Fourth Hospital of Hebei Medical University ( Site 0633)
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ShijiazhuangChinaUnknown status
The First Affiliated Hospital of Wenzhou Medical University (Site 0652)
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WenzhouChinaUnknown status
Tangdu Hospital of Fourth Military Medical University of Chinese People's Liberation Army ( Site 0647)
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Xi'anChinaUnknown status
The Affiliated Hospital of Xuzhou Medical College-Oncology ( Site 0645)
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XuzhouChinaUnknown status
Henan Cancer Hospital (Site 0227)
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ZhengzhouChinaUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.