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

Last updated: February 19, 2025
Sponsor: Merck Sharp & Dohme LLC
Overall Status: Active - Not Recruiting

Phase

3

Condition

Adenocarcinoma

Gastric Cancer

Treatment

5-fluorouracil

Capecitabine

Placebo

Clinical Study ID

NCT04882241
3475-585 China Extension
173786
PHRR200226-002534
KEYNOTE-585
MK-3475-585
  • Ages > 18
  • All Genders

Study Summary

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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Has previously untreated localized gastric or gastroesophageal junction (GEJ)adenocarcinoma as defined by T3 or greater primary lesion or the presence of anypositive nodes - N+ (clinical nodes) without evidence of metastatic disease.

  • Plans to proceed to surgery following pre-operative chemotherapy based on standardstaging 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 1within 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 ofcontraception for the course of the study through 180 days after the last dose ofchemotherapy.

  • Female participants of childbearing potential must be willing to use an adequatemethod of contraception for the course of the study through 180 days after the lastdose of chemotherapy or through 120 days after the last dose of pembrolizumab,whichever is greater.

  • Has life expectancy of greater than 6 months.

Exclusion

Exclusion Criteria:

  • Has a history of (non-infectious) pneumonitis that required steroids or has currentpneumonitis.

  • Has an active infection requiring systemic therapy.

  • Is currently participating in or has participated in a trial of an investigationalagent or has used an investigational device within 4 weeks prior to the first doseof 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 anagent directed to another stimulatory or co-inhibitory T-cell receptor (i.e.,cytotoxic T-lymphocyte-associated protein 4 [CTLA-4], tumor necrosis factor receptorsuperfamily member 4 [OX-40], necrosis factor receptor superfamily member 9 [CD137])or has previously participated in a Merck pembrolizumab (MK-3475) clinical trial.

  • Has received prior systemic anti-cancer therapy including investigational agents forthe 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 ofimmunosuppressive therapy within 14 days prior the first dose of study treatment.

  • Has a known additional malignancy that is progressing or has required activetreatment within the past 5 years. Note: Participants with basal cell carcinoma ofthe skin, squamous cell carcinoma of the skin, or carcinoma in situ that haveundergone potentially curative therapy are not excluded.

  • Has a known severe hypersensitivity (≥ Grade 3) to pembrolizumab, its activesubstance and/or any of its excipients, or to any of the study chemotherapy agentsand/or to any of their excipients.

  • Has an active autoimmune disease that has required systemic treatment in past 2years.

  • 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 conceivechildren within the projected duration of the study, starting with the screeningvisit through180 days after the last dose of chemotherapy or through 120 days afterthe last dose of pembrolizumab, whichever is greater.

  • Male participants who are expecting to father children within the projected durationof the study, starting with the screening visit through 180 days after the last doseof chemotherapy.

  • Has had an allogenic tissue/solid organ transplant.

  • Has received a live vaccine within 30 days prior to the first dose of studytreatment.

Study Design

Total Participants: 120
Treatment Group(s): 8
Primary Treatment: 5-fluorouracil
Phase: 3
Study Start date:
July 29, 2020
Estimated Completion Date:
April 23, 2025

Study Description

The China extension study will include participants previously enrolled in China in the global study for MK-3475-585 (NCT03221426) plus those enrolled during the China extension enrollment period. A total of approximately 120 Chinese participants will be enrolled.

Connect with a study center

  • Afflilated Hospital of Bengbu Medical College-Surgical Oncology (Site 0638)

    Bengbu, Anhui 233004
    China

    Site Not Available

  • Beijing Cancer Hospital ( Site 0221)

    Beijing, Beijing 100142
    China

    Site Not Available

  • Beijing Friendship Hospital ( Site 0637)

    Beijing, Beijing 100050
    China

    Site Not Available

  • Fujian Provincial Cancer Hospital ( Site 0230)

    Fuzhou, Fujian 350014
    China

    Site Not Available

  • Fujian Medical University Union Hospital-1 Bingfanglou-Gastric Surgery Department (Site 0632)

    Fuzhou Fujian, Fujian 350001
    China

    Site Not Available

  • The First Affiliated Hospital of Guangzhou Medical University ( Site 0224)

    Guangzhou, Guangdong 510120
    China

    Site Not Available

  • The First Affiliated Hospital, Sun Yat-sen University (Site 0635)

    Guangzhou, Guangdong 510080
    China

    Site Not Available

  • Fourth Hospital of Hebei Medical University ( Site 0633)

    Shijiazhuang, Hebei 050035
    China

    Site Not Available

  • Henan Cancer Hospital (Site 0227)

    Zhengzhou, Henan 450008
    China

    Site Not Available

  • The Affiliated Hospital of Xuzhou Medical College-Oncology ( Site 0645)

    Xuzhou, Jiangsu 221006
    China

    Site Not Available

  • The First Hospital of Jilin University-Gastrointestinal Surgery ( Site 0234)

    Changchun, Jilin 130021
    China

    Site Not Available

  • Tangdu Hospital of Fourth Military Medical University of Chinese People's Liberation Army ( Site 0647)

    Xi'an, Shaanxi 710038
    China

    Site Not Available

  • Shandong Provincial Hospital-Gastrointestinal Surgery ( Site 0640)

    Jinan, Shandong 250001
    China

    Site Not Available

  • The Affiliated Hospital of Qingdao University ( Site 0636)

    Qingdao, Shandong 266003
    China

    Site Not Available

  • Renji Hospital Shanghai Jiao Tong University School of Medicine ( Site 0642)

    Shanghai, Shanghai 200127
    China

    Site Not Available

  • Sichuan Cancer hospital

    Chengdu, Sichuan 610041
    China

    Site Not Available

  • Sir Run Run Shaw Hospital ( Site 0233)

    Hangzhou, Zhejiang 430030
    China

    Site Not Available

  • Zhejiang Cancer Hospital ( Site 0231)

    Hangzhou, Zhejiang 310022
    China

    Site Not Available

  • Zhejiang Provincial People's Hospital-Oncology (Site 0656)

    Hangzhou, Zhejiang 310014
    China

    Site Not Available

  • The First Affiliated Hospital of Wenzhou Medical University (Site 0652)

    Wenzhou, Zhejiang 32500
    China

    Site Not Available

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