Pembrolizumab (MK-3475) Plus Chemotherapy Versus Placebo Plus Chemotherapy in Participants Gastric or Gastroesophageal Junction (GEJ) Adenocarcinoma (MK-3475-859/KEYNOTE-859)-China Extension

Last updated: December 15, 2021
Sponsor: Merck Sharp & Dohme Corp.
Overall Status: Trial Not Available

Phase

3

Condition

Stomach Cancer

Gastric Cancer

Adenocarcinoma

Treatment

N/A

Clinical Study ID

NCT04859582
3475-859 China Extension
KEYNOTE-859
MK-3475-859 China Extension
2018-001757-27
194649
  • Ages > 18
  • All Genders

Study Summary

The purpose of this study is to evaluate the efficacy of pembrolizumab (MK-3745) in combination with chemotherapy (Cisplatin combined with 5-Fluorouracil [FP regimen] or oxaliplatin combined with capecitabine [CAPOX regimen]) versus placebo in combination with chemotherapy (FP or CAPOX regimens) in the treatment of human epidermal growth factor receptor 2 (HER2) negative advanced gastric or GEJ adenocarcinoma in adult Chinese participants.

The primary hypotheses of this study are that pembrolizumab plus chemotherapy is superior to placebo plus chemotherapy in terms of overall survival (OS).

Eligibility Criteria

Inclusion

Inclusion Criteria

  • Has histologically or cytologically confirmed diagnosis of locally advanced unresectable or metastatic gastric or gastroesophageal junction (GEJ) adenocarcinoma with known programmed cell death ligand 1 (PD-L1) expression status

  • Has human epidermal growth factor receptor 2 (HER2) negative cancer

  • Male participants must agree to use contraception during the intervention period and for at least 95 days after the last dose of chemotherapy, refrain from donating sperm and be abstinent from heterosexual intercourse as their preferred and usual lifestyle and agree to remain abstinent or must agree to use contraception per study protocol unless confirmed to be azoospermic during this period

  • Female participants who are not pregnant, not breastfeeding, and at least one of the following conditions applies: not a woman of childbearing potential (WOCBP) OR is a WOCBP who agrees to use contraception or be abstinent from heterosexual intercourse as their preferred and usual lifestyle during the treatment period and for at least 180 days after the last dose of chemotherapy or for at least 120 days after the last dose of pembrolizumab, whichever is last, and agrees not to donate eggs to others or freeze/store for her own use for the purpose of reproduction during this period

  • Has measurable disease per Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1) as assessed by investigator assessment

  • Has provided archival tumor tissue sample or newly obtained core or excisional biopsy of a tumor lesion not previously irradiated

  • Has provided tumor tissue sample deemed adequate for PD-L1 biomarker analysis

  • Has provided tumor tissue sample for microsatellite instability (MSI) biomarker analysis

  • Has an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 within 3 days prior to the start of study intervention

  • Has adequate organ function as demonstrated by laboratory testing within 10 days prior to the start of study treatment

Exclusion Criteria

  • Has squamous cell or undifferentiated gastric cancer

  • Has had major surgery, open biopsy, or significant traumatic injury within 28 days prior to randomization, anticipation of the need for major surgery during the course of study intervention, or has not recovered adequately from the toxicity and/or complications from previous surgery

  • Has preexisting peripheral neuropathy >Grade 1

  • Is a WOCBP who has a positive urine pregnancy test within 72 hours prior to randomization or treatment allocation

  • Has had previous therapy for locally advanced, unresectable or metastatic gastric/GEJ cancer. Participants may have received prior neoadjuvant and/or adjuvant therapy as long as it was completed ≥6 months prior to randomization

  • Has received prior therapy with an anti-PD-1, anti-PD-L1 or anti- PD-L2 agent or with an agent directed to another stimulatory or coinhibitory T-cell receptor (e.g., cytotoxic T-lymphocyte-associated protein 4 (CTLA-4), OX- 40, CD137)

  • Has received prior systemic anticancer therapy including investigational agents within 4 weeks prior to randomization or has not recovered from all AEs due to any previous therapies to ≤Grade 1 or baseline

  • Has received prior radiotherapy within 2 weeks prior to study start or has not recovered from all previous radiation-related toxicities, required corticosteroids, and have not had radiation pneumonitis. A 1-week washout is permitted for palliative radiation (≤2 weeks of radiotherapy) to noncentral nervous system (CNS) disease

  • Has received a live or live-attenuated vaccine within 30 days prior to the first dose of study treatment

  • Is currently participating in or has participated in a study of an investigational agent or has used an investigational device within 4 weeks prior to the first dose of study treatment

  • Has a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy or any other form of immunosuppressive therapy within 7 days prior to the first dose of study treatment

  • Has a known additional malignancy that is progressing or has required active treatment within the past 5 years with the exception of basal cell carcinoma of the skin, squamous cell carcinoma of the skin, or carcinoma in situ (eg, breast carcinoma, cervical cancer in situ) that have undergone potentially curative therapy

  • Has known active CNS metastases and/or carcinomatous meningitis

  • Has severe hypersensitivity (≥Grade 3) to pembrolizumab and/or any of its excipients

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

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

  • Has an active infection requiring systemic therapy

  • Has a known history of human immunodeficiency virus (HIV) infection

  • Has a known history of Hepatitis B (defined as Hepatitis B surface antigen [HBsAg] reactive) or known active Hepatitis C virus (defined as Hepatitis C virus [HCV] ribonucleic acid [RNA] detected qualitatively) infection

  • Has a known history of active tuberculosis

  • Has hypokalemia (serum potassium less than the lower limit of normal)

  • Has hypomagnesemia (serum magnesium less than the lower limit of normal)

  • Has hypocalcemia (serum calcium less than the lower limit of normal)

  • Has a history or current evidence of any condition (eg, known deficiency of the enzyme dihydropyrimidine dehydrogenase), therapy, or laboratory abnormality that might confound the results of the study, interfere with the participant's participation for the full duration of the study, or is not in the best interest of the participant to participate, in the opinion of the treating investigator

  • Has a known psychiatric or substance abuse disorder that would interfere with the participant's ability to cooperate with the requirements of the study

  • Is pregnant or breastfeeding or expecting to conceive or father children within the projected duration of the study, starting with the screening visit through 180 days after the last dose of chemotherapy or through 120 days after the last dose of pembrolizumab, whichever is last

  • Has had an allogenic tissue/solid organ transplant

  • Has a known severe hypersensitivity (≥ Grade 3) to any of the study chemotherapy agents (including, but not limited to, infusional 5-fluorouracil or oral capecitabine) and/or to any of their excipients

  • For participants taking cisplatin: has Grade ≥2 audiometric hearing loss

Study Design

Study Start date:
November 08, 2018
Estimated Completion Date:
November 29, 2024

Study Description

The China extension study will include participants previously enrolled in China in the global study for MK-3475-859 (NCT03675737) plus those enrolled during the China extension enrollment period. A total of approximately 231 Chinese participants will be enrolled.

Connect with a study center

  • Cancer Hospital Chinese Academy of Medical Sciences ( Site 2421)

    Beijing, Beijing 100021
    China

    Site Not Available

  • Peking Union Medical College Hospital ( Site 2425)

    Beijing, Beijing 100730
    China

    Site Not Available

  • 900 Hospital of the Joint ( Site 2418)

    Fuzhou, Fujian 350025
    China

    Site Not Available

  • Fujian Medical University Union Hospital ( Site 2410)

    Fuzhou, Fujian 350001
    China

    Site Not Available

  • Fujian Provincial Cancer Hospital ( Site 2414)

    Fuzhou, Fujian 350014
    China

    Site Not Available

  • The First Affiliated Hospital of Xiamen University ( Site 2430)

    Xiamen, Fujian 361003
    China

    Site Not Available

  • Zhongshan Hospital Xiamen University ( Site 2447)

    Xiamen, Fujian 361004
    China

    Site Not Available

  • Guangdong General Hospital ( Site 2431)

    Guangzhou, Guangdong 510080
    China

    Site Not Available

  • Peking University Shenzhen Hospital ( Site 2442)

    Shenzhen, Guangdong 518036
    China

    Site Not Available

  • Harbin Medical University Cancer Hospital ( Site 2401)

    Harbin, Heilongjiang 150081
    China

    Site Not Available

  • Henan Cancer Hospital ( Site 2415)

    Zhengzhou, Henan 450008
    China

    Site Not Available

  • Hubei Cancer Hospital ( Site 2434)

    Wuhan, Hubei 430079
    China

    Site Not Available

  • Hunan Cancer Hospital ( Site 2439)

    Changsha, Hunan 410013
    China

    Site Not Available

  • Xiangya Hospital Central-South University ( Site 2419)

    Changsha, Hunan 410008
    China

    Site Not Available

  • Changzhou Cancer Hospital-Changzhou Fourth Peoples Hospital ( Site 2441)

    Changzhou, Jiangsu 213032
    China

    Site Not Available

  • Jiangsu Cancer Hospital ( Site 2432)

    Nanjing, Jiangsu 210009
    China

    Site Not Available

  • The 81st Hospital of PLA ( Site 2413)

    Nanjing, Jiangsu 210002
    China

    Site Not Available

  • Yancheng First People s Hospital ( Site 2426)

    Yancheng, Jiangsu 224000
    China

    Site Not Available

  • The First Affiliated Hospital of Nanchang University ( Site 2440)

    Nanchang, Jiangxi 330006
    China

    Site Not Available

  • The First Hospital of Jilin University ( Site 2416)

    Chang chun, Jilin 130021
    China

    Site Not Available

  • The Affiliated Hospital of Qingdao University ( Site 2405)

    Qingdao, Shandong 266061
    China

    Site Not Available

  • Shanghai East Hospital ( Site 2403)

    Shanghai, Shanghai 200120
    China

    Site Not Available

  • Zhongshan Hospital affiliated to Fudan University ( Site 2407)

    Shanghai, Shanghai 210000
    China

    Site Not Available

  • 1st Affil hosp of Med College of Xi'an Jiaotong University ( Site 2428)

    XiAn, Shanxi 710061
    China

    Site Not Available

  • Cancer Hospital Affiliated to Xinjiang Medical University ( Site 2420)

    Urumqi, Xinjiang 830001
    China

    Site Not Available

  • Sir Run Run Show Hospital ( Site 2427)

    Hangzhou, Zhejiang 310016
    China

    Site Not Available

  • Zhejiang Cancer Hospital ( Site 2417)

    Hangzhou, Zhejiang 310022
    China

    Site Not Available

  • Zhejiang Provincial People's Hospital ( Site 2446)

    Hangzhou, Zhejiang 310014
    China

    Site Not Available

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