Pembrolizumab (MK-3475) Plus Chemotherapy Versus Placebo Plus Chemotherapy in Participants Gastric or Gastroesophageal Junction (GEJ) Adenocarcinoma (MK-3475-859/KEYNOTE-859)-China Extension
NCT ID: NCT04859582
Last Updated: 2021-12-16
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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WITHDRAWN
PHASE3
INTERVENTIONAL
2018-11-08
2024-11-29
Brief Summary
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The primary hypotheses of this study are that pembrolizumab plus chemotherapy is superior to placebo plus chemotherapy in terms of overall survival (OS).
Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Pembrolizumab + FP or CAPOX
Participants receive pembrolizumab 200 mg intravenously (IV) on Day 1 of each 21-day cycle (Q3W) for up to 35 cycles (approximately 2 years) + physicians' choice of either cisplatin 80 mg/m\^2 IV on Day 1 Q3W and 5-fluorouracil (5FU) 800 mg/m\^2/day via continuous IV infusion on Days 1 to 5 Q3W OR oxaliplatin 130 mg/m\^2 IV on Day 1 Q3W + capecitabine 1000 mg/m\^2 orally twice a day (BID) on Days 1 to 14 Q3W. Participants who complete 35 administrations or achieve a complete response (CR) but progress after discontinuation can initiate a second course of pembrolizumab for up to 17 cycles (approximately 1 additional year).
Pembrolizumab
Administered as an IV infusion on Day 1 Q3W
Cisplatin
Administered as an IV infusion on Day 1 Q3W
5-fluorouracil
Administered as a continuous IV infusion on Days 1-5 Q3W
Oxaliplatin
Administered as an IV infusion on Day 1 Q3W
Capecitabine
Administered orally BID on Days 1 to 14 Q3W
Placebo + FP or CAPOX
Participants receive placebo for pembrolizumab IV on Day 1 Q3W for up to 35 cycles (approximately 2 years) + physicians' choice of either cisplatin 80 mg/m\^2 IV on Day 1 Q3W and 5FU 800 mg/m\^2/day via continuous IV infusion on Days 1 to 5 Q3W OR oxaliplatin 130 mg/m\^2 IV on Day 1 Q3W + capecitabine 1000 mg/m\^2 orally BID on Days 1 to 14 Q3W.
Cisplatin
Administered as an IV infusion on Day 1 Q3W
5-fluorouracil
Administered as a continuous IV infusion on Days 1-5 Q3W
Oxaliplatin
Administered as an IV infusion on Day 1 Q3W
Capecitabine
Administered orally BID on Days 1 to 14 Q3W
Placebo for Pembrolizumab
Administered as an IV infusion on Day 1 Q3W
Interventions
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Pembrolizumab
Administered as an IV infusion on Day 1 Q3W
Cisplatin
Administered as an IV infusion on Day 1 Q3W
5-fluorouracil
Administered as a continuous IV infusion on Days 1-5 Q3W
Oxaliplatin
Administered as an IV infusion on Day 1 Q3W
Capecitabine
Administered orally BID on Days 1 to 14 Q3W
Placebo for Pembrolizumab
Administered as an IV infusion on Day 1 Q3W
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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 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
18 Years
ALL
No
Sponsors
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Merck Sharp & Dohme LLC
INDUSTRY
Responsible Party
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Principal Investigators
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Medical Director
Role: STUDY_DIRECTOR
Merck Sharp & Dohme LLC
Locations
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Cancer Hospital Chinese Academy of Medical Sciences ( Site 2421)
Beijing, Beijing Municipality, China
Peking Union Medical College Hospital ( Site 2425)
Beijing, Beijing Municipality, China
Fujian Medical University Union Hospital ( Site 2410)
Fuzhou, Fujian, China
Fujian Provincial Cancer Hospital ( Site 2414)
Fuzhou, Fujian, China
900 Hospital of the Joint ( Site 2418)
Fuzhou, Fujian, China
The First Affiliated Hospital of Xiamen University ( Site 2430)
Xiamen, Fujian, China
Zhongshan Hospital Xiamen University ( Site 2447)
Xiamen, Fujian, China
Guangdong General Hospital ( Site 2431)
Guangzhou, Guangdong, China
Peking University Shenzhen Hospital ( Site 2442)
Shenzhen, Guangdong, China
Harbin Medical University Cancer Hospital ( Site 2401)
Harbin, Heilongjiang, China
Henan Cancer Hospital ( Site 2415)
Zhengzhou, Henan, China
Hubei Cancer Hospital ( Site 2434)
Wuhan, Hubei, China
Xiangya Hospital Central-South University ( Site 2419)
Changsha, Hunan, China
Hunan Cancer Hospital ( Site 2439)
Changsha, Hunan, China
Changzhou Cancer Hospital-Changzhou Fourth Peoples Hospital ( Site 2441)
Changzhou, Jiangsu, China
The 81st Hospital of PLA ( Site 2413)
Nanjing, Jiangsu, China
Jiangsu Cancer Hospital ( Site 2432)
Nanjing, Jiangsu, China
Yancheng First People s Hospital ( Site 2426)
Yancheng, Jiangsu, China
The First Affiliated Hospital of Nanchang University ( Site 2440)
Nanchang, Jiangxi, China
The First Hospital of Jilin University ( Site 2416)
Changchun, Jilin, China
The Affiliated Hospital of Qingdao University ( Site 2405)
Qingdao, Shandong, China
Shanghai East Hospital ( Site 2403)
Shanghai, Shanghai Municipality, China
Zhongshan Hospital affiliated to Fudan University ( Site 2407)
Shanghai, Shanghai Municipality, China
1st Affil hosp of Med College of Xi'an Jiaotong University ( Site 2428)
XiAn, Shanxi, China
Cancer Hospital Affiliated to Xinjiang Medical University ( Site 2420)
Ürümqi, Xinjiang, China
Zhejiang Provincial People's Hospital ( Site 2446)
Hangzhou, Zhejiang, China
Sir Run Run Show Hospital ( Site 2427)
Hangzhou, Zhejiang, China
Zhejiang Cancer Hospital ( Site 2417)
Hangzhou, Zhejiang, China
Countries
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Related Links
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Merck Oncology Clinical Trials Information
Other Identifiers
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2018-001757-27
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
MK-3475-859 China Extension
Identifier Type: OTHER
Identifier Source: secondary_id
KEYNOTE-859
Identifier Type: OTHER
Identifier Source: secondary_id
194649
Identifier Type: REGISTRY
Identifier Source: secondary_id
3475-859 China Extension
Identifier Type: -
Identifier Source: org_study_id