Phase
Condition
Stomach Cancer
Gastric Cancer
Adenocarcinoma
Treatment
N/AClinical Study ID
Ages > 18 All Genders
Study Summary
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 Description
Connect with a study center
Cancer Hospital Chinese Academy of Medical Sciences ( Site 2421)
Beijing, Beijing 100021
ChinaSite Not Available
Peking Union Medical College Hospital ( Site 2425)
Beijing, Beijing 100730
ChinaSite Not Available
900 Hospital of the Joint ( Site 2418)
Fuzhou, Fujian 350025
ChinaSite Not Available
Fujian Medical University Union Hospital ( Site 2410)
Fuzhou, Fujian 350001
ChinaSite Not Available
Fujian Provincial Cancer Hospital ( Site 2414)
Fuzhou, Fujian 350014
ChinaSite Not Available
The First Affiliated Hospital of Xiamen University ( Site 2430)
Xiamen, Fujian 361003
ChinaSite Not Available
Zhongshan Hospital Xiamen University ( Site 2447)
Xiamen, Fujian 361004
ChinaSite Not Available
Guangdong General Hospital ( Site 2431)
Guangzhou, Guangdong 510080
ChinaSite Not Available
Peking University Shenzhen Hospital ( Site 2442)
Shenzhen, Guangdong 518036
ChinaSite Not Available
Harbin Medical University Cancer Hospital ( Site 2401)
Harbin, Heilongjiang 150081
ChinaSite Not Available
Henan Cancer Hospital ( Site 2415)
Zhengzhou, Henan 450008
ChinaSite Not Available
Hubei Cancer Hospital ( Site 2434)
Wuhan, Hubei 430079
ChinaSite Not Available
Hunan Cancer Hospital ( Site 2439)
Changsha, Hunan 410013
ChinaSite Not Available
Xiangya Hospital Central-South University ( Site 2419)
Changsha, Hunan 410008
ChinaSite Not Available
Changzhou Cancer Hospital-Changzhou Fourth Peoples Hospital ( Site 2441)
Changzhou, Jiangsu 213032
ChinaSite Not Available
Jiangsu Cancer Hospital ( Site 2432)
Nanjing, Jiangsu 210009
ChinaSite Not Available
The 81st Hospital of PLA ( Site 2413)
Nanjing, Jiangsu 210002
ChinaSite Not Available
Yancheng First People s Hospital ( Site 2426)
Yancheng, Jiangsu 224000
ChinaSite Not Available
The First Affiliated Hospital of Nanchang University ( Site 2440)
Nanchang, Jiangxi 330006
ChinaSite Not Available
The First Hospital of Jilin University ( Site 2416)
Chang chun, Jilin 130021
ChinaSite Not Available
The Affiliated Hospital of Qingdao University ( Site 2405)
Qingdao, Shandong 266061
ChinaSite Not Available
Shanghai East Hospital ( Site 2403)
Shanghai, Shanghai 200120
ChinaSite Not Available
Zhongshan Hospital affiliated to Fudan University ( Site 2407)
Shanghai, Shanghai 210000
ChinaSite Not Available
1st Affil hosp of Med College of Xi'an Jiaotong University ( Site 2428)
XiAn, Shanxi 710061
ChinaSite Not Available
Cancer Hospital Affiliated to Xinjiang Medical University ( Site 2420)
Urumqi, Xinjiang 830001
ChinaSite Not Available
Sir Run Run Show Hospital ( Site 2427)
Hangzhou, Zhejiang 310016
ChinaSite Not Available
Zhejiang Cancer Hospital ( Site 2417)
Hangzhou, Zhejiang 310022
ChinaSite Not Available
Zhejiang Provincial People's Hospital ( Site 2446)
Hangzhou, Zhejiang 310014
ChinaSite Not Available
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