Phase
Condition
Adenocarcinoma
Gastric Cancer
Treatment
5-fluorouracil
Capecitabine
Placebo
Clinical Study ID
Ages > 18 All Genders
Study Summary
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
Study Description
Connect with a study center
Afflilated Hospital of Bengbu Medical College-Surgical Oncology (Site 0638)
Bengbu, Anhui 233004
ChinaSite Not Available
Beijing Cancer Hospital ( Site 0221)
Beijing, Beijing 100142
ChinaSite Not Available
Beijing Friendship Hospital ( Site 0637)
Beijing, Beijing 100050
ChinaSite Not Available
Fujian Provincial Cancer Hospital ( Site 0230)
Fuzhou, Fujian 350014
ChinaSite Not Available
Fujian Medical University Union Hospital-1 Bingfanglou-Gastric Surgery Department (Site 0632)
Fuzhou Fujian, Fujian 350001
ChinaSite Not Available
The First Affiliated Hospital of Guangzhou Medical University ( Site 0224)
Guangzhou, Guangdong 510120
ChinaSite Not Available
The First Affiliated Hospital, Sun Yat-sen University (Site 0635)
Guangzhou, Guangdong 510080
ChinaSite Not Available
Fourth Hospital of Hebei Medical University ( Site 0633)
Shijiazhuang, Hebei 050035
ChinaSite Not Available
Henan Cancer Hospital (Site 0227)
Zhengzhou, Henan 450008
ChinaSite Not Available
The Affiliated Hospital of Xuzhou Medical College-Oncology ( Site 0645)
Xuzhou, Jiangsu 221006
ChinaSite Not Available
The First Hospital of Jilin University-Gastrointestinal Surgery ( Site 0234)
Changchun, Jilin 130021
ChinaSite Not Available
Tangdu Hospital of Fourth Military Medical University of Chinese People's Liberation Army ( Site 0647)
Xi'an, Shaanxi 710038
ChinaSite Not Available
Shandong Provincial Hospital-Gastrointestinal Surgery ( Site 0640)
Jinan, Shandong 250001
ChinaSite Not Available
The Affiliated Hospital of Qingdao University ( Site 0636)
Qingdao, Shandong 266003
ChinaSite Not Available
Renji Hospital Shanghai Jiao Tong University School of Medicine ( Site 0642)
Shanghai, Shanghai 200127
ChinaSite Not Available
Sichuan Cancer hospital
Chengdu, Sichuan 610041
ChinaSite Not Available
Sir Run Run Shaw Hospital ( Site 0233)
Hangzhou, Zhejiang 430030
ChinaSite Not Available
Zhejiang Cancer Hospital ( Site 0231)
Hangzhou, Zhejiang 310022
ChinaSite Not Available
Zhejiang Provincial People's Hospital-Oncology (Site 0656)
Hangzhou, Zhejiang 310014
ChinaSite Not Available
The First Affiliated Hospital of Wenzhou Medical University (Site 0652)
Wenzhou, Zhejiang 32500
ChinaSite Not Available
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