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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT03675737
Registration number
NCT03675737
Ethics application status
Date submitted
17/09/2018
Date registered
18/09/2018
Date last updated
20/05/2024
Titles & IDs
Public title
Pembrolizumab (MK-3475) Plus Chemotherapy Versus Placebo Plus Chemotherapy in Participants Gastric or Gastroesophageal Junction (GEJ) Adenocarcinoma (MK-3475-859/KEYNOTE-859)
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Scientific title
A Phase 3, Randomized, Double-blind Clinical Study of Pembrolizumab (MK-3475) Plus Chemotherapy Versus Placebo Plus Chemotherapy as First-line Treatment in Participants With HER2 Negative, Previously Untreated, Unresectable or Metastatic Gastric Orgastroesophageal Junction Adenocarcinoma (KEYNOTE-859)
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Secondary ID [1]
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0
MK-3475-859
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Secondary ID [2]
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3475-859
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Stomach Neoplasms
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0
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Condition category
Condition code
Cancer
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0
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Stomach
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Other interventions - Pembrolizumab
Treatment: Drugs - Cisplatin
Treatment: Drugs - 5-fluorouracil
Treatment: Drugs - oxaliplatin
Treatment: Drugs - capecitabine
Treatment: Drugs - Placebo for Pembrolizumab
Experimental: Pembrolizumab + Chemotherapy (FP or CAPOX regimen) - 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 (FP regimen) 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 (CAPOX regimen).
Participants who complete up to 35 administrations of pembrolizumab (approximately 2 years) or achieve a complete response (CR) but experience progression of disease (PD), can initiate a second course of pembrolizumab for up to 17 cycles (approximately 1 additional year).
Active Comparator: Placebo + Chemotherapy (FP or CAPOX regimen) - Participants receive placebo 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 (FP regimen) OR oxaliplatin 130 mg/m^2 IV on Day 1 Q3W + capecitabine 1000 mg/m^2 orally BID on Days 1 to 14 Q3W (CAPOX regimen).
Other interventions: Pembrolizumab
Administered as an IV infusion on Day 1 Q3W
Treatment: Drugs: Cisplatin
Administered as an IV infusion on Day 1 Q3W
Treatment: Drugs: 5-fluorouracil
Administered as a continuous IV infusion on Days 1-5 Q3W
Treatment: Drugs: oxaliplatin
Administered as an IV infusion on Day 1 Q3W
Treatment: Drugs: capecitabine
Administered orally BID on Days 1 to 14 Q3W
Treatment: Drugs: Placebo for Pembrolizumab
Administered as an IV infusion on Day 1 Q3W
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Intervention code [1]
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Other interventions
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Intervention code [2]
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Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Overall Survival (OS) in All Participants
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Assessment method [1]
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OS was defined as the time from randomization to death due to any cause. Participants without documented death at the time of the analysis were censored at the date of the last follow-up. OS was estimated using the product-limit (Kaplan-Meier) method for censored data.
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Timepoint [1]
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Up to 45.9 months
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Primary outcome [2]
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Overall Survival (OS) In Participants With Programmed Cell Death Ligand 1 (PD-L1) Combined Positive Score (CPS) =1
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Assessment method [2]
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OS was defined as the time from randomization to death due to any cause. Participants without documented death at the time of the analysis were censored at the date of the last follow-up. OS was estimated using the product-limit (Kaplan-Meier) method for censored data.
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Timepoint [2]
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Up to 45.9 months
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Primary outcome [3]
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Overall Survival (OS) In Participants With Programmed Cell Death Ligand 1 (PD-L1) Combined Positive Score (CPS) =10
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Assessment method [3]
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OS was defined as the time from randomization to death due to any cause. Participants without documented death at the time of the analysis were censored at the date of the last follow-up. OS was estimated using the product-limit (Kaplan-Meier) method for censored data.
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Timepoint [3]
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Up to 45.9 months
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Secondary outcome [1]
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Progression Free Survival (PFS) Per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) Assessed by Blinded Independent Central Review (BICR) in All Participants
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Assessment method [1]
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PFS was defined as the time from randomization to the first documented progressive disease (PD) or death due to any cause, whichever occurred first. Per RECIST 1.1 as assessed by BICR, PD was defined as =20% increase in the sum of diameters of target lesions. In addition to the relative increase of 20%, the sum must also have demonstrated an absolute increase of =5 mm. The appearance of =1 new lesions was also considered PD. PFS was estimated using the product-limit (Kaplan-Meier) method for censored data.
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Timepoint [1]
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Up to 49.5 months
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Secondary outcome [2]
0
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Progression Free Survival (PFS) Per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) Assessed by Blinded Independent Central Review (BICR) in Participants With Programmed Cell Death Ligand 1 (PD-L1) Combined Positive Score (CPS) =1
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Assessment method [2]
0
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PFS was defined as the time from randomization to the first documented progressive disease (PD) or death due to any cause, whichever occurred first. Per RECIST 1.1 as assessed by BICR, PD was defined as =20% increase in the sum of diameters of target lesions. In addition to the relative increase of 20%, the sum must also have demonstrated an absolute increase of =5 mm. The appearance of =1 new lesions was also considered PD. PFS was estimated using the product-limit (Kaplan-Meier) method for censored data.
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Timepoint [2]
0
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Up to 49.5 months
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Secondary outcome [3]
0
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Progression Free Survival (PFS) Per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) Assessed by Blinded Independent Central Review (BICR) in Participants With Programmed Cell Death Ligand 1 (PD-L1) Combined Positive Score (CPS) =10
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Assessment method [3]
0
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PFS was defined as the time from randomization to the first documented progressive disease (PD) or death due to any cause, whichever occurred first. Per RECIST 1.1 as assessed by BICR, PD was defined as =20% increase in the sum of diameters of target lesions. In addition to the relative increase of 20%, the sum must also have demonstrated an absolute increase of =5 mm. The appearance of =1 new lesions was also considered PD. PFS was estimated using the product-limit (Kaplan-Meier) method for censored data.
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Timepoint [3]
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Up to 49.5 months
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Secondary outcome [4]
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Objective Response Rate (ORR) Per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) Assessed by Blinded Independent Central Review (BICR) in All Participants
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Assessment method [4]
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ORR was defined as the percentage of the participants who had a confirmed Complete Response (CR: disappearance of all target lesions) or Partial Response (PR: =30% decrease in the sum of diameters (SOD) of target lesions, taking as reference the baseline SOD) according to RECIST 1.1 as assessed by BICR.
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Timepoint [4]
0
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Up to 49.5 months
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Secondary outcome [5]
0
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Objective Response Rate (ORR) Per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) Assessed by Blinded Independent Central Review (BICR) in Participants With Programmed Cell Death Ligand 1 (PD-L1) Combined Positive Score (CPS) =1
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Assessment method [5]
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ORR was defined as the percentage of the participants who had a confirmed Complete Response (CR: disappearance of all target lesions) or Partial Response (PR: =30% decrease in the sum of diameters (SOD) of target lesions, taking as reference the baseline SOD) according to RECIST 1.1 as assessed by BICR.
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Timepoint [5]
0
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Up to 49.5 months
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Secondary outcome [6]
0
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Objective Response Rate (ORR) Per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) Assessed by Blinded Independent Central Review (BICR) in Participants With Programmed Cell Death Ligand 1 (PD-L1) Combined Positive Score (CPS) =10
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Assessment method [6]
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ORR was defined as the percentage of the participants who had a confirmed Complete Response (CR: disappearance of all target lesions) or Partial Response (PR: =30% decrease in the sum of diameters (SOD) of target lesions, taking as reference the baseline SOD) according to RECIST 1.1 as assessed by BICR.
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Timepoint [6]
0
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Up to 49.5 months
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Secondary outcome [7]
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Duration of Response (DOR) Per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) Assessed by Blinded Independent Central Review (BICR) in All Participants
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Assessment method [7]
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DOR was defined as the time from first documented evidence of a confirmed Complete Response (CR) or Partial Response (PR) until progressive disease (PD) or death, whichever occurred first. Per RECIST 1.1 as assessed by BICR, CR was the disappearance of all target lesions and PR was =30% decrease in the sum of diameters (SOD) of target lesions, taking as reference the baseline SOD. PD was defined as =20% increase in the SOD of target lesions according to RECIST 1.1. In addition to the relative increase of 20%, the SOD must also have demonstrated an absolute increase of =5 mm. The appearance of =1 new lesions was also considered PD. DOR for participants who had not progressed or died at the time of analysis was censored at the date of the last tumor assessment. DOR was estimated using the product-limit (Kaplan-Meier) method for censored data.
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Timepoint [7]
0
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Up to 49.5 months
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Secondary outcome [8]
0
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Duration of Response (DOR) Per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) Assessed by Blinded Independent Central Review (BICR) in Participants With Programmed Cell Death Ligand 1 (PD-L1) Combined Positive Score (CPS) =1
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Assessment method [8]
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DOR was defined as the time from first documented evidence of a confirmed Complete Response (CR) or Partial Response (PR) until progressive disease (PD) or death, whichever occurred first. Per RECIST 1.1 as assessed by BICR, CR was the disappearance of all target lesions and PR was =30% decrease in the sum of diameters (SOD) of target lesions, taking as reference the baseline SOD. PD was defined as =20% increase in the SOD of target lesions according to RECIST 1.1. In addition to the relative increase of 20%, the SOD must also have demonstrated an absolute increase of =5 mm. The appearance of =1 new lesions was also considered PD. DOR for participants who had not progressed or died at the time of analysis was censored at the date of the last tumor assessment. DOR was estimated using the product-limit (Kaplan-Meier) method for censored data.
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Timepoint [8]
0
0
Up to 49.5 months
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Secondary outcome [9]
0
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Duration of Response (DOR) Per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) Assessed by Blinded Independent Central Review (BICR) in Participants With Programmed Cell Death Ligand 1 (PD-L1) Combined Positive Score (CPS) =10
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Assessment method [9]
0
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DOR was defined as the time from first documented evidence of a confirmed Complete Response (CR) or Partial Response (PR) until progressive disease (PD) or death, whichever occurred first. Per RECIST 1.1 as assessed by BICR, CR was the disappearance of all target lesions and PR was =30% decrease in the sum of diameters (SOD) of target lesions, taking as reference the baseline SOD. PD was defined as =20% increase in the SOD of target lesions according to RECIST 1.1. In addition to the relative increase of 20%, the SOD must also have demonstrated an absolute increase of =5 mm. The appearance of =1 new lesions was also considered PD. DOR for participants who had not progressed or died at the time of analysis was censored at the date of the last tumor assessment. DOR was estimated using the product-limit (Kaplan-Meier) method for censored data.
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Timepoint [9]
0
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Up to 49.5 months
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Secondary outcome [10]
0
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Number of Participants Who Experienced an Adverse Event (AE)
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Assessment method [10]
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An AE was defined as any untoward medical occurrence, in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. An AE could therefore have been any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a study intervention. The number of participants with at least one AE is presented.
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Timepoint [10]
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Up to 36.7 months
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Secondary outcome [11]
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Number of Participants Who Discontinued Study Treatment Due To an Adverse Event (AE)
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Assessment method [11]
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An AE was defined as any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. An AE could therefore have been any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a study intervention. The number of participants who discontinued study treatment due to an AE is presented.
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Timepoint [11]
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Up to 33.7 months
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Eligibility
Key inclusion criteria
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 treatment period and
through 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 through 180
days after the last dose of chemotherapy or through 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
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
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 24 hours for urine or within
72 hours for serum 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-programmed cell death (PD)-1, anti-PD-L1 or
anti-programmed cell death ligand 2 (PD-L2) agent or with an agent directed to another
stimulatory or co-inhibitory 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 adverse events (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 non-central 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
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
The people receiving the treatment/s
The people analysing the results/data
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 3
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Active, not recruiting
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
8/11/2018
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
28/09/2024
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Actual
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Sample size
Target
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Accrual to date
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Final
1579
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Recruitment in Australia
Recruitment state(s)
NSW,VIC
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Recruitment hospital [1]
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Liverpool Hospital ( Site 2301) - Liverpool
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Recruitment hospital [2]
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Southern Medical Day Care Centre ( Site 2303) - Wollongong
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Recruitment hospital [3]
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Box Hill Hospital ( Site 2300) - Box Hill
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Recruitment postcode(s) [1]
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2170 - Liverpool
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Recruitment postcode(s) [2]
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2500 - Wollongong
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Recruitment postcode(s) [3]
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3128 - Box Hill
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Recruitment outside Australia
Country [1]
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United States of America
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California
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0
0
United States of America
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Florida
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Maryland
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Minnesota
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New York
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Pennsylvania
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0
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Virginia
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0
United States of America
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Washington
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Argentina
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State/province [9]
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Caba
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0
0
Argentina
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0
Buenos Aires
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Argentina
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La Rioja
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Argentina
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San Juan
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0
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Brazil
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Ceara
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0
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Brazil
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Parana
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Brazil
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Rio Grande Do Sul
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Brazil
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Santa Catarina
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Brazil
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Rio de Janeiro
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Brazil
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Sao Paulo
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0
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Canada
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British Columbia
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Canada
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Ontario
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Canada
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Quebec
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Chile
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Araucania
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Chile
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Region M. De Santiago
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China
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Beijing
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China
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Fujian
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0
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China
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Guangdong
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China
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Hebei
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China
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Heilongjiang
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China
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Henan
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China
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Hubei
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China
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Hunan
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China
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Jiangsu
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China
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Jiangxi
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China
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Jilin
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China
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Shandong
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China
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Shanghai
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China
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Shanxi
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0
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China
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Xinjiang
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0
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China
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0
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Zhejiang
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0
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Colombia
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Cesar
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Colombia
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Cordoba
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Colombia
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Distrito Capital De Bogota
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Colombia
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Valle Del Cauca
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Costa Rica
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San Jose
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Czechia
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Jihomoravsky Kraj
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Czechia
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Moravskoslezsky Kraj
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Czechia
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Plzensky Kraj
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Czechia
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Novy Jicin
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Czechia
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Olomouc
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Czechia
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Praha 4
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Denmark
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Hovedstaden
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Denmark
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Nordjylland
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Denmark
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Syddanmark
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France
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Ain
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France
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Doubs
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France
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Finistere
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France
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Nord
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France
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Val-de-Marne
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France
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Paris
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Germany
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Baden-Wurttemberg
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Germany
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Sachsen
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Germany
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Berlin
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Germany
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Hamburg
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Guatemala
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Guatemala
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Quetzaltenango
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Hong Kong
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Hong Kong
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Hungary
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Bacs-Kiskun
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Hungary
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Jasz-Nagykun-Szolnok
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Hungary
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Budapest
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Hungary
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Debrecen
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Ireland
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Dublin
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Israel
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Tel Aviv
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Israel
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Tell Abib
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Israel
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Yerushalayim
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Israel
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Beer Sheva
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Israel
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Haifa
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Israel
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Kfar Saba
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Israel
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Petah Tikva
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Italy
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Lombardia
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Italy
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Milano
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Italy
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Padova
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Italy
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Roma
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Japan
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Aichi
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Japan
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Chiba
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Japan
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Hyogo
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Japan
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Ibaraki
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Japan
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Kagawa
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Japan
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Kanagawa
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Japan
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Osaka
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Japan
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Saitama
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Japan
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Fukuoka
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Japan
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Hiroshima
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Japan
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Kumamoto
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Japan
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Niigata
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Japan
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Tokyo
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Korea, Republic of
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Seoul
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Mexico
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Jalisco
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Mexico
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Nuevo Leon
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Mexico
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Ciudad de Mexico
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Mexico
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Merida
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Mexico
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Mexico City
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New Zealand
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Northland
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Peru
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Lima
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Poland
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Dolnoslaskie
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Poland
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Malopolskie
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Poland
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Mazowieckie
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Poland
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Wielkopolskie
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Poland
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Grudziadz
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Russian Federation
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Chelyabinskaya Oblast
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Russian Federation
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Leningradskaya Oblast
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Russian Federation
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Moskva
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Russian Federation
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Samarskaya Oblast
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Russian Federation
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Sankt-Peterburg
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South Africa
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Eastern Cape
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South Africa
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Free State
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South Africa
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Gauteng
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South Africa
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Kwazulu-Natal
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South Africa
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Western Cape
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Spain
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Alicante
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Spain
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Asturias
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Spain
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Barcelona
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Spain
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Cantabria
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Spain
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Madrid
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Switzerland
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Basel-Stadt
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Switzerland
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Geneve
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Switzerland
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Grisons
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Switzerland
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Sankt Gallen
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Switzerland
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Ticino
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Switzerland
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Zurich
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Switzerland
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Luzern
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Taiwan
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Kaohsiung
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Taiwan
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Tainan
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Taiwan
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Taipei
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Turkey
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Adana
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Turkey
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Ankara
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Turkey
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Edirne
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Turkey
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Erzurum
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Turkey
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Istanbul
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Turkey
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Izmir
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Turkey
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Malatya
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Turkey
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Sakarya
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Ukraine
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Dnipropetrovska Oblast
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Ukraine
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Ivano-Frankivska Oblast
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Ukraine
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Kharkivska Oblast
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Ukraine
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Kyivska Oblast
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Ukraine
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Lvivska Oblast
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Ukraine
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Odeska Oblast
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Ukraine
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Zaporizka Oblast
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Ukraine
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Kyiv
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United Kingdom
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Devon
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United Kingdom
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East Riding Of Yorkshire
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United Kingdom
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London, City Of
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Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
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Name
Merck Sharp & Dohme LLC
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Address
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Ethics approval
Ethics application status
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Summary
Brief 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 participants.
The primary hypotheses of this study are that pembrolizumab plus chemotherapy is superior to
placebo plus chemotherapy in terms of overall survival (OS).
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Trial website
https://clinicaltrials.gov/ct2/show/NCT03675737
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Public notes
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Contacts
Principal investigator
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Medical Director
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Address
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Merck Sharp & Dohme LLC
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT03675737
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