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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT03675737




Registration number
NCT03675737
Ethics application status
Date submitted
17/09/2018
Date registered
18/09/2018

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)
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)
Secondary ID [1] 0 0
MK-3475-859
Secondary ID [2] 0 0
3475-859
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Stomach Neoplasms 0 0
Condition category
Condition code
Cancer 0 0 0 0
Stomach

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Other - 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).


Treatment: Other: 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
Intervention code [1] 0 0
Treatment: Other
Intervention code [2] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Overall Survival (OS) in All Participants
Timepoint [1] 0 0
Up to 45.9 months
Primary outcome [2] 0 0
Overall Survival (OS) In Participants With Programmed Cell Death Ligand 1 (PD-L1) Combined Positive Score (CPS) =1
Timepoint [2] 0 0
Up to 45.9 months
Primary outcome [3] 0 0
Overall Survival (OS) In Participants With Programmed Cell Death Ligand 1 (PD-L1) Combined Positive Score (CPS) =10
Timepoint [3] 0 0
Up to 45.9 months
Secondary outcome [1] 0 0
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
Timepoint [1] 0 0
Up to 49.5 months
Secondary outcome [2] 0 0
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
Timepoint [2] 0 0
Up to 49.5 months
Secondary outcome [3] 0 0
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
Timepoint [3] 0 0
Up to 49.5 months
Secondary outcome [4] 0 0
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
Timepoint [4] 0 0
Up to 49.5 months
Secondary outcome [5] 0 0
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
Timepoint [5] 0 0
Up to 49.5 months
Secondary outcome [6] 0 0
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
Timepoint [6] 0 0
Up to 49.5 months
Secondary outcome [7] 0 0
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
Timepoint [7] 0 0
Up to 49.5 months
Secondary outcome [8] 0 0
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
Timepoint [8] 0 0
Up to 49.5 months
Secondary outcome [9] 0 0
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
Timepoint [9] 0 0
Up to 49.5 months
Secondary outcome [10] 0 0
Number of Participants Who Experienced an Adverse Event (AE)
Timepoint [10] 0 0
Up to 36.7 months
Secondary outcome [11] 0 0
Number of Participants Who Discontinued Study Treatment Due To an Adverse Event (AE)
Timepoint [11] 0 0
Up to 33.7 months

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
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
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

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s


The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Active, not recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
8/11/2018
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/03/2025
Actual
Sample size
Target
Accrual to date
Final
1579
Recruitment in Australia
Recruitment state(s)
NSW,VIC
Recruitment hospital [1] 0 0
Liverpool Hospital ( Site 2301) - Liverpool
Recruitment hospital [2] 0 0
Southern Medical Day Care Centre ( Site 2303) - Wollongong
Recruitment hospital [3] 0 0
Box Hill Hospital ( Site 2300) - Box Hill
Recruitment postcode(s) [1] 0 0
2170 - Liverpool
Recruitment postcode(s) [2] 0 0
2500 - Wollongong
Recruitment postcode(s) [3] 0 0
3128 - Box Hill
Recruitment outside Australia
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United States of America
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California
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United States of America
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Florida
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Maryland
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United States of America
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Minnesota
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New York
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Pennsylvania
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Virginia
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Washington
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Caba
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Buenos Aires
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La Rioja
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San Juan
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Ceara
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Brazil
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Santa Catarina
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Brazil
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Chile
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Finistere
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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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Jasz-Nagykun-Szolnok
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Tel Aviv
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Tell Abib
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Haifa
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Kfar Saba
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Jalisco
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Ciudad de 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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Malopolskie
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Mazowieckie
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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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Eastern Cape
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Free State
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Gauteng
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Western Cape
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Alicante
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Spain
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Spain
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Barcelona
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Spain
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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
Country [151] 0 0
United Kingdom
State/province [151] 0 0
East Riding Of Yorkshire
Country [152] 0 0
United Kingdom
State/province [152] 0 0
London, City Of

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Merck Sharp & Dohme LLC
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Medical Director
Address 0 0
Merck Sharp & Dohme LLC
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
http://engagezone.msd.com/doc/ProcedureAccessClinicalTrialData.pdf
When will data be available (start and end dates)?
Available to whom?
Available for what types of analyses?
How or where can data be obtained?
IPD available at link: http://engagezone.msd.com/ds_documentation.php


What supporting documents are/will be available?




Results publications and other study-related documents

TypeCitations or Other Details
Journal Rha SY, Oh DY, Yanez P, Bai Y, Ryu MH, Lee J, Rive... [More Details]


Results are available at https://clinicaltrials.gov/study/NCT03675737