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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT02625610




Registration number
NCT02625610
Ethics application status
Date submitted
4/12/2015
Date registered
9/12/2015
Date last updated
9/06/2022

Titles & IDs
Public title
Avelumab in First-Line Maintenance Gastric Cancer (JAVELIN Gastric 100)
Scientific title
A Phase III Open-label, Multicenter Trial of Maintenance Therapy With Avelumab (MSB0010718C) Versus Continuation of First-line Chemotherapy in Subjects With Unresectable, Locally Advanced or Metastatic, Adenocarcinoma of the Stomach, or of the Gastro-esophageal Junction
Secondary ID [1] 0 0
2015-003300-23
Secondary ID [2] 0 0
EMR 100070-007
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Unresectable, Locally Advanced or Metastatic, Adenocarcinoma of the Stomach, or of the Gastro Esophageal Junction 0 0
Condition category
Condition code

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Avelumab
Treatment: Drugs - Oxaliplatin
Treatment: Drugs - 5-Fluorouracil
Treatment: Drugs - Leucovorin
Treatment: Drugs - Capecitabine
Other interventions - Best supportive care
Treatment: Drugs - Oxaliplatin
Treatment: Drugs - 5-Fluorouracil
Treatment: Drugs - Leucovorin
Treatment: Drugs - Capecitabine

Experimental: Chemotherapy + Best Supportive Care (BSC) - In Maintenance Phase, participants continued the same regimen of oxaliplatin-fluoropyrimidine doublet chemotherapy (oxaliplatin + 5FU/LV or oxaliplatin + capecitabine) as they received during the Induction Phase until disease progression, significant clinical deterioration, unacceptable toxicity, or discontinuation. Participants who were not deemed eligible to receive chemotherapy at the dose and schedule specified above received BSC alone once every 3 weeks. BSC was defined as treatment administered with the intent to maximize quality of life without a specific antineoplastic regimen and was based on Investigator's discretion.

Experimental: Avelumab - In Maintenance phase, participants received avelumab as a 1-hour intravenous (IV) infusion at 10 milligrams per kilogram (mg/kg) once every 2-week treatment cycle until progressive disease or unacceptable toxicity or discontinuation.


Treatment: Drugs: Avelumab
Maintenance Phase: Intravenous (IV) infusion (10 mg/kg over 1 hour) once every 2 weeks.

Treatment: Drugs: Oxaliplatin
Induction Phase: Oxaliplatin was administered at a dose of 85 mg per square meter (mg/m\^2) as a continuous intravenous (IV) infusion on Day 1 along with leucovorin followed by 5-Fluorouracil every 2 weeks up to 12 weeks (or) Oxaliplatin at 130 mg/m\^2 IV on Day 1 along with capecitabine twice daily for 2 weeks followed by a 1-week rest period given every 3 weeks up to 12 weeks.

Maintenance Phase: Participants were continued the same regimen of chemotherapy as they received during the Induction Phase until disease progression, significant clinical deterioration, unacceptable toxicity, or discontinuation.

Treatment: Drugs: 5-Fluorouracil
Induction Phase: 5-Fluorouracil was administered at a dose of 2600 mg/m\^2 IV continuous infusion over 24 hours on Day 1 (or) 5-FU at 400 mg/m\^2 IV push on Day 1 and 2400 mg/m\^2 IV continuous infusion over 46-48 hours (Days 1 and 2) along with oxaliplatin and leucovorin every 2 weeks up to 12 weeks. Maintenance Phase: Participants were continued the same regimen of chemotherapy as they received during the Induction Phase until disease progression, significant clinical deterioration, unacceptable toxicity, or discontinuation.

Treatment: Drugs: Leucovorin
Induction Phase: Leucovorin was administered at a dose of 200 mg/m\^2 IV (or) Leucovorin 400 mg/m\^2 IV on Day 1 along with oxaliplatin and 5-FU every 2 weeks up to 12 weeks.

Maintenance Phase: Participants were continued the same regimen of chemotherapy as they received during the Induction Phase until disease progression, significant clinical deterioration, unacceptable toxicity, or discontinuation.

Treatment: Drugs: Capecitabine
Induction Phase: Capecitabine was administered at a dose of 1000 mg/m\^2 twice daily for 2 weeks followed by a 1-week rest period given every 3 weeks along with oxaliplatin up to 12 weeks.

Maintenance Phase: Participants were continued the same regimen of chemotherapy as they received during the Induction Phase every 3 weeks until disease progression, significant clinical deterioration, unacceptable toxicity, or discontinuation.

Other interventions: Best supportive care
Treatment administered with the intent to maximize Quality of Life (QoL) without a specific antineoplastic regimen. These may include for example antibiotics, analgesics, antiemetics, thoracentesis, paracentesis, blood transfusions, nutritional support (including jejunostomy), and focal external-beam radiation for control of pain, cough, dyspnea, or bleeding. Best supportive care were administered per institutional guidelines and participants were visit the clinic every 3 weeks.

Treatment: Drugs: Oxaliplatin
Induction Phase: Oxaliplatin will be administered at a dose of 85 mg per square meter (mg/m\^2) as a continuous intravenous (IV) infusion on Day 1 along with leucovorin followed by 5-Fluorouracil every 2 weeks up to 12 weeks (or) Oxaliplatin at 130 mg/m\^2 IV on Day 1 along with capecitabine twice daily for 2 weeks followed by a 1-week rest period given every 3 weeks up to 12 weeks.

Treatment: Drugs: 5-Fluorouracil
Induction Phase: 5-Fluorouracil will be administered at a dose of 2600 mg/m\^2 IV continuous infusion over 24 hours on Day 1 (or) 5-FU at 400 mg/m\^2 IV push on Day 1 and 2400 mg/m\^2 IV continuous infusion over 46-48 hours (Days 1 and 2) along with oxaliplatin and leucovorin every 2 weeks up to 12 weeks.

Treatment: Drugs: Leucovorin
Induction Phase: Leucovorin will be administered at a dose of 200 mg/m\^2 IV (or) Leucovorin 400 mg/m\^2 IV on Day 1 along with oxaliplatin and 5-FU every 2 weeks up to 12 weeks.

Treatment: Drugs: Capecitabine
Induction Phase: Capecitabine will be administered at a dose of 1000 mg/m\^2 twice daily for 2 weeks followed by a 1-week rest period given every 3 weeks along with oxaliplatin up to 12 weeks.
Intervention code [1] 0 0
Treatment: Drugs
Intervention code [2] 0 0
Other interventions
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Overall Survival (OS)
Timepoint [1] 0 0
From randomization into maintenance phase up to 1276 days
Secondary outcome [1] 0 0
Progression Free Survival (PFS) by Independent Review Committee (IRC)
Timepoint [1] 0 0
From randomization into maintenance phase up to 1276 days
Secondary outcome [2] 0 0
Best Overall Response (BOR) by Investigator Assessment
Timepoint [2] 0 0
From randomization into maintenance phase up to 1276 days
Secondary outcome [3] 0 0
Objective Response Rate (ORR) by Investigator Assessment
Timepoint [3] 0 0
From randomization into maintenance phase up to 1276 days
Secondary outcome [4] 0 0
Change From Baseline in European Quality of Life 5-dimensions (EQ-5D-5L) Health Outcome Questionnaire Through Composite Index Score up to Safety Follow-up (Up to 152.3 Weeks)
Timepoint [4] 0 0
Baseline, Week 3/4, Week 7, Week 13, Week 19, Week 25, Week 31, Week 37, Week 43, Week 49, Week 55, Week 61, Week 67, End of Treatment ( EOT up to 148 weeks) and Safety Follow-up (Up to 152.3 Weeks)
Secondary outcome [5] 0 0
Change From Baseline in European Quality of Life 5-dimensions Health Outcome Questionnaire Through Visual Analogue Scale up to Safety Follow-up (Up to 152.3 Weeks)
Timepoint [5] 0 0
Baseline, Week 3/4, Week 7, Week 13, Week 19, Week 25, Week 31, Week 37, Week 43, Week 49, Week 55, Week 61, Week 67, End of Treatment ( EOT up to 148 weeks) and Safety Follow-up (Up to 152.3 Weeks)
Secondary outcome [6] 0 0
Change From Baseline in European Organization for the Research and Treatment of Cancer Quality of Life (EORTC QLQ-C30) Global Health Status Scale Score up to Safety Follow-up (Up to 152.3 Weeks)
Timepoint [6] 0 0
Baseline, Week 3/4, Week 7, Week 13, Week 19, Week 25, Week 31, Week 37, Week 43, Week 49, Week 55, Week 61, Week 67, End of Treatment ( EOT up to 148 weeks) and Safety Follow-up (Up to 152.3 Weeks)
Secondary outcome [7] 0 0
Change From Baseline in European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire-Stomach Cancer Specific (EORTC QLQ-STO22 ) Questionnaire Scores up to Safety Follow-up (Up to 152.3 Weeks)
Timepoint [7] 0 0
Baseline, Week 3/4, Week 7, Week 13, Week 19, Week 25, Week 31, Week 37, Week 43, Week 49, Week 55, Week 61, Week 67, End of Treatment ( EOT up to 148 weeks) and Safety Follow-up (Up to 152.3 Weeks)
Secondary outcome [8] 0 0
Maintenance Phase: Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Serious TEAEs According to National Cancer Institute-Common Terminology Criteria for Adverse Events Version 4.03 (NCI-CTCAE v4.03)
Timepoint [8] 0 0
From randomization into maintenance phase up to 1276 days
Secondary outcome [9] 0 0
Maintenance Phase: Number of Participants With Grade Change From Baseline to Worst On-Treatment Grade 4 Hematology Values
Timepoint [9] 0 0
From baseline up to 1276 days
Secondary outcome [10] 0 0
Maintenance Phase: Number of Participants With Potentially Clinically Significant Abnormalities in Vital Signs
Timepoint [10] 0 0
From randomization into maintenance phase up to 1276 days
Secondary outcome [11] 0 0
Maintenance Phase: Number of Participants With Potentially Clinically Significant Electrocardiogram (ECG) Abnormalities
Timepoint [11] 0 0
From randomization into maintenance phase up to 1276 days
Secondary outcome [12] 0 0
Maintenance Phase: Number of Participants With Shift in Eastern Cooperative Oncology Group (ECOG) Performance Status Score to 1 or Higher Than 1
Timepoint [12] 0 0
From randomization into maintenance phase up to 1276 days

Eligibility
Key inclusion criteria
* Male or female participants greater than or equal to (>=) 18 years
* Disease must be measurable by Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1)
* Participants with histologically confirmed unresectable locally advanced or metastatic adenocarcinoma of the stomach or gastro-esophageal junction (GEJ)
* Eastern Cooperative Oncology Group Performance Status (ECOG PS) of 0 to 1 at trial entry
* Estimated life expectancy of more than 12 weeks
* Adequate haematological, hepatic and renal functions defined by the protocol
* Negative blood pregnancy test at Screening for women of childbearing potential
* Highly effective contraception for both male and female participants if the risk of conception exists
* Other protocol defined inclusion criteria could apply
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* Prior therapy with any antibody or drug targeting T-cell coregulatory proteins
* Concurrent anticancer treatment or immunosuppressive agents
* Prior chemotherapy for unresectable locally advanced or metastatic adenocarcinoma of the stomach or gastro-esophageal junction (GEJ)
* Tumor shown to be human epidermal growth factor 2 plus (HER2+)
* Major surgery for any reason, except diagnostic biopsy, within 4 weeks of enrolment and/or if the participant has not fully recovered from the surgery within 4 weeks of enrolment
* Participants receiving immunosuppressive agents (such as steroids) for any reason should be tapered off these drugs before initiation of the study treatment (with the exception of participants with adrenal insufficiency, who may continue corticosteroids at physiologic replacement dose, equivalent to <= 10 mg prednisone daily)
* All participants with brain metastases, except those meeting the following criteria: a. Brain metastases have been treated locally, have not been progressing at least 2 months after completion of therapy, and no steroid maintenance therapy is required, and b. No ongoing neurological symptoms that are related to the brain localization of the disease (sequelae that are a consequence of the treatment of the brain metastases are acceptable)
* Previous malignant disease (other than gastric cancer) within the last 5 years with the exception of basal or squamous cell carcinoma of the skin or carcinoma in situ (bladder, cervical, colorectal, breast)
* Prior organ transplantation, including allogeneic stem-cell transplantation
* Significant acute or chronic infections
* Active autoimmune disease that might deteriorate when receiving an immunostimulatory agent
* Known severe hypersensitivity reactions to monoclonal antibodies, any history of anaphylaxis, or uncontrolled asthma (that is, 3 or more features of partially controlled asthma)
* Persisting toxicity related to prior therapy except alopecia
* Neuropathy Grade > 3
* Pregnancy or lactation
* Known alcohol or drug abuse
* History of uncontrolled intercurrent illness including hypertension, active infection, diabetes
* Clinically significant (i.e., active) cardiovascular disease
* All other significant diseases might impair the participant's tolerance of study treatment
* Any psychiatric condition that would prohibit the understanding or rendering of informed consent and that would limit compliance with study requirements
* Vaccination with live or live/attenuated viruses within 55 days of the first dose of avelumab and while on trial is prohibited except for administration of inactivated vaccines
* Legal incapacity or limited legal capacity
* Participants will be excluded from the Induction Phase and the Maintenance Phase if administration of their chemotherapy would be inconsistent with the current local labelling (SmPC) (e.g., in regard to contraindications, warnings/precautions or special provisions) for that chemotherapy. Investigators should check updated labelling via relevant websites at the time of entry into the Induction Phase and the Maintenance Phase
* Other protocol defined exclusion criteria could apply

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
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Other
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
24/12/2015
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
3/06/2021
Sample size
Target
Accrual to date
Final
499
Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA,TAS,VIC,WA
Recruitment hospital [1] 0 0
St George Hospital - Kogarah
Recruitment hospital [2] 0 0
Royal North Shore Hospital - St Leonards
Recruitment hospital [3] 0 0
Greenslopes Private Hospital - Greenslopes
Recruitment hospital [4] 0 0
Royal Brisbane and Women's Hospital - Herston
Recruitment hospital [5] 0 0
Flinders Medical Centre - Bedford Park
Recruitment hospital [6] 0 0
Lyell McEwin Hospital - Elizabeth Vale
Recruitment hospital [7] 0 0
Royal Hobart Hospital - Hobart
Recruitment hospital [8] 0 0
Ballarat Base Hospital - Ballarat
Recruitment hospital [9] 0 0
Bendigo Hospital - Bendigo
Recruitment hospital [10] 0 0
Monash Medical Centre Clayton - Bentleigh
Recruitment hospital [11] 0 0
Box Hill Hospital - Box Hill
Recruitment hospital [12] 0 0
Royal Melbourne Hospital - Parkville
Recruitment hospital [13] 0 0
Border Medical Oncology - Wodonga
Recruitment hospital [14] 0 0
Fiona Stanley Hospital - Murdoch
Recruitment postcode(s) [1] 0 0
2217 - Kogarah
Recruitment postcode(s) [2] 0 0
2065 - St Leonards
Recruitment postcode(s) [3] 0 0
4120 - Greenslopes
Recruitment postcode(s) [4] 0 0
4006 - Herston
Recruitment postcode(s) [5] 0 0
5042 - Bedford Park
Recruitment postcode(s) [6] 0 0
5112 - Elizabeth Vale
Recruitment postcode(s) [7] 0 0
7000 - Hobart
Recruitment postcode(s) [8] 0 0
3350 - Ballarat
Recruitment postcode(s) [9] 0 0
3550 - Bendigo
Recruitment postcode(s) [10] 0 0
8120 - Bentleigh
Recruitment postcode(s) [11] 0 0
3128 - Box Hill
Recruitment postcode(s) [12] 0 0
3050 - Parkville
Recruitment postcode(s) [13] 0 0
3690 - Wodonga
Recruitment postcode(s) [14] 0 0
6150 - Murdoch
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
California
Country [2] 0 0
United States of America
State/province [2] 0 0
Connecticut
Country [3] 0 0
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State/province [3] 0 0
Florida
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United States of America
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Illinois
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Indiana
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Kansas
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Minnesota
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Nevada
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New York
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Ohio
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Oregon
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Pennsylvania
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Rhode Island
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South Carolina
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United States of America
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Texas
Country [17] 0 0
United States of America
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Washington
Country [18] 0 0
Brazil
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Bahia
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Brazil
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Rio Grande Do Sul
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Brazil
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Sao Paulo
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Brazil
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Badajoz
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Canada
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Nova Scotia
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Ontario
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Quebec
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France
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Alpes Maritimes
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Bouches Du Rhone
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Brittany
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France
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Côte-d'Or
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Doubs
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Gironde
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Ille Et Vilaine
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Indre Et Loire
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France
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Maine Et Loire
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France
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Paris
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France
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Puy De Dome
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France
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Sarthe
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Germany
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Baden Wuerttemberg
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Germany
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Bayern
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Germany
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Hessen
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Germany
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Rheinland Pfalz
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Germany
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Hamburg
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Hungary
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Baranya
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Hungary
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Gyor-Moson-Sopron
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Hajdú-Bihar
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Nyiregyhaza
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Szolnok
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Catania
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Cremona
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Firenze
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Milano
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Napoli
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Italy
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Padova
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Italy
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Rimini
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Italy
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Roma
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Italy
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Terni
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Italy
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Udine
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Japan
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Chiba-Ken
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Japan
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Kagawa-Ken
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Japan
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Kanagawa-Ken
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Japan
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Kumamoto-Ken
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Miyagi-Ken
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Niigata-Ken
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Japan
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Oita-ken
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Osaka-Fu
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Osaka
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Saitama-Ken
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Tochigi-Ken
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Tokyo-To
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Japan
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Kagoshima-shi
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Korea, Republic of
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Chungcheongbuk-do
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Gyeonggi-do
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Korea, Republic of
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Jeollanam-do
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Korea, Republic of
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Jung-gu
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Korea, Republic of
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Busan
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Korea, Republic of
State/province [79] 0 0
Daegu
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Korea, Republic of
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Seoul
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Romania
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Cluj
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Romania
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Dolj
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Romania
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Prahova
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Romania
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Timis
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Romania
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Baia Mare
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Romania
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Bucuresti
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Romania
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Iasi
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Russian Federation
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Leningrado
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Russian Federation
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Arkhangelsk
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Russian Federation
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Chelyabinsk
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Russian Federation
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Ivanovo
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Russian Federation
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Krasnodar
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Russian Federation
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Moscow
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Russian Federation
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Omsk
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Russian Federation
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Pyatigorsk
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Russian Federation
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Saint-Petersburg
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Spain
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Alicante
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Spain
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Barcelona
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Spain
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Madrid
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Spain
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Sevilla
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Taiwan
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Kaohsiung
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Taiwan
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Taichung
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Taiwan
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Tainan
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Taiwan
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Taipei
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Taiwan
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Taoyuan
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Thailand
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Bangkok
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Thailand
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Chiang Mai
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Turkey
State/province [108] 0 0
Adana
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Turkey
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Ankara
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Turkey
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Antalya
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Turkey
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Diyarbakir
Country [112] 0 0
Turkey
State/province [112] 0 0
Istanbul
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Turkey
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Kocaeli
Country [114] 0 0
Turkey
State/province [114] 0 0
Konya
Country [115] 0 0
Turkey
State/province [115] 0 0
Malatya
Country [116] 0 0
Turkey
State/province [116] 0 0
Mersin
Country [117] 0 0
United Kingdom
State/province [117] 0 0
Devon
Country [118] 0 0
United Kingdom
State/province [118] 0 0
Greater London
Country [119] 0 0
United Kingdom
State/province [119] 0 0
Greater Manchester
Country [120] 0 0
United Kingdom
State/province [120] 0 0
Merseyside
Country [121] 0 0
United Kingdom
State/province [121] 0 0
Middlesex
Country [122] 0 0
United Kingdom
State/province [122] 0 0
Surrey
Country [123] 0 0
United Kingdom
State/province [123] 0 0
Tayside Region
Country [124] 0 0
United Kingdom
State/province [124] 0 0
West Yorkshire

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
EMD Serono Research & Development Institute, Inc.
Address
Country
Other collaborator category [1] 0 0
Commercial sector/industry
Name [1] 0 0
Merck KGaA, Darmstadt, Germany
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

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

Contacts
Principal investigator
Name 0 0
Medical Responsible
Address 0 0
EMD Serono Research & Development Institute, Inc. a business of Merck KGaA, Darmstadt, Germany
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No information has been provided regarding IPD availability


What supporting documents are/will be available?




Results publications and other study-related documents

No documents have been uploaded by study researchers.

Results are available at https://clinicaltrials.gov/study/NCT02625610