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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/NCT04223856
Registration number
NCT04223856
Ethics application status
Date submitted
6/01/2020
Date registered
10/01/2020
Date last updated
30/05/2024
Titles & IDs
Public title
Enfortumab Vedotin and Pembrolizumab vs. Chemotherapy Alone in Untreated Locally Advanced or Metastatic Urothelial Cancer
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Scientific title
An Open-label, Randomized, Controlled Phase 3 Study of Enfortumab Vedotin in Combination With Pembrolizumab Versus Chemotherapy Alone in Previously Untreated Locally Advanced or Metastatic Urothelial Cancer
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Secondary ID [1]
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2019-004542-15
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Secondary ID [2]
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SGN22E-003
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Universal Trial Number (UTN)
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Trial acronym
EV-302
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Urothelial Cancer
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0
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Condition category
Condition code
Intervention/exposure
Study type
Interventional(has expanded access)
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Description of intervention(s) / exposure
Treatment: Drugs - Enfortumab vedotin
Treatment: Drugs - Pembrolizumab
Treatment: Drugs - Cisplatin
Treatment: Drugs - Carboplatin
Treatment: Drugs - Gemcitabine
Experimental: Arm A - Enfortumab vedotin + pembrolizumab
Active Comparator: Arm B - Gemcitabine + cisplatin or carboplatin
Experimental: Arm C (Not Recruiting) - Enfortumab vedotin + pembrolizumab + Cisplatin or carboplatin
Treatment: Drugs: Enfortumab vedotin
Enfortumab vedotin administered as an IV infusion on Days 1 and 8 of every 3-week cycle
Treatment: Drugs: Pembrolizumab
IV infusion on Day 1 of every 3-week cycle
Treatment: Drugs: Cisplatin
administered as IV infusion on Day 1 of each 3-week cycle
Treatment: Drugs: Carboplatin
Dosed according to local guidelines and will be administered as IV infusion on Day 1 of each 3-week cycle
Treatment: Drugs: Gemcitabine
IV infusion on Days 1 and 8 of every 3 week cycle
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Intervention code [1]
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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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Duration of progression-free survival (PFS) per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 by blinded independent central review (BICR) (Arms A and B only, global population)
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Assessment method [1]
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Defined as the time from randomization to first documentation of disease progression per RECIST v1.1 by BICR, or to death due to any cause, whichever comes first.
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Timepoint [1]
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Up to approximately 5 years
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Primary outcome [2]
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Duration of Overall survival (OS) (Arms A and B only, global population)
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Assessment method [2]
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OS is defined as the time from date of randomization to date of death due to any cause.
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Timepoint [2]
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Up to approximately 5 years
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Secondary outcome [1]
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Objective response rate (ORR) per RECIST v1.1 by BICR (Arms A and B only)
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Assessment method [1]
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Defined as the proportion of subjects with confirmed CR or PR according to RECIST v1.1
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Timepoint [1]
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Up to approximately 5 years
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Secondary outcome [2]
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Time to pain progression (TTPP) (Arms A and B only)
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Assessment method [2]
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Defined as the time from randomization to the first date a subject experiences a pain progression. Pain progression is defined as either an increase of 2 or more points from baseline on question 3 of the Brief Pain Inventory - Short Form (BPI-SF) or initiation of new opioid pain medication.
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Timepoint [2]
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Up to approximately 5 years
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Secondary outcome [3]
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Mean change from baseline in worst pain at Week 26 (Arms A and B only)
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Assessment method [3]
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Using the BPI-SF question 3, mean change from baseline in worst pain will be calculated for each postbaseline assessment timepoint for Arm A and Arm B.
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Timepoint [3]
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Up to approximately 6 months
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Secondary outcome [4]
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Duration of PFS per RECIST v1.1 by investigator assessment (Arms A and B only)
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Assessment method [4]
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Defined as the time from randomization to first documentation of disease progression per RECIST v1.1, or to death due to any cause, whichever comes first
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Timepoint [4]
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0
Up to approximately 5 years
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Secondary outcome [5]
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ORR per RECIST v1.1 by investigator assessment (Arms A and B only)
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Assessment method [5]
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Defined as the proportion of subjects with confirmed CR or PR according to RECIST v1.1
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Timepoint [5]
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Up to approximately 5 years
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Secondary outcome [6]
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Duration of response (DOR) per RECIST v1.1 by BICR (Arms A and B only)
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Assessment method [6]
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Defined as the time from first documented response of CR or PR (that is subsequently confirmed) to the first documented disease progression per RECIST v1.1, or to death due to any cause, whichever comes first
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Timepoint [6]
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0
Up to approximately 5 years
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Secondary outcome [7]
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DOR per RECIST v1.1 by investigator assessment (Arms A and B only)
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Assessment method [7]
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Defined as the time from first documented response of CR or PR (that is subsequently confirmed) to the first documented disease progression per RECIST v1.1, or to death due to any cause, whichever comes first
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Timepoint [7]
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Up to approximately 5 years
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Secondary outcome [8]
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Disease control rate (DCR) per RECIST v1.1 by BICR (Arms A and B only)
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Assessment method [8]
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Defined as the proportion of subjects with confirmed CR, PR, or SD according to RECIST v1.1
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Timepoint [8]
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Up to approximately 5 years
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Secondary outcome [9]
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DCR per RECIST v1.1 by investigator assessment (Arms A and B only)
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Assessment method [9]
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0
Defined as the proportion of subjects with confirmed CR, PR, or SD according to RECIST v1.1
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Timepoint [9]
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Up to approximately 5 years
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Secondary outcome [10]
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Change from baseline in patient reported outcome assessment measured by the EuroQOL Five Dimensions Questionnaire 5L (EQ-5D-5L)
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Assessment method [10]
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The EQ-5D-5L is a standardized instrument developed by the EuroQol Group for use as a generic, preference-based measure of health outcomes. The EQ-5D-5L is a 5-item self-reported measure of functioning and wellbeing, which assesses 5 dimensions of health, including mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each dimension comprises 5 levels (no problems, slight problems, moderate problems, severe problems, extreme problems). A unique EQ-5D-5L health state is defined by combining 1 level from each of the 5 dimensions. This questionnaire also records the respondent's self-rated health status on a vertical graduated (0 = the worst health a participant can imagine to 100 = the best health a participant can imagine) visual analogue scale.
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Timepoint [10]
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Up to approximately 5 years
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Secondary outcome [11]
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Mean scores in patient reported outcome assessment measured by the EQ-5D-5L
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Assessment method [11]
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0
The EQ-5D-5L is a standardized instrument developed by the EuroQol Group for use as a generic, preference-based measure of health outcomes. The EQ-5D-5L is a 5-item self-reported measure of functioning and wellbeing, which assesses 5 dimensions of health, including mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each dimension comprises 5 levels (no problems, slight problems, moderate problems, severe problems, extreme problems). A unique EQ-5D-5L health state is defined by combining 1 level from each of the 5 dimensions. This questionnaire also records the respondent's self-rated health status on a vertical graduated (0 = the worst health a participant can imagine to 100 = the best health a participant can imagine) visual analogue scale.
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Timepoint [11]
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Up to approximately 5 years
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Secondary outcome [12]
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Change from baseline in patient reported outcome assessment measured by European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire Core 30 (QLQ-C30)
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Assessment method [12]
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EORTC-QLQ-C30 is a cancer-specific 30-item questionnaire. Participants rate items on a four-point scale, with 1 as "not at all" and 4 as "very much." A change of 5 - 10 points is considered a small change. A change of 10 - 20 points is considered a moderate change.
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Timepoint [12]
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Up to approximately 5 years
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Secondary outcome [13]
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Mean scores in patient reported outcome assessment measured by EORTC QLQ-C30
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Assessment method [13]
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EORTC-QLQ-C30 is a cancer-specific 30-item questionnaire. Participants rate items on a four-point scale, with 1 as "not at all" and 4 as "very much." A change of 5 - 10 points is considered a small change. A change of 10 - 20 points is considered a moderate change.
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Timepoint [13]
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Up to approximately 5 years
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Secondary outcome [14]
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Incidence of adverse events (AEs)
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Assessment method [14]
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Descriptive statistics will be used to summarize results
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Timepoint [14]
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Up to approximately 5 years
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Secondary outcome [15]
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Incidence of laboratory abnormalities
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Assessment method [15]
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Descriptive statistics will be used to summarize results
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Timepoint [15]
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Up to approximately 5 years
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Secondary outcome [16]
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Treatment discontinuation rate due to AEs
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Assessment method [16]
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Descriptive statistics will be used to summarize results
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Timepoint [16]
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Up to approximately 5 years
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Eligibility
Key inclusion criteria
- Histologically documented, unresectable locally advanced or metastatic urothelial
carcinoma
- Measurable disease by investigator assessment according to RECIST v1.1
- Participants with prior definitive radiation therapy must have measurable disease
per RECIST v1.1 that is outside the radiation field or has demonstrated
unequivocal progression since completion of radiation therapy
- Participants must not have received prior systemic therapy for locally advanced or
metastatic urothelial carcinoma with the following exceptions:
- Participants that received neoadjuvant chemotherapy with recurrence >12 months
from completion of therapy are permitted
- Participants that received adjuvant chemotherapy following cystectomy with
recurrence >12 months from completion of therapy are permitted
- Must be considered eligible to receive cisplatin- or carboplatin-containing
chemotherapy, in the investigator's judgment
- Archival tumor tissue comprising muscle-invasive urothelial carcinoma or a biopsy of
metastatic urothelial carcinoma must be provided for PD-L1 testing prior to
randomization
- Eastern Cooperative Oncology Group (ECOG) Performance Status score of 0, 1, or 2
- Adequate hematologic and organ function
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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
- Previously received enfortumab vedotin or other monomethyl auristatin E (MMAE)-based
antibody-drug conjugate (ADCs)
- Received prior treatment with a programmed cell death ligand-1 (PD-(L)-1) inhibitor
for any malignancy, including earlier stage urothelial cancer (UC), defined as a PD-1
inhibitor or PD-L1 inhibitor
- Received prior treatment with an agent directed to another stimulatory or co
inhibitory T-cell receptor
- Received anti-cancer treatment with chemotherapy, biologics, or investigational agents
not otherwise prohibited by exclusion criterion 1-3 that is not completed 4 weeks
prior to first dose of study treatment
- Uncontrolled diabetes
- Estimated life expectancy of less than 12 weeks
- Active central nervous system (CNS) metastases
- Ongoing clinically significant toxicity associated with prior treatment that has not
resolved to = Grade 1 or returned to baseline
- Currently receiving systemic antimicrobial treatment for active infection (viral,
bacterial, or fungal) at the time of randomization. Routine antimicrobial prophylaxis
is permitted.
- Known active hepatitis B, active hepatitis C, or human immunodeficiency virus (HIV)
infection.
- History of another invasive malignancy within 3 years before the first dose of study
drug, or any evidence of residual disease from a previously diagnosed malignancy
- Documented history of a cerebral vascular event (stroke or transient ischemic attack),
unstable angina, myocardial infarction, or cardiac symptoms consistent with New York
Heart Association (NYHA) Class IV within 6 months prior to randomization
- Receipt of radiotherapy within 2 weeks prior to randomization
- Received major surgery (defined as requiring general anesthesia and >24 hour inpatient
hospitalization) within 4 weeks prior to randomization
- Known severe (= Grade 3) hypersensitivity to any enfortumab vedotin excipient
contained in the drug formulation of enfortumab vedotin
- Active keratitis or corneal ulcerations
- History of autoimmune disease that has required systemic treatment in the past 2 years
- History of idiopathic pulmonary fibrosis, organizing pneumonia, drug induced
pneumonitis, idiopathic pneumonitis, or evidence of active pneumonitis on screening
chest computed tomography (CT) scan
- Prior allogeneic stem cell or solid organ transplant
- Received a live attenuated vaccine within 30 days prior to randomization
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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
Open (masking not used)
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Who is / are masked / blinded?
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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
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
30/03/2020
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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
30/09/2027
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Actual
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Sample size
Target
990
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
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Recruitment hospital [1]
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Site AU61003 - Box Hill
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Recruitment hospital [2]
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Site AUS61001 - Douglas
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Recruitment hospital [3]
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Site AUS61004 - Heidelberg
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Recruitment hospital [4]
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Site AUS61002 - Macquarie Park
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Recruitment hospital [5]
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Site AUS61006 - South Australia
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Recruitment hospital [6]
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Site AU61005 - South Brisbane
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Recruitment postcode(s) [1]
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3128 - Box Hill
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Recruitment postcode(s) [2]
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4814 - Douglas
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Recruitment postcode(s) [3]
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3084 - Heidelberg
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Recruitment postcode(s) [4]
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2109 - Macquarie Park
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Recruitment postcode(s) [5]
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5112 - South Australia
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Recruitment postcode(s) [6]
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4101 - South Brisbane
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Recruitment outside Australia
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United States of America
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Arizona
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California
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United States of America
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Colorado
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Connecticut
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District of Columbia
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Florida
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Georgia
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Louisiana
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Maine
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Maryland
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Nevada
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New Mexico
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New York
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Buenos Aire
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Caba
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Tianjin
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Xuzhou
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Brno
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Olomouc
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Praha 4-Krc
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Aalborg
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Aarhus N
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Bordeaux
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Lyon
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Nice Cedex 2
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Pierre-Bénite
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Berlin
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Germany
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Bielefeld
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Germany
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Düsseldorf
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Germany
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Erlangen
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Germany
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Essen
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Germany
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Frankfurt am Main
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Germany
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Gottingen
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Germany
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Heidelberg
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Germany
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Herne
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Germany
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Jena
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Germany
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Lubeck
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Germany
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Magdeburg
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Germany
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Mannheim
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Germany
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Munchen
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Germany
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Tübingen
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Germany
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Ulm
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Hungary
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Budapest
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Hungary
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Debrecen
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Hungary
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Nyiregyhaza
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Hungary
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Szolnok
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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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Holon
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Israel
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Jerusalem
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Israel
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Kfar Saba
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Country [101]
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Israel
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State/province [101]
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Petach Tikva
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Country [102]
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Israel
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Rehovot
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Israel
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Tel Aviv
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Israel
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Tel Hashomer
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Country [105]
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Israel
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State/province [105]
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Zerifin
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Country [106]
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Italy
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State/province [106]
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Areezo
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Country [107]
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Italy
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State/province [107]
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Candiolo
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Country [108]
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Italy
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State/province [108]
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Cremona
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Country [109]
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Italy
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State/province [109]
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Genova
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Country [110]
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Italy
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State/province [110]
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Meldola
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Country [111]
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Italy
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State/province [111]
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Milano
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Country [112]
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Italy
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State/province [112]
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Pisa
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Country [113]
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Italy
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State/province [113]
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Terni
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Country [114]
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Italy
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State/province [114]
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Torrette
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Country [115]
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Italy
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Verona
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Japan
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State/province [116]
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Bunkyo City
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Japan
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State/province [117]
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Chiba
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Country [118]
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Japan
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State/province [118]
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Fukuoka
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Country [119]
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Japan
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State/province [119]
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Hirosaki
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Country [120]
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Japan
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Kawasaki-shi
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Country [121]
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Japan
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State/province [121]
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Koto-ku
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Japan
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Kyoto
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Japan
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Niigata
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Japan
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Okayama
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Japan
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Osakasayama-Shi
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Japan
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Osaka
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Japan
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Sapporo
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Japan
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Sendai-city
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Japan
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Tokushima
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Japan
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Tokyo
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Japan
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Toyama
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Japan
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Tsukuba
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Japan
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Ube
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Country [134]
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Korea, Republic of
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Daejeon
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Korea, Republic of
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Goyang-si
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Korea, Republic of
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Hwasun
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Korea, Republic of
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Seongnam-si
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Korea, Republic of
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Seoul
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Netherlands
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Amsterdam, Noord-Holland
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Netherlands
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Amsterdam
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Netherlands
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Leeuwarden
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Netherlands
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Nieuwegein
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Netherlands
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Rotterdam
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Netherlands
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Utrecht
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Poland
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Warszawa
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Russian Federation
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Arkhangelsk
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Russian Federation
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Barnaul
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Russian Federation
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Ivanovo
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Russian Federation
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Krasnoyarsk
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Russian Federation
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Leningradskaya Oblast'
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Russian Federation
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Moscow
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Russian Federation
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Nizhniy Novgorod
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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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Russian Federation
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Saint-Petersburg
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Russian Federation
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Saransk
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Russian Federation
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St. Petersburg
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Russian Federation
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Tyumen
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Country [160]
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Russian Federation
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Ufa
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Country [161]
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Singapore
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Singapore
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Spain
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Barcelona
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Spain
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Cordoba
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Spain
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Lugo
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Spain
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Madrid
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Spain
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Manresa
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Spain
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Pamplona
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Spain
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Sabadell
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Spain
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Santander
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Spain
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Sevilla
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Spain
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Valencia
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Country [172]
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Switzerland
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Basel
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Switzerland
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Bern
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Switzerland
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Chur
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Switzerland
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Winterthur
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Taiwan
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Kaohsiung
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Taiwan
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Kweishan
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Country [178]
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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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Thailand
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Bangkok
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Thailand
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Chiang Mai
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Country [183]
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Thailand
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HatYai
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Country [184]
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Thailand
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Krung Thep Maha Nakhon
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Country [185]
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Thailand
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Muang
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Country [186]
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Thailand
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Ratchathewi
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Turkey
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Ankara
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Country [188]
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Turkey
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Antalya
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Turkey
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Edirne
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Turkey
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Istanbul
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Turkey
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Konya
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Country [192]
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Turkey
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Malatya
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Country [193]
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0
United Kingdom
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0
Glasgow
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Country [194]
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0
United Kingdom
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London
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Country [195]
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United Kingdom
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Oxford
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Country [196]
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United Kingdom
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Plymouth
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Country [197]
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United Kingdom
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State/province [197]
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Preston
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Country [198]
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United Kingdom
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0
Sheffield
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Country [199]
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0
United Kingdom
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State/province [199]
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0
Southampton
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Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
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Name
Astellas Pharma Global Development, Inc.
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Address
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Country
Query!
Other collaborator category [1]
0
0
Commercial sector/Industry
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Name [1]
0
0
Merck Sharp & Dohme LLC
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Address [1]
0
0
Query!
Country [1]
0
0
Query!
Other collaborator category [2]
0
0
Commercial sector/Industry
Query!
Name [2]
0
0
Seagen Inc.
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Address [2]
0
0
Query!
Country [2]
0
0
Query!
Ethics approval
Ethics application status
Query!
Summary
Brief summary
This study is being done to see how well two drugs (enfortumab vedotin and pembrolizumab)
work together to treat patients with urothelial cancer. The study will compare these drugs to
other drugs that are usually used to treat this cancer (standard of care). The patients in
this study will have cancer that has spread from their urinary system to other parts of their
body.
Query!
Trial website
https://clinicaltrials.gov/ct2/show/NCT04223856
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
0
0
Zejing Wang, MD, PhD
Query!
Address
0
0
Seagen Inc.
Query!
Country
0
0
Query!
Phone
0
0
Query!
Fax
0
0
Query!
Email
0
0
Query!
Contact person for public queries
Name
0
0
Seagen Inc. Trial Information Support
Query!
Address
0
0
Query!
Country
0
0
Query!
Phone
0
0
866-333-7436
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Fax
0
0
Query!
Email
0
0
[email protected]
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT04223856
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