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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT02516241
Registration number
NCT02516241
Ethics application status
Date submitted
13/07/2015
Date registered
5/08/2015
Titles & IDs
Public title
Study of MEDI4736 (Durvalumab) With or Without Tremelimumab Versus Standard of Care Chemotherapy in Urothelial Cancer
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Scientific title
A Phase III, Randomized, Open-Label, Controlled, Multi-Center, Global Study of First-Line MEDI4736 (Durvalumab) Monotherapy and MEDI4736 (Durvalumab) in Combination With Tremelimumab Versus Standard of Care Chemotherapy in Patients With Unresectable Stage IV Urothelial Cancer
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Secondary ID [1]
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2015-001633-24
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Secondary ID [2]
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D419BC00001
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Urothelial Cancer
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0
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Condition category
Condition code
Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Drugs - MEDI4736 (Durvalumab)
Treatment: Drugs - Tremelimumab
Treatment: Drugs - Cisplatin
Treatment: Drugs - Carboplatin
Treatment: Drugs - Gemcitabine
Experimental: Combination Therapy - MEDI4736 (Durvalumab) + Tremelimumab
Experimental: Monotherapy - MEDI4736 (Durvalumab)
Active comparator: Standard of Care - Standard of Care Chemotherapy Treatment
Treatment: Drugs: MEDI4736 (Durvalumab)
IV infusion
Treatment: Drugs: Tremelimumab
IV infusion
Treatment: Drugs: Cisplatin
IV infusion
Treatment: Drugs: Carboplatin
IV infusion
Treatment: Drugs: Gemcitabine
IV infusion
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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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To Assess the Efficacy of Durvalumab + Tremelimumab Combination Therapy Versus SoC in Terms of OS in Full Analysis Set
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Assessment method [1]
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The OS was defined as the time from the date of randomization until death due to any cause (ie, date of death or censoring - date of randomization + 1). Any participant not known to have died at the time of analysis were censored based on the last recorded date on which the participant was known to be alive. Median OS was calculated using the Kaplan-Meier technique.
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Timepoint [1]
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From randomization date until death due to any cause, assessed up to the data cut-off date (27JAN2020, a maximum of 5 years).
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Primary outcome [2]
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To Assess the Efficacy of Durvalumab Monotherapy Versus SoC in Terms of OS in PD-L1-High Analysis Set
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Assessment method [2]
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The OS was defined as the time from the date of randomization until death due to any cause (ie, date of death or censoring - date of randomization + 1). Any participant not known to have died at the time of analysis were censored based on the last recorded date on which the participant was known to be alive. Median OS was calculated using the Kaplan-Meier technique.
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Timepoint [2]
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0
From randomization date until death due to any cause, assessed up to the data cut-off date (27JAN2020, a maximum of 5 years).
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Secondary outcome [1]
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OS, Full Analysis Set - Durvalumab Monotherapy vs SoC
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Assessment method [1]
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The OS was defined as the time from the date of randomization until death due to any cause (ie, date of death or censoring - date of randomization + 1). Any participant not known to have died at the time of analysis were censored based on the last recorded date on which the participant was known to be alive. Median OS was calculated using the Kaplan-Meier technique.
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Timepoint [1]
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From randomization date until death due to any cause, assessed up to the data cut-off date (27JAN2020, a maximum of 5 years).
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Secondary outcome [2]
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OS, PD-L1-High Analysis Set -Durvalumab + Tremelimumab Combination Therapy Versus SoC
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Assessment method [2]
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The OS was defined as the time from the date of randomization until death due to any cause (ie, date of death or censoring - date of randomization + 1). Any participant not known to have died at the time of analysis were censored based on the last recorded date on which the participant was known to be alive. Median OS was calculated using the Kaplan-Meier technique.
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Timepoint [2]
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From randomization date until death due to any cause, assessed up to the data cut-off date (27JAN2020, a maximum of 5 years).
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Secondary outcome [3]
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OS, PD-L1-Low/Negative Analysis Set -Durvalumab + Tremelimumab Combination Therapy Versus SoC and Durvalumab + Tremelimumab Combination Therapy Versus Durvalumab Monotherapy
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Assessment method [3]
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The OS was defined as the time from the date of randomization until death due to any cause (ie, date of death or censoring - date of randomization + 1). Any participant not known to have died at the time of analysis were censored based on the last recorded date on which the participant was known to be alive. Median OS was calculated using the Kaplan-Meier technique.
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Timepoint [3]
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From randomization date until death due to any cause, assessed up to the data cut-off date (27JAN2020, a maximum of 5 years).
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Secondary outcome [4]
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Alive at 24 Months (OS24), Full Analysis Set
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Assessment method [4]
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Alive at 24 months (OS24) is defined as the Kaplan-Meier estimate of OS at 24 months.
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Timepoint [4]
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From randomization date until death due to any cause, assessed up to 24 months or the data cut-off date (27JAN2020).
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Secondary outcome [5]
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Alive at 24 Months (OS24), PD-L1-High Analysis Set
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Assessment method [5]
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Alive at 24 months (OS24) is defined as the Kaplan-Meier estimate of OS at 24 months.
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Timepoint [5]
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From randomization date until death due to any cause, assessed up to 24 months or the data cut-off date (27JAN2020).
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Secondary outcome [6]
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Alive at 24 Months (OS24), PD-L1-Low/Negative Analysis Set
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Assessment method [6]
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Alive at 24 months (OS24) is defined as the Kaplan-Meier estimate of OS at 24 months.
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Timepoint [6]
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From randomization date until death due to any cause, assessed up to 24 months or the data cut-off date (27JAN2020).
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Secondary outcome [7]
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PFS, Full Analysis Set -Durvalumab + Tremelimumab Combination Therapy vs SoC and Durvalumab Mono Therapy vs SoC
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Assessment method [7]
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Progression free survival (PFS) (per RECIST 1.1, as assessed by investigator) was defined as the time from the date of randomization until the date of objective disease progression or death (by any cause in the absence of progression) regardless of whether the patient withdraws from randomized therapy or receives another anticancer therapy prior to progression.
Median PFS was calculated using the Kaplan-Meier technique.
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Timepoint [7]
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Tumour scans performed at baseline then every 8 weeks since randomization until confirmed disease progression. Assessed up to the data cut-off date (27JAN2020, a maximum of 5 years).
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Secondary outcome [8]
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PFS, PD-L1-High Analysis Set -Durvalumab + Tremelimumab Combination Therapy vs SoC and Durvalumab Monotherapy vs SoC
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Assessment method [8]
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Progression free survival (PFS) (per RECIST 1.1, as assessed by investigator) was defined as the time from the date of randomization until the date of objective disease progression or death (by any cause in the absence of progression) regardless of whether the patient withdraws from randomized therapy or receives another anticancer therapy prior to progression.
Median PFS was calculated using the Kaplan-Meier technique.
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Timepoint [8]
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Tumour scans performed at baseline then every 8 weeks since randomization until confirmed disease progression. Assessed up to the data cut-off date (27JAN2020, a maximum of 5 years).
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Secondary outcome [9]
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PFS, PD-L1-Low/Negative Analysis Set -Durvalumab + Tremelimumab Combination Therapy Versus SoC and Durvalumab + Tremelimumab Combination Therapy Versus Durvalumab Monotherapy
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Assessment method [9]
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0
Progression free survival (PFS) (per RECIST 1.1, as assessed by investigator) was defined as the time from the date of randomization until the date of objective disease progression or death (by any cause in the absence of progression) regardless of whether the patient withdraws from randomized therapy or receives another anticancer therapy prior to progression.
Median PFS was calculated using the Kaplan-Meier technique.
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Timepoint [9]
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0
Tumour scans performed at baseline then every 8 weeks since randomization until confirmed disease progression. Assessed up to the data cut-off date (27JAN2020, a maximum of 5 years).
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Secondary outcome [10]
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Alive and Progression-free at 12 Months (APF12), Full Analysis Set
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Assessment method [10]
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Alive and progression-free at 12 months (APF12) was defined as the Kaplan-Meier estimate of PFS (per RECIST 1.1 as assessed by investigator) at 12 months.
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Timepoint [10]
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Tumour scans performed at baseline then every 8 weeks since randomization until confirmed disease progression. Assessed up to 12 months or the data cut-off date (27JAN2020).
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Secondary outcome [11]
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Alive and Progression-free at 12 Months (APF12), PD-L1-High Analysis Set
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Assessment method [11]
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Alive and progression-free at 12 months (APF12) was defined as the Kaplan-Meier estimate of PFS (per RECIST 1.1 as assessed by investigator) at 12 months.
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Timepoint [11]
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Tumour scans performed at baseline then every 8 weeks since randomization until confirmed disease progression. Assessed up to 12 months or the data cut-off date (27JAN2020).
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Secondary outcome [12]
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Alive and Progression-free at 12 Months (APF12), PD-L1-Low/Negative Analysis Set
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Assessment method [12]
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Alive and progression-free at 12 months (APF12) was defined as the Kaplan-Meier estimate of PFS (per RECIST 1.1 as assessed by investigator) at 12 months.
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Timepoint [12]
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0
Tumour scans performed at baseline then every 8 weeks since randomization until confirmed disease progression. Assessed up to 12 months or the data cut-off date (27JAN2020).
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Secondary outcome [13]
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PFS2, Full Analysis Set -Durvalumab + Tremelimumab Combination Therapy vs SoC and Durvalumab Mono Therapy vs SoC
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Assessment method [13]
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Time from randomization to second progression or death (PFS2) was defined as the time from the date of randomization to the earliest of the progression event subsequent to first subsequent therapy or death (ie, date of PFS2 event or censoring - date of randomization +1).
Median PFS2 was calculated using the Kaplan-Meier technique.
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Timepoint [13]
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0
Tumour scans performed at baseline then every 8 weeks since randomization until first confirmed disease progression, disease then assessed per local practice until 2nd progression. Assessed up to the data cut-off date (27JAN2020, a maximum of 5 years).
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Secondary outcome [14]
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PFS2, PD-L1-High Analysis Set -Durvalumab + Tremelimumab Combination Therapy vs SoC and Durvalumab Monotherapy vs SoC
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Assessment method [14]
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0
Time from randomization to second progression or death (PFS2) was defined as the time from the date of randomization to the earliest of the progression event subsequent to first subsequent therapy or death (ie, date of PFS2 event or censoring - date of randomization +1).
Median PFS2 was calculated using the Kaplan-Meier technique.
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Timepoint [14]
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0
Tumour scans performed at baseline then every 8 weeks since randomization until first confirmed disease progression, disease then assessed per local practice until 2nd progression. Assessed up to the data cut-off date (27JAN2020, a maximum of 5 years).
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Secondary outcome [15]
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0
PFS2, PD-L1-Low/Negative Analysis Set -Durvalumab + Tremelimumab Combination Therapy Versus SoC and Durvalumab + Tremelimumab Combination Therapy Versus Durvalumab Monotherapy
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Assessment method [15]
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0
Time from randomization to second progression or death (PFS2) was defined as the time from the date of randomization to the earliest of the progression event subsequent to first subsequent therapy or death (ie, date of PFS2 event or censoring - date of randomization +1).
Median PFS2 was calculated using the Kaplan-Meier technique.
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Timepoint [15]
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0
Tumour scans performed at baseline then every 8 weeks since randomization until first confirmed disease progression, disease then assessed per local practice until 2nd progression. Assessed up to the data cut-off date (27JAN2020, a maximum of 5 years).
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Secondary outcome [16]
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Objective Response Rate (ORR), Full Analysis Set -Durvalumab + Tremelimumab Combination Therapy vs SoC and Durvalumab Mono Therapy vs SoC
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Assessment method [16]
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Objective response rate ORR (per RECIST 1.1 as assessed by investigator) is defined as the number (%) of patients with at least 1 visit response of CR or PR.
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Timepoint [16]
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0
Tumour scans performed at baseline then every 8 weeks since randomization until confirmed disease progression. Assessed up to the data cut-off date (27JAN2020, a maximum of 5 years).
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Secondary outcome [17]
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0
Objective Response Rate (ORR), PD-L1-High Analysis Set -Durvalumab + Tremelimumab Combination Therapy vs SoC and Durvalumab Monotherapy vs SoC
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Assessment method [17]
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Objective response rate ORR (per RECIST 1.1 as assessed by investigator) is defined as the number (%) of patients with at least 1 visit response of CR or PR.
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Timepoint [17]
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0
Tumour scans performed at baseline then every 8 weeks since randomization until confirmed disease progression. Assessed up to the data cut-off date (27JAN2020, a maximum of 5 years).
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Secondary outcome [18]
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0
Objective Response Rate (ORR), PD-L1-Low/Negative Analysis Set -Durvalumab + Tremelimumab Combination Therapy Versus SoC and Durvalumab + Tremelimumab Combination Therapy Versus Durvalumab Monotherapy
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Assessment method [18]
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0
Objective response rate ORR (per RECIST 1.1 as assessed by investigator) is defined as the number (%) of patients with at least 1 visit response of CR or PR.
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Timepoint [18]
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0
Tumour scans performed at baseline then every 8 weeks since randomization until confirmed disease progression. Assessed up to the data cut-off date (27JAN2020, a maximum of 5 years).
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Secondary outcome [19]
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Objective Response Rate (ORR) Based on BICR Assessment According to RECIST 1.1 - Responses Are Confirmed - Durvalumab Cisplatin Ineligible Population
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Assessment method [19]
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Objective response rate ORR (per RECIST 1.1 as assessed by investigator) is defined as the number (%) of patients with at least 1 visit response of CR or PR.
unconfirmed responses are excluded.
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Timepoint [19]
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0
Tumour scans performed at baseline then every 8 weeks since randomization until confirmed disease progression. Assessed up to the data cut-off date (01NOV2017, a maximum of 3 years).
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Secondary outcome [20]
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Disease Control Rate (DCR) at 6 Months, Full Analysis Set -Durvalumab + Tremelimumab Combination Therapy vs SoC and Durvalumab Mono Therapy vs SoC
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Assessment method [20]
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Disease control rate (DCR) at 6 months is defined as the percentage of patients who have a best objective response (BoR) of CR or PR, or who have demonstrated SD for a minimum interval of 24 weeks (-7 days, i.e., 161 days), following the start of study treatment.
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Timepoint [20]
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0
Tumour scans performed at baseline then every 8 weeks since randomization until confirmed disease progression. Assessed up to 6 months or the data cut-off date (27JAN2020).
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Secondary outcome [21]
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Disease Control Rate (DCR) at 6 Months, PD-L1-High Analysis Set -Durvalumab + Tremelimumab Combination Therapy vs SoC and Durvalumab Monotherapy vs SoC
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Assessment method [21]
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Disease control rate (DCR) at 6 months is defined as the percentage of patients who have a best objective response (BoR) of CR or PR, or who have demonstrated SD for a minimum interval of 24 weeks (-7 days, i.e., 161 days), following the start of study treatment.
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Timepoint [21]
0
0
Tumour scans performed at baseline then every 8 weeks since randomization until confirmed disease progression. Assessed up to 6 months or the data cut-off date (27JAN2020).
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Secondary outcome [22]
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0
Disease Control Rate (DCR) at 6 Months, PD-L1-Low/Negative Analysis Set -Durvalumab + Tremelimumab Combination Therapy Versus SoC and Durvalumab + Tremelimumab Combination Therapy Versus Durvalumab Monotherapy
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Assessment method [22]
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Disease control rate (DCR) at 6 months is defined as the percentage of patients who have a best objective response (BoR) of CR or PR, or who have demonstrated SD for a minimum interval of 24 weeks (-7 days, i.e., 161 days), following the start of study treatment.
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Timepoint [22]
0
0
Tumour scans performed at baseline then every 8 weeks since randomization until confirmed disease progression. Assessed up to 6 months or the data cut-off date (27JAN2020).
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Secondary outcome [23]
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0
Disease Control Rate (DCR) at 12 Months, Full Analysis Set -Durvalumab + Tremelimumab Combination Therapy vs SoC and Durvalumab Mono Therapy vs SoC
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Assessment method [23]
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0
Disease control rate (DCR) at 12 months is defined as the percentage of patients who have a best objective response (BoR) of CR or PR, or who have demonstrated SD for a minimum interval of 48 weeks (-7 days, i.e., 329 days), following the start of study treatment.
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Timepoint [23]
0
0
Tumour scans performed at baseline then every 8 weeks since randomization until confirmed disease progression. Assessed up to 12 months or the data cut-off date (27JAN2020)
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Secondary outcome [24]
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0
Disease Control Rate (DCR) at 12 Months, PD-L1-High Analysis Set -Durvalumab + Tremelimumab Combination Therapy vs SoC and Durvalumab Monotherapy vs SoC
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Assessment method [24]
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0
Disease control rate (DCR) at 12 months is defined as the percentage of patients who have a best objective response (BoR) of CR or PR, or who have demonstrated SD for a minimum interval of 48 weeks (-7 days, i.e., 329 days), following the start of study treatment.
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Timepoint [24]
0
0
Tumour scans performed at baseline then every 8 weeks since randomization until confirmed disease progression. Assessed up to 12 months or the data cut-off date (27JAN2020).
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Secondary outcome [25]
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0
Disease Control Rate (DCR) at 12 Months, PD-L1-Low/Negative Analysis Set -Durvalumab + Tremelimumab Combination Therapy Versus SoC and Durvalumab + Tremelimumab Combination Therapy Versus Durvalumab Monotherapy
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Assessment method [25]
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0
Disease control rate (DCR) at 12 months is defined as the percentage of patients who have a best objective response (BoR) of CR or PR, or who have demonstrated SD for a minimum interval of 48 weeks (-7 days, i.e., 329 days), following the start of study treatment.
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Timepoint [25]
0
0
Tumour scans performed at baseline then every 8 weeks since randomization until confirmed disease progression. Assessed up to 12 months or the data cut-off date (27JAN2020).
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Secondary outcome [26]
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0
Duration of Response (DoR), Full Analysis Set
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Assessment method [26]
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0
Duration of response (DoR) (per RECIST 1.1 as assessed by investigator) was defined as the time from the date of first documented response until the first date of documented progression or death in the absence of disease progression (i.e. date of PFS event or censoring - date of first response + 1).
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Timepoint [26]
0
0
Tumour scans performed at baseline then every 8 weeks since randomization until confirmed disease progression. Assessed up to the data cut-off date (27JAN2020, a maximum of 5 years).
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Secondary outcome [27]
0
0
Duration of Response (DoR), PD-L1-High Analysis Set
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Assessment method [27]
0
0
Duration of response (DoR) (per RECIST 1.1 as assessed by investigator) was defined as the time from the date of first documented response until the first date of documented progression or death in the absence of disease progression (i.e. date of PFS event or censoring - date of first response + 1).
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Timepoint [27]
0
0
Tumour scans performed at baseline then every 8 weeks since randomization until confirmed disease progression. Assessed up to the data cut-off date (27JAN2020, a maximum of 5 years).
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Secondary outcome [28]
0
0
Duration of Response (DoR), PD-L1-Low/Negative Analysis Set
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Assessment method [28]
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0
Duration of response (DoR) (per RECIST 1.1 as assessed by investigator) was defined as the time from the date of first documented response until the first date of documented progression or death in the absence of disease progression (i.e. date of PFS event or censoring - date of first response + 1).
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Timepoint [28]
0
0
Tumour scans performed at baseline then every 8 weeks since randomization until confirmed disease progression. Assessed up to the data cut-off date (27JAN2020, a maximum of 5 years).
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Secondary outcome [29]
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0
Serum Concentrations of Durvalumab, Pharmacokinetic Analysis Set
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Assessment method [29]
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0
Blood samples were collected to determine the serum concentration of durvalumab.
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Timepoint [29]
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0
Pre-dose and within 1 hour after end of infusion at Week 0, 12 and 24, pre-dose at week 4, and at follow-up Month 3.
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Secondary outcome [30]
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0
Serum Concentrations of Tremelimumab, Pharmacokinetic Analysis Set
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Assessment method [30]
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0
Blood samples were collected to determine the serum concentration of tremelimumab.
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Timepoint [30]
0
0
Pre-dose and within 1 hour after end of infusion at Week 0, 12 and 24, pre-dose at week 4, and at follow-up Month 3.
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Secondary outcome [31]
0
0
Number of Participants With Anti-Drug Antibody (ADA) Response to Durvalumab, Safety Analysis Set - ADA Evaluable Patients
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Assessment method [31]
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0
Serum Samples will be measured for the presence of ADAs and ADA-neutralizing antibodies for Durvalumab using validated assays. Tiered analysis will be performed to include screening, confirmatory, and titer assay components, and positive-negative cut points previously statistically determined from drug-naïve validation samples will be used. Persistently positive is defined as having at least 2 post-baseline ADA positive measurements with at least 16 weeks (112 days) between the first and last positive measurements, or an ADA positive result at the last available assessment. Transiently positive is defined as having at least one post-baseline ADA positive measurement and not fulfilling the conditions for persistently positive. The category may include patients meeting these criteria who are ADA positive at baseline.
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Timepoint [31]
0
0
At week 0, 4, 12 and 24, and at follow-up Month 3.
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Secondary outcome [32]
0
0
Number of Participants With Anti-Drug Antibody (ADA) Response to Tremelimumab, Safety Analysis Set - ADA Evaluable Patients
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Assessment method [32]
0
0
Serum Samples will be measured for the presence of ADAs and ADA-neutralizing antibodies for Tremelimumab using validated assays. Tiered analysis will be performed to include screening, confirmatory, and titer assay components, and positive-negative cut points previously statistically determined from drug-naïve validation samples will be used. Persistently positive is defined as having at least 2 post-baseline ADA positive measurements with at least 16 weeks (112 days) between the first and last positive measurements, or an ADA positive result at the last available assessment. Transiently positive is defined as having at least one post-baseline ADA positive measurement and not fulfilling the conditions for persistently positive. The category may include patients meeting these criteria who are ADA positive at baseline.
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Timepoint [32]
0
0
At week 0, 4, 12 and at follow-up Month 3.
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Secondary outcome [33]
0
0
Change From Baseline in FACT-BL (Derived NFBlSI-18 Score, FACT-BL TOI, and FACT-BL Total Score) by MMRM Analysis, Full Analysis Set -Durvalumab + Tremelimumab Combination Therapy vs SoC and Durvalumab Mono Therapy vs SoC
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Assessment method [33]
0
0
the change from baseline in the following total/index scores will be evaluated as secondary endpoints: FACT-BL TOI (refer to as TOI), FACT-BL Total score, and NFBlSI-18 score.
All the 5 subscales (PWB (0-28), FWB (0-28), EWB (0-24), SWB (0-28), and BlCS(0-48)) are summed as the FACT-BL total score (range 0-156), while the sum of PWB, FWB and BICS constitutes the FACT-BL TOI (range 0-104).
NFBlSI-18 (range 0-72) is based on the scores of 16 items (GP4, C2, BL1, GP3, GE6, GE1, C6, BL5, GF5, GP2, GP1, GP6, C3, GP5, GF3, GF7) and 2 extra items "I feel weak all overall" and "I feel light-headed (dizzy)". The range of each item is 0-4.
Higher score represent worse outcome.
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Timepoint [33]
0
0
At baseline then every 8 weeks until second progression/death, whichever comes first. Assessed up to the data cut-off date (27JAN2020, a maximum of 5 years).
Query!
Secondary outcome [34]
0
0
Change From Baseline in FACT-BL (Derived NFBlSI-18 Score, FACT-BL TOI, and FACT-BL Total Score) by MMRM Analysis, PD-L1-High Analysis Set -Durvalumab + Tremelimumab Combination Therapy vs SoC and Durvalumab Mono Therapy vs SoC
Query!
Assessment method [34]
0
0
the change from baseline in the following total/index scores will be evaluated as secondary endpoints: FACT-BL TOI (refer to as TOI), FACT-BL Total score, and NFBlSI-18 score.
All the 5 subscales (PWB (0-28), FWB (0-28), EWB (0-24), SWB (0-28), and BlCS(0-48)) are summed as the FACT-BL total score (range 0-156), while the sum of PWB, FWB and BICS constitutes the FACT-BL TOI (range 0-104).
NFBlSI-18 (range 0-72) is based on the scores of 16 items (GP4, C2, BL1, GP3, GE6, GE1, C6, BL5, GF5, GP2, GP1, GP6, C3, GP5, GF3, GF7) and 2 extra items "I feel weak all overall" and "I feel light-headed (dizzy)". The range of each item is 0-4.
Higher score represent worse
Query!
Timepoint [34]
0
0
At baseline then every 8 weeks until second progression/death, whichever comes first. Assessed up to the data cut-off date (27JAN2020, a maximum of 5 years).
Query!
Secondary outcome [35]
0
0
Change From Baseline in FACT-BL (Derived NFBlSI-18 Score, FACT-BL TOI, and FACT-BL Total Score) by MMRM Analysis, PD-L1-Low/Negative Analysis Set -Durvalumab + Tremelimumab Combination Therapy vs SoC and Durvalumab Mono Therapy vs SoC
Query!
Assessment method [35]
0
0
the change from baseline in the following total/index scores will be evaluated as secondary endpoints: FACT-BL TOI (refer to as TOI), FACT-BL Total score, and NFBlSI-18 score.
All the 5 subscales (PWB (0-28), FWB (0-28), EWB (0-24), SWB (0-28), and BlCS(0-48)) are summed as the FACT-BL total score (range 0-156), while the sum of PWB, FWB and BICS constitutes the FACT-BL TOI (range 0-104).
NFBlSI-18 (range 0-72) is based on the scores of 16 items (GP4, C2, BL1, GP3, GE6, GE1, C6, BL5, GF5, GP2, GP1, GP6, C3, GP5, GF3, GF7) and 2 extra items "I feel weak all overall" and "I feel light-headed (dizzy)". The range of each item is 0-4.
Higher score represent worse
Query!
Timepoint [35]
0
0
At baseline then every 8 weeks until second progression/death, whichever comes first. Assessed up to the data cut-off date (27JAN2020, a maximum of 5 years).
Query!
Secondary outcome [36]
0
0
Improvement in Fatigue and Deterioration in Pain Per FACT-BL, Full Analysis Set -Durvalumab + Tremelimumab Combination Therapy vs SoC and Durvalumab Mono Therapy vs SoC
Query!
Assessment method [36]
0
0
Fatigue will be based on the question of "I have a lack of energy" and pain will be based on the question of "I have pain", according to GP1 and GP4 in PWB, respectively.
Improvement in fatigue is defined at least 1 point improvement from baseline using GP1 of FACT-BL.
Deterioration in pain is defined as at least 1 point deterioration from baseline using GP4 of FACT-BL.
Query!
Timepoint [36]
0
0
At baseline then every 8 weeks until second progression/death, whichever comes first. Assessed up to the data cut-off date (27JAN2020, a maximum of 5 years).
Query!
Secondary outcome [37]
0
0
Improvement in Fatigue and Deterioration in Pain Per FACT-BL, PD-L1-High Analysis Set -Durvalumab + Tremelimumab Combination Therapy vs SoC and Durvalumab Mono Therapy vs SoC
Query!
Assessment method [37]
0
0
Fatigue will be based on the question of "I have a lack of energy" and pain will be based on the question of "I have pain", according to GP1 and GP4 in PWB, respectively.
Improvement in fatigue is defined at least 1 point improvement from baseline using GP1 of FACT-BL.
Deterioration in pain is defined as at least 1 point deterioration from baseline using GP4 of FACT-BL.
Query!
Timepoint [37]
0
0
At baseline then every 8 weeks until second progression/death, whichever comes first. Assessed up to the data cut-off date (27JAN2020, a maximum of 5 years).
Query!
Secondary outcome [38]
0
0
Improvement in Fatigue and Deterioration in Pain Per FACT-BL, PD-L1-Low/Negative Analysis Set -Durvalumab + Tremelimumab Combination Therapy vs SoC and Durvalumab Mono Therapy vs SoC
Query!
Assessment method [38]
0
0
Fatigue will be based on the question of "I have a lack of energy" and pain will be based on the question of "I have pain", according to GP1 and GP4 in PWB, respectively.
Improvement in fatigue is defined at least 1 point improvement from baseline using GP1 of FACT-BL.
Deterioration in pain is defined as at least 1 point deterioration from baseline using GP4 of FACT-BL.
Query!
Timepoint [38]
0
0
At baseline then every 8 weeks until second progression/death, whichever comes first. Assessed up to the data cut-off date (27JAN2020, a maximum of 5 years).
Query!
Eligibility
Key inclusion criteria
* Patients with histologically or cytologically documented, unresectable, Stage IV transitional cell carcinoma of the urothelium who have not been previously treated with first-line chemotherapy.
* Patients eligible or ineligible for cisplatin-based chemotherapy. Cisplatin ineligibility is defined as meeting 1 of the following criteria: • Creatinine clearance (calculated or measured) <60 mL/min calculated by Cockcroft-Gault equation (using actual body weight) or by measured 24-hour urine collection for determination • Common Terminology Criteria for Adverse Events (CTCAE) Grade =2 audiometric hearing loss • CTCAE Grade =2 peripheral neuropathy • New York Heart Association =Class III heart failure.
* Tumor PD-L1 status, with Immunohistochemical (IHC) assay confirmed by a reference laboratory, must be known prior to randomization.
Query!
Minimum age
18
Years
Query!
Query!
Maximum age
130
Years
Query!
Query!
Sex
Both males and females
Query!
Can healthy volunteers participate?
No
Query!
Key exclusion criteria
* Prior exposure to immune-mediated therapy, including but not limited to, other anti cytotoxic T-lymphocyte-associated protein 4 (CTLA 4), anti-PD-1, anti-PD-L1, or anti-PD-L2 antibodies, including therapeutic anticancer vaccines. Prior local intervesical chemotherapy or immunotherapy is allowed if completed at least 28 days prior to the initiation of study treatment.
* History of allogenic organ transplantation that requires use of immunosuppressive agents.
* Active or prior documented autoimmune or inflammatory disorders. The following are exceptions to this criterion: • Patients with vitiligo or alopecia • Patients with hypothyroidism (eg, following Hashimoto syndrome) stable on hormone replacement • Any chronic skin condition that does not require systemic therapy • Patients without active disease in the last 3 years may be included but only after consultation with AstraZeneca • Patients with celiac disease controlled by diet alone may be included but only after consultation with AstraZeneca.
* Brain metastases or spinal cord compression unless the patient's condition is stable and off steroids for at least 14 days prior to the start of study treatment. Patients with suspected or known brain metastases at screening should have an MRI (preferred)/CT, preferably with IV contrast to access baseline disease status.
* Active infection including tuberculosis, hepatitis B, hepatitis C, or human immunodeficiency virus (HIV).
* Current or prior use of immunosuppressive medication within 14 days before the first dose of investigational product (IP). The following are exceptions to this criterion: • Intranasal, inhaled, topical steroids, or local steroid injections (eg, intra articular injection) • Systemic corticosteroids at physiologic doses not to exceed 10 mg/day of prednisone or its equivalent • Steroids as premedication for hypersensitivity reactions (eg, CT scan premedication).
* Receipt of live attenuated vaccine within 30 days prior to the first dose of IP. Note: Patients, if enrolled, should not receive live vaccine during the study and up to 30 days after the last dose of IP.
Query!
Study design
Purpose of the study
Treatment
Query!
Allocation to intervention
Randomised controlled trial
Query!
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Query!
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Query!
Masking / blinding
Open (masking not used)
Query!
Who is / are masked / blinded?
Query!
Query!
Query!
Query!
Intervention assignment
Parallel
Query!
Other design features
Query!
Phase
Phase 3
Query!
Type of endpoint/s
Query!
Statistical methods / analysis
Query!
Recruitment
Recruitment status
Active, not recruiting
Query!
Data analysis
Query!
Reason for early stopping/withdrawal
Query!
Other reasons
Query!
Date of first participant enrolment
Anticipated
Query!
Actual
2/11/2015
Query!
Date of last participant enrolment
Anticipated
Query!
Actual
Query!
Date of last data collection
Anticipated
30/12/2024
Query!
Actual
Query!
Sample size
Target
Query!
Accrual to date
Query!
Final
1126
Query!
Recruitment in Australia
Recruitment state(s)
Query!
Recruitment hospital [1]
0
0
Research Site - Box Hill
Query!
Recruitment hospital [2]
0
0
Research Site - Elizabeth Vale
Query!
Recruitment hospital [3]
0
0
Research Site - Macquarie University
Query!
Recruitment hospital [4]
0
0
Research Site - St Leonards
Query!
Recruitment hospital [5]
0
0
Research Site - Waratah
Query!
Recruitment postcode(s) [1]
0
0
3128 - Box Hill
Query!
Recruitment postcode(s) [2]
0
0
5112 - Elizabeth Vale
Query!
Recruitment postcode(s) [3]
0
0
2109 - Macquarie University
Query!
Recruitment postcode(s) [4]
0
0
2065 - St Leonards
Query!
Recruitment postcode(s) [5]
0
0
2298 - Waratah
Query!
Recruitment outside Australia
Country [1]
0
0
United States of America
Query!
State/province [1]
0
0
California
Query!
Country [2]
0
0
United States of America
Query!
State/province [2]
0
0
Colorado
Query!
Country [3]
0
0
United States of America
Query!
State/province [3]
0
0
Connecticut
Query!
Country [4]
0
0
United States of America
Query!
State/province [4]
0
0
Florida
Query!
Country [5]
0
0
United States of America
Query!
State/province [5]
0
0
Georgia
Query!
Country [6]
0
0
United States of America
Query!
State/province [6]
0
0
Kentucky
Query!
Country [7]
0
0
United States of America
Query!
State/province [7]
0
0
Massachusetts
Query!
Country [8]
0
0
United States of America
Query!
State/province [8]
0
0
Michigan
Query!
Country [9]
0
0
United States of America
Query!
State/province [9]
0
0
Nebraska
Query!
Country [10]
0
0
United States of America
Query!
State/province [10]
0
0
New York
Query!
Country [11]
0
0
United States of America
Query!
State/province [11]
0
0
Tennessee
Query!
Country [12]
0
0
United States of America
Query!
State/province [12]
0
0
Washington
Query!
Country [13]
0
0
Austria
Query!
State/province [13]
0
0
Linz
Query!
Country [14]
0
0
Austria
Query!
State/province [14]
0
0
Wien
Query!
Country [15]
0
0
Belgium
Query!
State/province [15]
0
0
Brussels
Query!
Country [16]
0
0
Belgium
Query!
State/province [16]
0
0
Bruxelles
Query!
Country [17]
0
0
Belgium
Query!
State/province [17]
0
0
Leuven
Query!
Country [18]
0
0
Belgium
Query!
State/province [18]
0
0
Liège
Query!
Country [19]
0
0
Brazil
Query!
State/province [19]
0
0
Barretos
Query!
Country [20]
0
0
Brazil
Query!
State/province [20]
0
0
Belo Horizonte
Query!
Country [21]
0
0
Brazil
Query!
State/province [21]
0
0
Ijui
Query!
Country [22]
0
0
Brazil
Query!
State/province [22]
0
0
Itajai
Query!
Country [23]
0
0
Brazil
Query!
State/province [23]
0
0
Porto Alegre
Query!
Country [24]
0
0
Brazil
Query!
State/province [24]
0
0
Rio de Janeiro
Query!
Country [25]
0
0
Brazil
Query!
State/province [25]
0
0
Sao Paulo
Query!
Country [26]
0
0
Brazil
Query!
State/province [26]
0
0
São José do Rio Preto
Query!
Country [27]
0
0
Canada
Query!
State/province [27]
0
0
Alberta
Query!
Country [28]
0
0
Canada
Query!
State/province [28]
0
0
British Columbia
Query!
Country [29]
0
0
Canada
Query!
State/province [29]
0
0
Nova Scotia
Query!
Country [30]
0
0
Canada
Query!
State/province [30]
0
0
Ontario
Query!
Country [31]
0
0
Canada
Query!
State/province [31]
0
0
Quebec
Query!
Country [32]
0
0
China
Query!
State/province [32]
0
0
Beijing
Query!
Country [33]
0
0
China
Query!
State/province [33]
0
0
Changchun
Query!
Country [34]
0
0
China
Query!
State/province [34]
0
0
Changsha
Query!
Country [35]
0
0
China
Query!
State/province [35]
0
0
Chongqing
Query!
Country [36]
0
0
China
Query!
State/province [36]
0
0
Hangzhou
Query!
Country [37]
0
0
China
Query!
State/province [37]
0
0
Nanjing
Query!
Country [38]
0
0
China
Query!
State/province [38]
0
0
Shanghai
Query!
Country [39]
0
0
China
Query!
State/province [39]
0
0
Shenyang
Query!
Country [40]
0
0
China
Query!
State/province [40]
0
0
Tianjin
Query!
Country [41]
0
0
China
Query!
State/province [41]
0
0
Xi'an
Query!
Country [42]
0
0
China
Query!
State/province [42]
0
0
Xiamen
Query!
Country [43]
0
0
Denmark
Query!
State/province [43]
0
0
Herlev
Query!
Country [44]
0
0
Denmark
Query!
State/province [44]
0
0
København Ø
Query!
Country [45]
0
0
Denmark
Query!
State/province [45]
0
0
Odense C
Query!
Country [46]
0
0
Denmark
Query!
State/province [46]
0
0
Århus C
Query!
Country [47]
0
0
France
Query!
State/province [47]
0
0
Bordeaux
Query!
Country [48]
0
0
France
Query!
State/province [48]
0
0
Caen Cedex
Query!
Country [49]
0
0
France
Query!
State/province [49]
0
0
Lyon Cedex 08
Query!
Country [50]
0
0
France
Query!
State/province [50]
0
0
Marseille cedex 09
Query!
Country [51]
0
0
France
Query!
State/province [51]
0
0
Paris Cedex 10
Query!
Country [52]
0
0
France
Query!
State/province [52]
0
0
Poitiers Cedex
Query!
Country [53]
0
0
France
Query!
State/province [53]
0
0
Suresnes Cedex
Query!
Country [54]
0
0
France
Query!
State/province [54]
0
0
Toulouse
Query!
Country [55]
0
0
France
Query!
State/province [55]
0
0
Villejuif
Query!
Country [56]
0
0
Germany
Query!
State/province [56]
0
0
Düsseldorf
Query!
Country [57]
0
0
Germany
Query!
State/province [57]
0
0
Erlangen
Query!
Country [58]
0
0
Germany
Query!
State/province [58]
0
0
Hannover
Query!
Country [59]
0
0
Germany
Query!
State/province [59]
0
0
Heidelberg
Query!
Country [60]
0
0
Germany
Query!
State/province [60]
0
0
Jena
Query!
Country [61]
0
0
Germany
Query!
State/province [61]
0
0
München
Query!
Country [62]
0
0
Germany
Query!
State/province [62]
0
0
Münster
Query!
Country [63]
0
0
Greece
Query!
State/province [63]
0
0
Athens
Query!
Country [64]
0
0
Greece
Query!
State/province [64]
0
0
Heraklion
Query!
Country [65]
0
0
Greece
Query!
State/province [65]
0
0
Holargos, Athens
Query!
Country [66]
0
0
Greece
Query!
State/province [66]
0
0
Maroussi, Athens
Query!
Country [67]
0
0
Greece
Query!
State/province [67]
0
0
Patras
Query!
Country [68]
0
0
Greece
Query!
State/province [68]
0
0
Thessaloniki
Query!
Country [69]
0
0
Israel
Query!
State/province [69]
0
0
Haifa
Query!
Country [70]
0
0
Israel
Query!
State/province [70]
0
0
Jerusalem
Query!
Country [71]
0
0
Israel
Query!
State/province [71]
0
0
Petach-Tikva
Query!
Country [72]
0
0
Israel
Query!
State/province [72]
0
0
Ramat Gan
Query!
Country [73]
0
0
Israel
Query!
State/province [73]
0
0
Zerifin
Query!
Country [74]
0
0
Italy
Query!
State/province [74]
0
0
Arezzo
Query!
Country [75]
0
0
Italy
Query!
State/province [75]
0
0
Meldola
Query!
Country [76]
0
0
Italy
Query!
State/province [76]
0
0
Milano
Query!
Country [77]
0
0
Italy
Query!
State/province [77]
0
0
Napoli
Query!
Country [78]
0
0
Italy
Query!
State/province [78]
0
0
Orbassano
Query!
Country [79]
0
0
Italy
Query!
State/province [79]
0
0
Pavia
Query!
Country [80]
0
0
Italy
Query!
State/province [80]
0
0
Roma
Query!
Country [81]
0
0
Italy
Query!
State/province [81]
0
0
San Giovanni Rotondo
Query!
Country [82]
0
0
Japan
Query!
State/province [82]
0
0
Akita-shi
Query!
Country [83]
0
0
Japan
Query!
State/province [83]
0
0
Bunkyo-ku
Query!
Country [84]
0
0
Japan
Query!
State/province [84]
0
0
Fukuoka-shi
Query!
Country [85]
0
0
Japan
Query!
State/province [85]
0
0
Hakata-shi
Query!
Country [86]
0
0
Japan
Query!
State/province [86]
0
0
Hirosaki-shi
Query!
Country [87]
0
0
Japan
Query!
State/province [87]
0
0
Hiroshima-shi
Query!
Country [88]
0
0
Japan
Query!
State/province [88]
0
0
Izumo-shi
Query!
Country [89]
0
0
Japan
Query!
State/province [89]
0
0
Kagoshima-shi
Query!
Country [90]
0
0
Japan
Query!
State/province [90]
0
0
Kanazawa-shi
Query!
Country [91]
0
0
Japan
Query!
State/province [91]
0
0
Kita-gun
Query!
Country [92]
0
0
Japan
Query!
State/province [92]
0
0
Kobe-shi
Query!
Country [93]
0
0
Japan
Query!
State/province [93]
0
0
Koshigaya-shi
Query!
Country [94]
0
0
Japan
Query!
State/province [94]
0
0
Koto-ku
Query!
Country [95]
0
0
Japan
Query!
State/province [95]
0
0
Kumamoto-shi
Query!
Country [96]
0
0
Japan
Query!
State/province [96]
0
0
Kyoto-shi
Query!
Country [97]
0
0
Japan
Query!
State/province [97]
0
0
Matsuyama-shi
Query!
Country [98]
0
0
Japan
Query!
State/province [98]
0
0
Morioka-shi
Query!
Country [99]
0
0
Japan
Query!
State/province [99]
0
0
Nagasaki-shi
Query!
Country [100]
0
0
Japan
Query!
State/province [100]
0
0
Nagoya-shi
Query!
Country [101]
0
0
Japan
Query!
State/province [101]
0
0
Osaka-shi
Query!
Country [102]
0
0
Japan
Query!
State/province [102]
0
0
Osakasayama-shi
Query!
Country [103]
0
0
Japan
Query!
State/province [103]
0
0
Saga-shi
Query!
Country [104]
0
0
Japan
Query!
State/province [104]
0
0
Sagamihara-shi
Query!
Country [105]
0
0
Japan
Query!
State/province [105]
0
0
Sakura-shi
Query!
Country [106]
0
0
Japan
Query!
State/province [106]
0
0
Sapporo-shi
Query!
Country [107]
0
0
Japan
Query!
State/province [107]
0
0
Suita-shi
Query!
Country [108]
0
0
Japan
Query!
State/province [108]
0
0
Takatsuki-shi
Query!
Country [109]
0
0
Japan
Query!
State/province [109]
0
0
Yokohama-shi
Query!
Country [110]
0
0
Korea, Republic of
Query!
State/province [110]
0
0
Incheon
Query!
Country [111]
0
0
Korea, Republic of
Query!
State/province [111]
0
0
Seongnam-si
Query!
Country [112]
0
0
Korea, Republic of
Query!
State/province [112]
0
0
Seoul
Query!
Country [113]
0
0
Mexico
Query!
State/province [113]
0
0
Guadalajara
Query!
Country [114]
0
0
Mexico
Query!
State/province [114]
0
0
León
Query!
Country [115]
0
0
Mexico
Query!
State/province [115]
0
0
Mexico, D.F
Query!
Country [116]
0
0
Mexico
Query!
State/province [116]
0
0
Mexico
Query!
Country [117]
0
0
Mexico
Query!
State/province [117]
0
0
Monterrey
Query!
Country [118]
0
0
Mexico
Query!
State/province [118]
0
0
México
Query!
Country [119]
0
0
Netherlands
Query!
State/province [119]
0
0
Amsterdam
Query!
Country [120]
0
0
Netherlands
Query!
State/province [120]
0
0
Breda
Query!
Country [121]
0
0
Netherlands
Query!
State/province [121]
0
0
Enschede
Query!
Country [122]
0
0
Netherlands
Query!
State/province [122]
0
0
Groningen
Query!
Country [123]
0
0
Netherlands
Query!
State/province [123]
0
0
Leiden
Query!
Country [124]
0
0
Netherlands
Query!
State/province [124]
0
0
Maastricht
Query!
Country [125]
0
0
Netherlands
Query!
State/province [125]
0
0
Nijmegen
Query!
Country [126]
0
0
Poland
Query!
State/province [126]
0
0
Gdansk
Query!
Country [127]
0
0
Poland
Query!
State/province [127]
0
0
Gdynia
Query!
Country [128]
0
0
Poland
Query!
State/province [128]
0
0
Gliwice
Query!
Country [129]
0
0
Poland
Query!
State/province [129]
0
0
Olsztyn
Query!
Country [130]
0
0
Poland
Query!
State/province [130]
0
0
Otwock
Query!
Country [131]
0
0
Poland
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Szczecin
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Warszawa
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Loures
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Porto
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Russian Federation
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Saint Petersburg
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Russian Federation
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Russian Federation
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St. Petersburg
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St.Petersburg
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Russian Federation
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Ufa
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Russian Federation
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Yaroslavl
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Spain
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Badajoz
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Barcelona
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Elche(Alicante)
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Madrid
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Santiago de Compostela
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Kaohsiung
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Tainan
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Taipei
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Taiwan
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Turkey
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Ankara
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Turkey
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Edirne
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Izmir
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United Kingdom
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Cambridge
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Cardiff.
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Glasgow
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Leeds
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London
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Manchester
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Sheffield
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Southampton
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Funding & Sponsors
Primary sponsor type
Commercial sector/industry
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Name
AstraZeneca
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Ethics approval
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Summary
Brief summary
A Phase III, Randomized, Open-Label, Controlled, Multi-Center, Global Study of First-Line MEDI4736 (Durvalumab) Monotherapy and MEDI4736 (Durvalumab) in Combination with Tremelimumab Versus Standard of Care Chemotherapy in Patients with Stage IV Urothelial Cancer
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Trial website
https://clinicaltrials.gov/study/NCT02516241
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Trial related presentations / publications
Powles T, van der Heijden MS, Castellano D, Galsky MD, Loriot Y, Petrylak DP, Ogawa O, Park SH, Lee JL, De Giorgi U, Bogemann M, Bamias A, Eigl BJ, Gurney H, Mukherjee SD, Fradet Y, Skoneczna I, Tsiatas M, Novikov A, Suarez C, Fay AP, Duran I, Necchi A, Wildsmith S, He P, Angra N, Gupta AK, Levin W, Bellmunt J; DANUBE study investigators. Durvalumab alone and durvalumab plus tremelimumab versus chemotherapy in previously untreated patients with unresectable, locally advanced or metastatic urothelial carcinoma (DANUBE): a randomised, open-label, multicentre, phase 3 trial. Lancet Oncol. 2020 Dec;21(12):1574-1588. doi: 10.1016/S1470-2045(20)30541-6. Epub 2020 Sep 21. Erratum In: Lancet Oncol. 2021 Jan;22(1):e5. doi: 10.1016/S1470-2045(20)30734-8.
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Public notes
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Contacts
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Contact person for scientific queries
Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
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What data in particular will be shared?
Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal. All request will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
Supporting document/s available: Study protocol, Statistical analysis plan (SAP)
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When will data be available (start and end dates)?
AstraZeneca will meet or exceed data availability as per the commitments made to the EFPIA Pharma Data Sharing Principles. For details of our timelines, please rerefer to our disclosure commitment at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
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Available to whom?
When a request has been approved AstraZeneca will provide access to the de-identified individual patient-level data in an approved sponsored tool . Signed Data Sharing Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information. Additionally, all users will need to accept the terms and conditions of the SAS MSE to gain access. For additional details, please review the Disclosure Statements at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
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Available for what types of analyses?
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How or where can data be obtained?
IPD available at link: https://astrazenecagroup-dt.pharmacm.com/DT/Home
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What supporting documents are/will be available?
No Supporting Document Provided
Type
Other Details
Attachment
Study protocol
https://cdn.clinicaltrials.gov/large-docs/41/NCT02516241/Prot_000.pdf
Statistical analysis plan
https://cdn.clinicaltrials.gov/large-docs/41/NCT02516241/SAP_001.pdf
Results publications and other study-related documents
No documents have been uploaded by study researchers.
Results are available at
https://clinicaltrials.gov/study/NCT02516241