Trial Review

Registering a new trial?

To achieve prospective registration, we recommend submitting your trial for registration at the same time as ethics submission.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
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
Date last updated
23/10/2024

Titles & IDs
Public title
Study of MEDI4736 (Durvalumab) With or Without Tremelimumab Versus Standard of Care Chemotherapy in Urothelial Cancer
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
Secondary ID [1] 0 0
2015-001633-24
Secondary ID [2] 0 0
D419BC00001
Universal Trial Number (UTN)
Trial acronym
Linked study record

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

Intervention/exposure
Study type
Interventional
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
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
To Assess the Efficacy of Durvalumab + Tremelimumab Combination Therapy Versus SoC in Terms of OS in Full Analysis Set
Timepoint [1] 0 0
From randomization date until death due to any cause, assessed up to the data cut-off date (27JAN2020, a maximum of 5 years).
Primary outcome [2] 0 0
To Assess the Efficacy of Durvalumab Monotherapy Versus SoC in Terms of OS in PD-L1-High Analysis Set
Timepoint [2] 0 0
From randomization date until death due to any cause, assessed up to the data cut-off date (27JAN2020, a maximum of 5 years).
Secondary outcome [1] 0 0
OS, Full Analysis Set - Durvalumab Monotherapy vs SoC
Timepoint [1] 0 0
From randomization date until death due to any cause, assessed up to the data cut-off date (27JAN2020, a maximum of 5 years).
Secondary outcome [2] 0 0
OS, PD-L1-High Analysis Set -Durvalumab + Tremelimumab Combination Therapy Versus SoC
Timepoint [2] 0 0
From randomization date until death due to any cause, assessed up to the data cut-off date (27JAN2020, a maximum of 5 years).
Secondary outcome [3] 0 0
OS, PD-L1-Low/Negative Analysis Set -Durvalumab + Tremelimumab Combination Therapy Versus SoC and Durvalumab + Tremelimumab Combination Therapy Versus Durvalumab Monotherapy
Timepoint [3] 0 0
From randomization date until death due to any cause, assessed up to the data cut-off date (27JAN2020, a maximum of 5 years).
Secondary outcome [4] 0 0
Alive at 24 Months (OS24), Full Analysis Set
Timepoint [4] 0 0
From randomization date until death due to any cause, assessed up to 24 months or the data cut-off date (27JAN2020).
Secondary outcome [5] 0 0
Alive at 24 Months (OS24), PD-L1-High Analysis Set
Timepoint [5] 0 0
From randomization date until death due to any cause, assessed up to 24 months or the data cut-off date (27JAN2020).
Secondary outcome [6] 0 0
Alive at 24 Months (OS24), PD-L1-Low/Negative Analysis Set
Timepoint [6] 0 0
From randomization date until death due to any cause, assessed up to 24 months or the data cut-off date (27JAN2020).
Secondary outcome [7] 0 0
PFS, Full Analysis Set -Durvalumab + Tremelimumab Combination Therapy vs SoC and Durvalumab Mono Therapy vs SoC
Timepoint [7] 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).
Secondary outcome [8] 0 0
PFS, PD-L1-High Analysis Set -Durvalumab + Tremelimumab Combination Therapy vs SoC and Durvalumab Monotherapy vs SoC
Timepoint [8] 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).
Secondary outcome [9] 0 0
PFS, PD-L1-Low/Negative Analysis Set -Durvalumab + Tremelimumab Combination Therapy Versus SoC and Durvalumab + Tremelimumab Combination Therapy Versus Durvalumab Monotherapy
Timepoint [9] 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).
Secondary outcome [10] 0 0
Alive and Progression-free at 12 Months (APF12), Full Analysis Set
Timepoint [10] 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).
Secondary outcome [11] 0 0
Alive and Progression-free at 12 Months (APF12), PD-L1-High Analysis Set
Timepoint [11] 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).
Secondary outcome [12] 0 0
Alive and Progression-free at 12 Months (APF12), PD-L1-Low/Negative Analysis Set
Timepoint [12] 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).
Secondary outcome [13] 0 0
PFS2, Full Analysis Set -Durvalumab + Tremelimumab Combination Therapy vs SoC and Durvalumab Mono Therapy vs SoC
Timepoint [13] 0 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).
Secondary outcome [14] 0 0
PFS2, PD-L1-High Analysis Set -Durvalumab + Tremelimumab Combination Therapy vs SoC and Durvalumab Monotherapy vs SoC
Timepoint [14] 0 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).
Secondary outcome [15] 0 0
PFS2, PD-L1-Low/Negative Analysis Set -Durvalumab + Tremelimumab Combination Therapy Versus SoC and Durvalumab + Tremelimumab Combination Therapy Versus Durvalumab Monotherapy
Timepoint [15] 0 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).
Secondary outcome [16] 0 0
Objective Response Rate (ORR), Full Analysis Set -Durvalumab + Tremelimumab Combination Therapy vs SoC and Durvalumab Mono Therapy vs SoC
Timepoint [16] 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).
Secondary outcome [17] 0 0
Objective Response Rate (ORR), PD-L1-High Analysis Set -Durvalumab + Tremelimumab Combination Therapy vs SoC and Durvalumab Monotherapy vs SoC
Timepoint [17] 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).
Secondary outcome [18] 0 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
Timepoint [18] 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).
Secondary outcome [19] 0 0
Objective Response Rate (ORR) Based on BICR Assessment According to RECIST 1.1 - Responses Are Confirmed - Durvalumab Cisplatin Ineligible Population
Timepoint [19] 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 (01NOV2017, a maximum of 3 years).
Secondary outcome [20] 0 0
Disease Control Rate (DCR) at 6 Months, Full Analysis Set -Durvalumab + Tremelimumab Combination Therapy vs SoC and Durvalumab Mono Therapy vs SoC
Timepoint [20] 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).
Secondary outcome [21] 0 0
Disease Control Rate (DCR) at 6 Months, PD-L1-High Analysis Set -Durvalumab + Tremelimumab Combination Therapy vs SoC and Durvalumab Monotherapy vs SoC
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).
Secondary outcome [22] 0 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
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).
Secondary outcome [23] 0 0
Disease Control Rate (DCR) at 12 Months, Full Analysis Set -Durvalumab + Tremelimumab Combination Therapy vs SoC and Durvalumab Mono Therapy vs SoC
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)
Secondary outcome [24] 0 0
Disease Control Rate (DCR) at 12 Months, PD-L1-High Analysis Set -Durvalumab + Tremelimumab Combination Therapy vs SoC and Durvalumab Monotherapy vs SoC
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).
Secondary outcome [25] 0 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
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).
Secondary outcome [26] 0 0
Duration of Response (DoR), Full Analysis Set
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).
Secondary outcome [27] 0 0
Duration of Response (DoR), PD-L1-High Analysis Set
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).
Secondary outcome [28] 0 0
Duration of Response (DoR), PD-L1-Low/Negative Analysis Set
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).
Secondary outcome [29] 0 0
Serum Concentrations of Durvalumab, Pharmacokinetic Analysis Set
Timepoint [29] 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.
Secondary outcome [30] 0 0
Serum Concentrations of Tremelimumab, Pharmacokinetic Analysis Set
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.
Secondary outcome [31] 0 0
Number of Participants With Anti-Drug Antibody (ADA) Response to Durvalumab, Safety Analysis Set - ADA Evaluable Patients
Timepoint [31] 0 0
At week 0, 4, 12 and 24, and at follow-up Month 3.
Secondary outcome [32] 0 0
Number of Participants With Anti-Drug Antibody (ADA) Response to Tremelimumab, Safety Analysis Set - ADA Evaluable Patients
Timepoint [32] 0 0
At week 0, 4, 12 and at follow-up Month 3.
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
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).
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
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).
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
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).
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
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).
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
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).
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
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).

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

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



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

Recruitment
Recruitment status
Active, not recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
2/11/2015
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
30/12/2024
Actual
Sample size
Target
Accrual to date
Final
1126
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
Research Site - Box Hill
Recruitment hospital [2] 0 0
Research Site - Elizabeth Vale
Recruitment hospital [3] 0 0
Research Site - Macquarie University
Recruitment hospital [4] 0 0
Research Site - St Leonards
Recruitment hospital [5] 0 0
Research Site - Waratah
Recruitment postcode(s) [1] 0 0
3128 - Box Hill
Recruitment postcode(s) [2] 0 0
5112 - Elizabeth Vale
Recruitment postcode(s) [3] 0 0
2109 - Macquarie University
Recruitment postcode(s) [4] 0 0
2065 - St Leonards
Recruitment postcode(s) [5] 0 0
2298 - Waratah
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
California
Country [2] 0 0
United States of America
State/province [2] 0 0
Colorado
Country [3] 0 0
United States of America
State/province [3] 0 0
Connecticut
Country [4] 0 0
United States of America
State/province [4] 0 0
Florida
Country [5] 0 0
United States of America
State/province [5] 0 0
Georgia
Country [6] 0 0
United States of America
State/province [6] 0 0
Kentucky
Country [7] 0 0
United States of America
State/province [7] 0 0
Massachusetts
Country [8] 0 0
United States of America
State/province [8] 0 0
Michigan
Country [9] 0 0
United States of America
State/province [9] 0 0
Nebraska
Country [10] 0 0
United States of America
State/province [10] 0 0
New York
Country [11] 0 0
United States of America
State/province [11] 0 0
Tennessee
Country [12] 0 0
United States of America
State/province [12] 0 0
Washington
Country [13] 0 0
Austria
State/province [13] 0 0
Linz
Country [14] 0 0
Austria
State/province [14] 0 0
Wien
Country [15] 0 0
Belgium
State/province [15] 0 0
Brussels
Country [16] 0 0
Belgium
State/province [16] 0 0
Bruxelles
Country [17] 0 0
Belgium
State/province [17] 0 0
Leuven
Country [18] 0 0
Belgium
State/province [18] 0 0
Liège
Country [19] 0 0
Brazil
State/province [19] 0 0
Barretos
Country [20] 0 0
Brazil
State/province [20] 0 0
Belo Horizonte
Country [21] 0 0
Brazil
State/province [21] 0 0
Ijui
Country [22] 0 0
Brazil
State/province [22] 0 0
Itajai
Country [23] 0 0
Brazil
State/province [23] 0 0
Porto Alegre
Country [24] 0 0
Brazil
State/province [24] 0 0
Rio de Janeiro
Country [25] 0 0
Brazil
State/province [25] 0 0
Sao Paulo
Country [26] 0 0
Brazil
State/province [26] 0 0
São José do Rio Preto
Country [27] 0 0
Canada
State/province [27] 0 0
Alberta
Country [28] 0 0
Canada
State/province [28] 0 0
British Columbia
Country [29] 0 0
Canada
State/province [29] 0 0
Nova Scotia
Country [30] 0 0
Canada
State/province [30] 0 0
Ontario
Country [31] 0 0
Canada
State/province [31] 0 0
Quebec
Country [32] 0 0
China
State/province [32] 0 0
Beijing
Country [33] 0 0
China
State/province [33] 0 0
Changchun
Country [34] 0 0
China
State/province [34] 0 0
Changsha
Country [35] 0 0
China
State/province [35] 0 0
Chongqing
Country [36] 0 0
China
State/province [36] 0 0
Hangzhou
Country [37] 0 0
China
State/province [37] 0 0
Nanjing
Country [38] 0 0
China
State/province [38] 0 0
Shanghai
Country [39] 0 0
China
State/province [39] 0 0
Shenyang
Country [40] 0 0
China
State/province [40] 0 0
Tianjin
Country [41] 0 0
China
State/province [41] 0 0
Xi'an
Country [42] 0 0
China
State/province [42] 0 0
Xiamen
Country [43] 0 0
Denmark
State/province [43] 0 0
Herlev
Country [44] 0 0
Denmark
State/province [44] 0 0
København Ø
Country [45] 0 0
Denmark
State/province [45] 0 0
Odense C
Country [46] 0 0
Denmark
State/province [46] 0 0
Århus C
Country [47] 0 0
France
State/province [47] 0 0
Bordeaux
Country [48] 0 0
France
State/province [48] 0 0
Caen Cedex
Country [49] 0 0
France
State/province [49] 0 0
Lyon Cedex 08
Country [50] 0 0
France
State/province [50] 0 0
Marseille cedex 09
Country [51] 0 0
France
State/province [51] 0 0
Paris Cedex 10
Country [52] 0 0
France
State/province [52] 0 0
Poitiers Cedex
Country [53] 0 0
France
State/province [53] 0 0
Suresnes Cedex
Country [54] 0 0
France
State/province [54] 0 0
Toulouse
Country [55] 0 0
France
State/province [55] 0 0
Villejuif
Country [56] 0 0
Germany
State/province [56] 0 0
Düsseldorf
Country [57] 0 0
Germany
State/province [57] 0 0
Erlangen
Country [58] 0 0
Germany
State/province [58] 0 0
Hannover
Country [59] 0 0
Germany
State/province [59] 0 0
Heidelberg
Country [60] 0 0
Germany
State/province [60] 0 0
Jena
Country [61] 0 0
Germany
State/province [61] 0 0
München
Country [62] 0 0
Germany
State/province [62] 0 0
Münster
Country [63] 0 0
Greece
State/province [63] 0 0
Athens
Country [64] 0 0
Greece
State/province [64] 0 0
Heraklion
Country [65] 0 0
Greece
State/province [65] 0 0
Holargos, Athens
Country [66] 0 0
Greece
State/province [66] 0 0
Maroussi, Athens
Country [67] 0 0
Greece
State/province [67] 0 0
Patras
Country [68] 0 0
Greece
State/province [68] 0 0
Thessaloniki
Country [69] 0 0
Israel
State/province [69] 0 0
Haifa
Country [70] 0 0
Israel
State/province [70] 0 0
Jerusalem
Country [71] 0 0
Israel
State/province [71] 0 0
Petach-Tikva
Country [72] 0 0
Israel
State/province [72] 0 0
Ramat Gan
Country [73] 0 0
Israel
State/province [73] 0 0
Zerifin
Country [74] 0 0
Italy
State/province [74] 0 0
Arezzo
Country [75] 0 0
Italy
State/province [75] 0 0
Meldola
Country [76] 0 0
Italy
State/province [76] 0 0
Milano
Country [77] 0 0
Italy
State/province [77] 0 0
Napoli
Country [78] 0 0
Italy
State/province [78] 0 0
Orbassano
Country [79] 0 0
Italy
State/province [79] 0 0
Pavia
Country [80] 0 0
Italy
State/province [80] 0 0
Roma
Country [81] 0 0
Italy
State/province [81] 0 0
San Giovanni Rotondo
Country [82] 0 0
Japan
State/province [82] 0 0
Akita-shi
Country [83] 0 0
Japan
State/province [83] 0 0
Bunkyo-ku
Country [84] 0 0
Japan
State/province [84] 0 0
Fukuoka-shi
Country [85] 0 0
Japan
State/province [85] 0 0
Hakata-shi
Country [86] 0 0
Japan
State/province [86] 0 0
Hirosaki-shi
Country [87] 0 0
Japan
State/province [87] 0 0
Hiroshima-shi
Country [88] 0 0
Japan
State/province [88] 0 0
Izumo-shi
Country [89] 0 0
Japan
State/province [89] 0 0
Kagoshima-shi
Country [90] 0 0
Japan
State/province [90] 0 0
Kanazawa-shi
Country [91] 0 0
Japan
State/province [91] 0 0
Kita-gun
Country [92] 0 0
Japan
State/province [92] 0 0
Kobe-shi
Country [93] 0 0
Japan
State/province [93] 0 0
Koshigaya-shi
Country [94] 0 0
Japan
State/province [94] 0 0
Koto-ku
Country [95] 0 0
Japan
State/province [95] 0 0
Kumamoto-shi
Country [96] 0 0
Japan
State/province [96] 0 0
Kyoto-shi
Country [97] 0 0
Japan
State/province [97] 0 0
Matsuyama-shi
Country [98] 0 0
Japan
State/province [98] 0 0
Morioka-shi
Country [99] 0 0
Japan
State/province [99] 0 0
Nagasaki-shi
Country [100] 0 0
Japan
State/province [100] 0 0
Nagoya-shi
Country [101] 0 0
Japan
State/province [101] 0 0
Osaka-shi
Country [102] 0 0
Japan
State/province [102] 0 0
Osakasayama-shi
Country [103] 0 0
Japan
State/province [103] 0 0
Saga-shi
Country [104] 0 0
Japan
State/province [104] 0 0
Sagamihara-shi
Country [105] 0 0
Japan
State/province [105] 0 0
Sakura-shi
Country [106] 0 0
Japan
State/province [106] 0 0
Sapporo-shi
Country [107] 0 0
Japan
State/province [107] 0 0
Suita-shi
Country [108] 0 0
Japan
State/province [108] 0 0
Takatsuki-shi
Country [109] 0 0
Japan
State/province [109] 0 0
Yokohama-shi
Country [110] 0 0
Korea, Republic of
State/province [110] 0 0
Incheon
Country [111] 0 0
Korea, Republic of
State/province [111] 0 0
Seongnam-si
Country [112] 0 0
Korea, Republic of
State/province [112] 0 0
Seoul
Country [113] 0 0
Mexico
State/province [113] 0 0
Guadalajara
Country [114] 0 0
Mexico
State/province [114] 0 0
León
Country [115] 0 0
Mexico
State/province [115] 0 0
Mexico, D.F
Country [116] 0 0
Mexico
State/province [116] 0 0
Mexico
Country [117] 0 0
Mexico
State/province [117] 0 0
Monterrey
Country [118] 0 0
Mexico
State/province [118] 0 0
México
Country [119] 0 0
Netherlands
State/province [119] 0 0
Amsterdam
Country [120] 0 0
Netherlands
State/province [120] 0 0
Breda
Country [121] 0 0
Netherlands
State/province [121] 0 0
Enschede
Country [122] 0 0
Netherlands
State/province [122] 0 0
Groningen
Country [123] 0 0
Netherlands
State/province [123] 0 0
Leiden
Country [124] 0 0
Netherlands
State/province [124] 0 0
Maastricht
Country [125] 0 0
Netherlands
State/province [125] 0 0
Nijmegen
Country [126] 0 0
Poland
State/province [126] 0 0
Gdansk
Country [127] 0 0
Poland
State/province [127] 0 0
Gdynia
Country [128] 0 0
Poland
State/province [128] 0 0
Gliwice
Country [129] 0 0
Poland
State/province [129] 0 0
Olsztyn
Country [130] 0 0
Poland
State/province [130] 0 0
Otwock
Country [131] 0 0
Poland
State/province [131] 0 0
Szczecin
Country [132] 0 0
Poland
State/province [132] 0 0
Warszawa
Country [133] 0 0
Portugal
State/province [133] 0 0
Lisboa
Country [134] 0 0
Portugal
State/province [134] 0 0
Loures
Country [135] 0 0
Portugal
State/province [135] 0 0
Porto
Country [136] 0 0
Russian Federation
State/province [136] 0 0
Moscow
Country [137] 0 0
Russian Federation
State/province [137] 0 0
Murmansk
Country [138] 0 0
Russian Federation
State/province [138] 0 0
Nizhnyi Novgorod
Country [139] 0 0
Russian Federation
State/province [139] 0 0
Obninsk
Country [140] 0 0
Russian Federation
State/province [140] 0 0
Omsk
Country [141] 0 0
Russian Federation
State/province [141] 0 0
Saint Petersburg
Country [142] 0 0
Russian Federation
State/province [142] 0 0
Saint-Petersburg
Country [143] 0 0
Russian Federation
State/province [143] 0 0
St. Petersburg
Country [144] 0 0
Russian Federation
State/province [144] 0 0
St.Petersburg
Country [145] 0 0
Russian Federation
State/province [145] 0 0
Ufa
Country [146] 0 0
Russian Federation
State/province [146] 0 0
Yaroslavl
Country [147] 0 0
Spain
State/province [147] 0 0
Badajoz
Country [148] 0 0
Spain
State/province [148] 0 0
Badalona
Country [149] 0 0
Spain
State/province [149] 0 0
Barcelona
Country [150] 0 0
Spain
State/province [150] 0 0
Elche(Alicante)
Country [151] 0 0
Spain
State/province [151] 0 0
Madrid
Country [152] 0 0
Spain
State/province [152] 0 0
Pozuelo de Alarcon
Country [153] 0 0
Spain
State/province [153] 0 0
Santiago de Compostela
Country [154] 0 0
Spain
State/province [154] 0 0
Sevilla
Country [155] 0 0
Taiwan
State/province [155] 0 0
Kaohsiung
Country [156] 0 0
Taiwan
State/province [156] 0 0
Taichung
Country [157] 0 0
Taiwan
State/province [157] 0 0
Tainan
Country [158] 0 0
Taiwan
State/province [158] 0 0
Taipei
Country [159] 0 0
Taiwan
State/province [159] 0 0
Taoyuan City
Country [160] 0 0
Turkey
State/province [160] 0 0
Ankara
Country [161] 0 0
Turkey
State/province [161] 0 0
Edirne
Country [162] 0 0
Turkey
State/province [162] 0 0
Izmir
Country [163] 0 0
United Kingdom
State/province [163] 0 0
Cambridge
Country [164] 0 0
United Kingdom
State/province [164] 0 0
Cardiff.
Country [165] 0 0
United Kingdom
State/province [165] 0 0
Glasgow
Country [166] 0 0
United Kingdom
State/province [166] 0 0
Leeds
Country [167] 0 0
United Kingdom
State/province [167] 0 0
London
Country [168] 0 0
United Kingdom
State/province [168] 0 0
Manchester
Country [169] 0 0
United Kingdom
State/province [169] 0 0
Sheffield
Country [170] 0 0
United Kingdom
State/province [170] 0 0
Southampton
Country [171] 0 0
United Kingdom
State/province [171] 0 0
Wirral

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
AstraZeneca
Address
Country

Ethics approval
Ethics application status

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
Trial website
https://clinicaltrials.gov/study/NCT02516241
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.
Public notes

Contacts
Principal investigator
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT02516241