Please note that the copy function is not enabled for this field.
If you wish to
modify
existing outcomes, please copy and paste the current outcome text into the Update field.
LOGIN
CREATE ACCOUNT
MY TRIALS
LOGIN
CREATE ACCOUNT
MY TRIALS
REGISTER TRIAL
FAQs
HINTS AND TIPS
DEFINITIONS
Register a trial
The ANZCTR website will be unavailable from 1pm until 3pm (AEDT) on Wednesday the 30th of October for website maintenance. Please be sure to log out of the system in order to avoid any loss of data.
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/NCT03682068
Registration number
NCT03682068
Ethics application status
Date submitted
6/09/2018
Date registered
24/09/2018
Titles & IDs
Public title
Study of Durvalumab Given With Chemotherapy, Durvalumab in Combination With Tremelimumab Given With Chemotherapy, or Chemotherapy in Patients With Unresectable Urothelial Cancer
Query!
Scientific title
A Phase III, Randomized, Open-Label, Controlled, Multi-Center, Global Study of First-Line Durvalumab in Combination With Standard of Care Chemotherapy and Durvalumab in Combination With Tremelimumab and Standard of Care Chemotherapy Versus Standard of Care Chemotherapy Alone in Patients With Unresectable Locally Advanced or Metastatic Urothelial Cancer.
Query!
Secondary ID [1]
0
0
2018-001883-48
Query!
Secondary ID [2]
0
0
D933SC00001
Query!
Universal Trial Number (UTN)
Query!
Trial acronym
NILE
Query!
Linked study record
Query!
Health condition
Health condition(s) or problem(s) studied:
Unresectable Locally Advanced Urothelial Cancer
0
0
Query!
Metastatic Urothelial Cancer
0
0
Query!
Condition category
Condition code
Intervention/exposure
Study type
Interventional
Query!
Description of intervention(s) / exposure
Treatment: Drugs - Durvalumab
Treatment: Drugs - Tremelimumab
Treatment: Drugs - Cisplatin + Gemcitabine
Treatment: Drugs - Carboplatin + Gemcitabine
Experimental: Durvalumab in Combination with SoC Chemotherapy - Durvalumab every 3 weeks in concurrence with chemotherapy, followed by durvalumab monotherapy every 4 weeks.
All patients will receive one of the following standard of care chemotherapy regimens every 3 weeks for 6 cycles:
* cisplatin+ gemcitabine
* If the patient is cisplatin-ineligible, carboplatin + gemcitabine
Experimental: Durvalumab in Combination with Tremelimumab+SoC Chemotherapy - Durvalumab and Tremelimumab every 3 weeks in concurrence with chemotherapy, followed by durvalumab monotherapy every 4 weeks
Tremelimumab will be provided for 4 cycles.
All patients will receive one of the following standard of care chemotherapy regimens every 3 weeks for 6 cycles:
* cisplatin+ gemcitabine
* If the patient is cisplatin-ineligible, carboplatin + gemcitabine
Active comparator: SoC Chemotherapy - Patients will receive one of the following standard of care chemotherapy regimens every 3 weeks for 6 cycles:
* cisplatin+ gemcitabine
* If the patient is cisplatin-ineligible, carboplatin + gemcitabine
Treatment: Drugs: Durvalumab
Durvalumab IV (intravenous infusion)
Treatment: Drugs: Tremelimumab
Tremelimumab IV (intravenous infusion)
Treatment: Drugs: Cisplatin + Gemcitabine
Cisplatin IV (intravenous)+ Gemcitabine IV(intravenous), as standard of care.
Treatment: Drugs: Carboplatin + Gemcitabine
Carboplatin IV (intravenous)+ Gemcitabine IV(intravenous), as standard of care.
Query!
Intervention code [1]
0
0
Treatment: Drugs
Query!
Comparator / control treatment
Query!
Control group
Query!
Outcomes
Primary outcome [1]
0
0
Overall Survival (OS)
Query!
Assessment method [1]
0
0
OS is defined as the time from the date of randomization until death due to any cause
Query!
Timepoint [1]
0
0
approximately 5 years
Query!
Secondary outcome [1]
0
0
Overall Survival (OS)
Query!
Assessment method [1]
0
0
Additional analysis beyond the primary endpoint
Query!
Timepoint [1]
0
0
approximately 5 years
Query!
Secondary outcome [2]
0
0
Overall Survival at 24 months (OS24)
Query!
Assessment method [2]
0
0
The OS24 will be defined as the Kaplan-Meier estimate of OS at 24 months
Query!
Timepoint [2]
0
0
24 months
Query!
Secondary outcome [3]
0
0
Progression Free Survival (PFS)
Query!
Assessment method [3]
0
0
PFS (per RECIST 1.1) will be defined as the time from the date of randomization until the date of first objective disease progression or death
Query!
Timepoint [3]
0
0
approximately 5 years
Query!
Secondary outcome [4]
0
0
Alive and Progression Free Survival at 12 months (APF12)
Query!
Assessment method [4]
0
0
The APF12 will be defined as the Kaplan-Meier estimate of PFS (per RECIST 1.1) at 12 months
Query!
Timepoint [4]
0
0
12 months
Query!
Secondary outcome [5]
0
0
Objective Response Rate (ORR)
Query!
Assessment method [5]
0
0
ORR (per RECIST 1.1) is defined as the number (%) of patients with at least 1 visit response of complete response or partial response and will be based on a subset of all randomized patients
Query!
Timepoint [5]
0
0
approximately 5 years
Query!
Secondary outcome [6]
0
0
Duration of Response (DoR)
Query!
Assessment method [6]
0
0
DoR (per RECIST 1.1) will be 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
Query!
Timepoint [6]
0
0
approximately 5 years
Query!
Secondary outcome [7]
0
0
Disease Control Rate (DCR)
Query!
Assessment method [7]
0
0
DCR is defined as the proportion of subjects with the best overall response of complete response, partial response or stable disease per RECIST 1.1
Query!
Timepoint [7]
0
0
approximately 5 years
Query!
Secondary outcome [8]
0
0
Time from randomization to second (PFS2)
Query!
Assessment method [8]
0
0
PFS2 will be defined as the time from the date of randomization to the earliest of the progression events subsequent to that used for the PFS endpoint or death
Query!
Timepoint [8]
0
0
approximately 5 years
Query!
Secondary outcome [9]
0
0
To assess disease-related symptoms, physical functioning, and other Health-related quality of life
Query!
Assessment method [9]
0
0
Collection of patient reported outcome questionnaires
Query!
Timepoint [9]
0
0
approximately 5 years
Query!
Eligibility
Key inclusion criteria
Key
* Patients with histologically or cytologically documented, unresectable, locally advanced or metastatic transitional cell carcinoma (transitional cell and mixed transitional/non-transitional cell histologies) of the urothelium (including renal pelvis, ureters, urinary bladder, and urethra)
* Patients who have not been previously treated with first-line chemotherapy. Patients who have received prior definitive chemoradiation, adjuvant or neoadjuvant treatment for locally advanced disease are eligible provided that progression to locally advanced or metastatic disease has occurred >12 months from the last therapy [for chemoradiation and adjuvant treatment] or >12 months from the last surgery [for neoadjuvant treatment].
* At least 1 lesion, not previously irradiated, that qualifies as a RECIST 1.1 target lesion at baseline.
* World Health Organization (WHO)/Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0 or 1 at enrolment
* Adequate organ and marrow function as defined in the protocol
* Life expectancy =12 weeks in the opinion of the investigator
* Evidence of post-menopausal status, or negative urinary or serum pregnancy test for female pre-menopausal patients.
Key
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 (with exclusion of Bacillus Calmette Guerin), including but not limited to, other anti-CTLA-4, anti-PD-1, anti-PD L1, or anti-PD-L2 antibodies, except therapeutic anticancer vaccines, which are permitted. Prior local intervesical chemotherapy or immunotherapy is allowed if completed at least 28 days prior to the initiation of study treatment.
* No severe concomitant condition that requires immunosuppression medication
* Untreated central nervous system (CNS) metastases and/or carcinomatous meningitis
* Patients who may be eligible for or are being considered for radical resection during the course of the study.
* Any medical contraindications to platinum (cisplatin or carboplatin) based doublet chemotherapy and/or known allergy or hypersensitivity to any of the study drugs or any of the study drug excipients
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
27/09/2018
Query!
Date of last participant enrolment
Anticipated
Query!
Actual
Query!
Date of last data collection
Anticipated
30/06/2025
Query!
Actual
Query!
Sample size
Target
Query!
Accrual to date
Query!
Final
1246
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 - Kogarah
Query!
Recruitment hospital [4]
0
0
Research Site - Macquarie University
Query!
Recruitment hospital [5]
0
0
Research Site - Murdoch
Query!
Recruitment hospital [6]
0
0
Research Site - Orange
Query!
Recruitment hospital [7]
0
0
Research Site - South Brisbane
Query!
Recruitment hospital [8]
0
0
Research Site - St Albans
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
2217 - Kogarah
Query!
Recruitment postcode(s) [4]
0
0
2109 - Macquarie University
Query!
Recruitment postcode(s) [5]
0
0
6150 - Murdoch
Query!
Recruitment postcode(s) [6]
0
0
2800 - Orange
Query!
Recruitment postcode(s) [7]
0
0
4101 - South Brisbane
Query!
Recruitment postcode(s) [8]
0
0
3021 - St Albans
Query!
Recruitment outside Australia
Country [1]
0
0
United States of America
Query!
State/province [1]
0
0
Alabama
Query!
Country [2]
0
0
United States of America
Query!
State/province [2]
0
0
California
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
District of Columbia
Query!
Country [5]
0
0
United States of America
Query!
State/province [5]
0
0
Florida
Query!
Country [6]
0
0
United States of America
Query!
State/province [6]
0
0
Illinois
Query!
Country [7]
0
0
United States of America
Query!
State/province [7]
0
0
Indiana
Query!
Country [8]
0
0
United States of America
Query!
State/province [8]
0
0
Kansas
Query!
Country [9]
0
0
United States of America
Query!
State/province [9]
0
0
Kentucky
Query!
Country [10]
0
0
United States of America
Query!
State/province [10]
0
0
Louisiana
Query!
Country [11]
0
0
United States of America
Query!
State/province [11]
0
0
Michigan
Query!
Country [12]
0
0
United States of America
Query!
State/province [12]
0
0
Montana
Query!
Country [13]
0
0
United States of America
Query!
State/province [13]
0
0
New York
Query!
Country [14]
0
0
United States of America
Query!
State/province [14]
0
0
Tennessee
Query!
Country [15]
0
0
United States of America
Query!
State/province [15]
0
0
Texas
Query!
Country [16]
0
0
Argentina
Query!
State/province [16]
0
0
Buenos Aires
Query!
Country [17]
0
0
Argentina
Query!
State/province [17]
0
0
Ciudad de Buenos Aires
Query!
Country [18]
0
0
Argentina
Query!
State/province [18]
0
0
Rosario
Query!
Country [19]
0
0
Brazil
Query!
State/province [19]
0
0
Curitiba
Query!
Country [20]
0
0
Brazil
Query!
State/province [20]
0
0
Fortaleza
Query!
Country [21]
0
0
Brazil
Query!
State/province [21]
0
0
Porto Alegre
Query!
Country [22]
0
0
Brazil
Query!
State/province [22]
0
0
Ribeirão Preto
Query!
Country [23]
0
0
Brazil
Query!
State/province [23]
0
0
Rio de Janeiro
Query!
Country [24]
0
0
Brazil
Query!
State/province [24]
0
0
Salvador
Query!
Country [25]
0
0
Brazil
Query!
State/province [25]
0
0
Santa Maria
Query!
Country [26]
0
0
Brazil
Query!
State/province [26]
0
0
Sao Paulo
Query!
Country [27]
0
0
Brazil
Query!
State/province [27]
0
0
São José do Rio Preto
Query!
Country [28]
0
0
Brazil
Query!
State/province [28]
0
0
São Paulo
Query!
Country [29]
0
0
Bulgaria
Query!
State/province [29]
0
0
Pleven
Query!
Country [30]
0
0
Bulgaria
Query!
State/province [30]
0
0
Plovdiv
Query!
Country [31]
0
0
Bulgaria
Query!
State/province [31]
0
0
Sofia
Query!
Country [32]
0
0
Bulgaria
Query!
State/province [32]
0
0
Varna
Query!
Country [33]
0
0
Canada
Query!
State/province [33]
0
0
Alberta
Query!
Country [34]
0
0
Canada
Query!
State/province [34]
0
0
British Columbia
Query!
Country [35]
0
0
Canada
Query!
State/province [35]
0
0
Ontario
Query!
Country [36]
0
0
Canada
Query!
State/province [36]
0
0
Quebec
Query!
Country [37]
0
0
China
Query!
State/province [37]
0
0
Beijing
Query!
Country [38]
0
0
China
Query!
State/province [38]
0
0
Changchun
Query!
Country [39]
0
0
China
Query!
State/province [39]
0
0
Changsha
Query!
Country [40]
0
0
China
Query!
State/province [40]
0
0
Chongqing
Query!
Country [41]
0
0
China
Query!
State/province [41]
0
0
Dalian
Query!
Country [42]
0
0
China
Query!
State/province [42]
0
0
Guangzhou
Query!
Country [43]
0
0
China
Query!
State/province [43]
0
0
Hangzhou
Query!
Country [44]
0
0
China
Query!
State/province [44]
0
0
Jinan
Query!
Country [45]
0
0
China
Query!
State/province [45]
0
0
Nanchang
Query!
Country [46]
0
0
China
Query!
State/province [46]
0
0
Nanjing
Query!
Country [47]
0
0
China
Query!
State/province [47]
0
0
Shanghai
Query!
Country [48]
0
0
China
Query!
State/province [48]
0
0
Shenyang
Query!
Country [49]
0
0
China
Query!
State/province [49]
0
0
Suzhou
Query!
Country [50]
0
0
China
Query!
State/province [50]
0
0
Tianjin
Query!
Country [51]
0
0
China
Query!
State/province [51]
0
0
Urumqi
Query!
Country [52]
0
0
China
Query!
State/province [52]
0
0
Wuhan
Query!
Country [53]
0
0
China
Query!
State/province [53]
0
0
Xi'an
Query!
Country [54]
0
0
Czechia
Query!
State/province [54]
0
0
Brno
Query!
Country [55]
0
0
Czechia
Query!
State/province [55]
0
0
Hradec Kralove
Query!
Country [56]
0
0
Czechia
Query!
State/province [56]
0
0
Olomouc
Query!
Country [57]
0
0
Czechia
Query!
State/province [57]
0
0
Ostrava
Query!
Country [58]
0
0
Czechia
Query!
State/province [58]
0
0
Praha 2
Query!
Country [59]
0
0
Czechia
Query!
State/province [59]
0
0
Praha 8
Query!
Country [60]
0
0
Czechia
Query!
State/province [60]
0
0
Praha
Query!
Country [61]
0
0
Hungary
Query!
State/province [61]
0
0
Budapest
Query!
Country [62]
0
0
Hungary
Query!
State/province [62]
0
0
Debrecen
Query!
Country [63]
0
0
Hungary
Query!
State/province [63]
0
0
Gyor
Query!
Country [64]
0
0
Hungary
Query!
State/province [64]
0
0
Kecskemét
Query!
Country [65]
0
0
Hungary
Query!
State/province [65]
0
0
Szolnok
Query!
Country [66]
0
0
India
Query!
State/province [66]
0
0
Gurgaon
Query!
Country [67]
0
0
India
Query!
State/province [67]
0
0
Hubli
Query!
Country [68]
0
0
India
Query!
State/province [68]
0
0
Kolkata
Query!
Country [69]
0
0
India
Query!
State/province [69]
0
0
Mysuru
Query!
Country [70]
0
0
India
Query!
State/province [70]
0
0
Nagpur
Query!
Country [71]
0
0
India
Query!
State/province [71]
0
0
Nasik
Query!
Country [72]
0
0
India
Query!
State/province [72]
0
0
New Delhi
Query!
Country [73]
0
0
India
Query!
State/province [73]
0
0
Pune
Query!
Country [74]
0
0
Israel
Query!
State/province [74]
0
0
Haifa
Query!
Country [75]
0
0
Israel
Query!
State/province [75]
0
0
Jerusalem
Query!
Country [76]
0
0
Israel
Query!
State/province [76]
0
0
Kfar Saba
Query!
Country [77]
0
0
Israel
Query!
State/province [77]
0
0
Petach-Tikva
Query!
Country [78]
0
0
Israel
Query!
State/province [78]
0
0
Ramat Gan
Query!
Country [79]
0
0
Italy
Query!
State/province [79]
0
0
Arezzo
Query!
Country [80]
0
0
Italy
Query!
State/province [80]
0
0
Milano
Query!
Country [81]
0
0
Italy
Query!
State/province [81]
0
0
Napoli
Query!
Country [82]
0
0
Italy
Query!
State/province [82]
0
0
Orbassano
Query!
Country [83]
0
0
Italy
Query!
State/province [83]
0
0
Parma
Query!
Country [84]
0
0
Italy
Query!
State/province [84]
0
0
Pavia
Query!
Country [85]
0
0
Italy
Query!
State/province [85]
0
0
Roma
Query!
Country [86]
0
0
Italy
Query!
State/province [86]
0
0
Terni
Query!
Country [87]
0
0
Italy
Query!
State/province [87]
0
0
Verona
Query!
Country [88]
0
0
Japan
Query!
State/province [88]
0
0
Bunkyo-ku
Query!
Country [89]
0
0
Japan
Query!
State/province [89]
0
0
Chuo-ku
Query!
Country [90]
0
0
Japan
Query!
State/province [90]
0
0
Fukuoka-shi
Query!
Country [91]
0
0
Japan
Query!
State/province [91]
0
0
Hirosaki-shi
Query!
Country [92]
0
0
Japan
Query!
State/province [92]
0
0
Kanazawa-shi
Query!
Country [93]
0
0
Japan
Query!
State/province [93]
0
0
Kita-gun
Query!
Country [94]
0
0
Japan
Query!
State/province [94]
0
0
Koshigaya-shi
Query!
Country [95]
0
0
Japan
Query!
State/province [95]
0
0
Koto-ku
Query!
Country [96]
0
0
Japan
Query!
State/province [96]
0
0
Kumamoto-shi
Query!
Country [97]
0
0
Japan
Query!
State/province [97]
0
0
Kyoto-shi
Query!
Country [98]
0
0
Japan
Query!
State/province [98]
0
0
Miyazaki-city
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
Niigata-shi
Query!
Country [102]
0
0
Japan
Query!
State/province [102]
0
0
Osaka-shi
Query!
Country [103]
0
0
Japan
Query!
State/province [103]
0
0
Osakasayama-shi
Query!
Country [104]
0
0
Japan
Query!
State/province [104]
0
0
Shinjuku-ku
Query!
Country [105]
0
0
Japan
Query!
State/province [105]
0
0
Suita-shi
Query!
Country [106]
0
0
Japan
Query!
State/province [106]
0
0
Toyama-shi
Query!
Country [107]
0
0
Japan
Query!
State/province [107]
0
0
Yokohama-shi
Query!
Country [108]
0
0
Korea, Republic of
Query!
State/province [108]
0
0
Goyang-si
Query!
Country [109]
0
0
Korea, Republic of
Query!
State/province [109]
0
0
Incheon
Query!
Country [110]
0
0
Korea, Republic of
Query!
State/province [110]
0
0
Seoul
Query!
Country [111]
0
0
Korea, Republic of
Query!
State/province [111]
0
0
Suwon
Query!
Country [112]
0
0
Philippines
Query!
State/province [112]
0
0
Bacolod
Query!
Country [113]
0
0
Philippines
Query!
State/province [113]
0
0
Baguio City
Query!
Country [114]
0
0
Philippines
Query!
State/province [114]
0
0
Cebu
Query!
Country [115]
0
0
Philippines
Query!
State/province [115]
0
0
Davao City
Query!
Country [116]
0
0
Philippines
Query!
State/province [116]
0
0
Makati
Query!
Country [117]
0
0
Philippines
Query!
State/province [117]
0
0
Manila
Query!
Country [118]
0
0
Philippines
Query!
State/province [118]
0
0
Quezon City
Query!
Country [119]
0
0
Poland
Query!
State/province [119]
0
0
Bialystok
Query!
Country [120]
0
0
Poland
Query!
State/province [120]
0
0
Gdansk
Query!
Country [121]
0
0
Poland
Query!
State/province [121]
0
0
Grudziadz
Query!
Country [122]
0
0
Poland
Query!
State/province [122]
0
0
Koszalin
Query!
Country [123]
0
0
Poland
Query!
State/province [123]
0
0
Kraków
Query!
Country [124]
0
0
Poland
Query!
State/province [124]
0
0
Olsztyn
Query!
Country [125]
0
0
Poland
Query!
State/province [125]
0
0
Poznan
Query!
Country [126]
0
0
Poland
Query!
State/province [126]
0
0
Radom
Query!
Country [127]
0
0
Poland
Query!
State/province [127]
0
0
Warszawa
Query!
Country [128]
0
0
Russian Federation
Query!
State/province [128]
0
0
Ivanovo
Query!
Country [129]
0
0
Russian Federation
Query!
State/province [129]
0
0
Krasnoyarsk
Query!
Country [130]
0
0
Russian Federation
Query!
State/province [130]
0
0
Moscow
Query!
Country [131]
0
0
Russian Federation
Query!
State/province [131]
0
0
Nizhniy Novgorod
Query!
Country [132]
0
0
Russian Federation
Query!
State/province [132]
0
0
Omsk
Query!
Country [133]
0
0
Russian Federation
Query!
State/province [133]
0
0
Rostov-on-Don
Query!
Country [134]
0
0
Russian Federation
Query!
State/province [134]
0
0
Saint-Petersburg
Query!
Country [135]
0
0
Russian Federation
Query!
State/province [135]
0
0
St. Petersburg
Query!
Country [136]
0
0
Russian Federation
Query!
State/province [136]
0
0
Tyumen
Query!
Country [137]
0
0
Russian Federation
Query!
State/province [137]
0
0
Vologda
Query!
Country [138]
0
0
Spain
Query!
State/province [138]
0
0
Barcelona
Query!
Country [139]
0
0
Spain
Query!
State/province [139]
0
0
Lugo
Query!
Country [140]
0
0
Spain
Query!
State/province [140]
0
0
Madrid
Query!
Country [141]
0
0
Spain
Query!
State/province [141]
0
0
Malaga
Query!
Country [142]
0
0
Spain
Query!
State/province [142]
0
0
Santander
Query!
Country [143]
0
0
Spain
Query!
State/province [143]
0
0
Sevilla
Query!
Country [144]
0
0
Taiwan
Query!
State/province [144]
0
0
Taichung
Query!
Country [145]
0
0
Taiwan
Query!
State/province [145]
0
0
Tainan
Query!
Country [146]
0
0
Taiwan
Query!
State/province [146]
0
0
Taipei City
Query!
Country [147]
0
0
Taiwan
Query!
State/province [147]
0
0
Taipei
Query!
Country [148]
0
0
Taiwan
Query!
State/province [148]
0
0
Taoyuan
Query!
Country [149]
0
0
Thailand
Query!
State/province [149]
0
0
Bangkok
Query!
Country [150]
0
0
Thailand
Query!
State/province [150]
0
0
Khon Kaen
Query!
Country [151]
0
0
Thailand
Query!
State/province [151]
0
0
Mueang
Query!
Country [152]
0
0
Thailand
Query!
State/province [152]
0
0
Songkla
Query!
Country [153]
0
0
Turkey
Query!
State/province [153]
0
0
Adana
Query!
Country [154]
0
0
Turkey
Query!
State/province [154]
0
0
Adapazari
Query!
Country [155]
0
0
Turkey
Query!
State/province [155]
0
0
Ankara
Query!
Country [156]
0
0
Turkey
Query!
State/province [156]
0
0
Edirne
Query!
Country [157]
0
0
Turkey
Query!
State/province [157]
0
0
Istanbul
Query!
Country [158]
0
0
Turkey
Query!
State/province [158]
0
0
Izmir
Query!
Country [159]
0
0
Vietnam
Query!
State/province [159]
0
0
Ha Noi
Query!
Country [160]
0
0
Vietnam
Query!
State/province [160]
0
0
Hanoi
Query!
Country [161]
0
0
Vietnam
Query!
State/province [161]
0
0
Ho Chi Minh
Query!
Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Query!
Name
AstraZeneca
Query!
Address
Query!
Country
Query!
Ethics approval
Ethics application status
Query!
Summary
Brief summary
This is a randomized, open-label, controlled, multi-center, global Phase III study to determine the efficacy and safety of combining durvalumab ± tremelimumab with standard of care (SoC) chemotherapy (cisplatin + gemcitabine or carboplatin + gemcitabine doublet) followed by durvalumab monotherapy versus SoC alone as first-line chemotherapy in patients with histologically or cytologically documented, unresectable, locally advanced or metastatic transitional cell carcinoma of the urothelium (including renal pelvis, ureters, urinary bladder, and urethra).
Query!
Trial website
https://clinicaltrials.gov/study/NCT03682068
Query!
Trial related presentations / publications
Query!
Public notes
Query!
Contacts
Principal investigator
Name
0
0
Query!
Address
0
0
Query!
Country
0
0
Query!
Phone
0
0
Query!
Fax
0
0
Query!
Email
0
0
Query!
Contact person for public queries
Name
0
0
Query!
Address
0
0
Query!
Country
0
0
Query!
Phone
0
0
Query!
Fax
0
0
Query!
Email
0
0
Query!
Contact person for scientific queries
Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
Query!
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)
Query!
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.
Query!
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.
Query!
Available for what types of analyses?
Query!
How or where can data be obtained?
IPD available at link: https://astrazenecagroup-dt.pharmacm.com/DT/Home
Query!
What supporting documents are/will be available?
No Supporting Document Provided
Results publications and other study-related documents
No documents have been uploaded by study researchers.
Results not provided in
https://clinicaltrials.gov/study/NCT03682068