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/NCT03732677




Registration number
NCT03732677
Ethics application status
Date submitted
5/10/2018
Date registered
6/11/2018

Titles & IDs
Public title
Durvalumab+ Gemcitabine/Cisplatin (Neoadjuvant Treatment) and Durvalumab (Adjuvant Treatment) in Patients With MIBC
Scientific title
A Phase III, Randomized, Open-Label, Multi-Center, Global Study to Determine the Efficacy and Safety of Durvalumab in Combination With Gemcitabine+Cisplatin for Neoadjuvant Treatment Followed by Durvalumab Alone for Adjuvant Treatment in Patients With Muscle-Invasive Bladder Cancer.
Secondary ID [1] 0 0
2018-001811-59
Secondary ID [2] 0 0
D933RC00001
Universal Trial Number (UTN)
Trial acronym
NIAGARA
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Muscle Invasive Bladder Cancer 0 0
Condition category
Condition code
Cancer 0 0 0 0
Bladder - transitional cell cancer

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Durvalumab
Treatment: Drugs - Cisplatin
Treatment: Drugs - Gemcitabine

Experimental: Arm 1 - Chemotherapy + Durvalumab

Active comparator: Arm 2 - Chemotherapy alone


Treatment: Drugs: Durvalumab
Anti- PD-L1 Antibody

Treatment: Drugs: Cisplatin
Chemotherapy Agent

Treatment: Drugs: Gemcitabine
Chemotherapy agent
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Pathologic complete response (pCR) rates at time of cystectomy
Timepoint [1] 0 0
Up to 6 months
Primary outcome [2] 0 0
Event-free survival (EFS) per central review defined as time from randomization to event
Timepoint [2] 0 0
Up to 48 months
Secondary outcome [1] 0 0
Proportion of patients who achieve <P2 at time of cystectomy
Timepoint [1] 0 0
Up to 6 months
Secondary outcome [2] 0 0
EFS at 24 months (EFS24) defined as time from randomization to event
Timepoint [2] 0 0
Up to 24 months
Secondary outcome [3] 0 0
Proportion of patients who undergo cystectomy
Timepoint [3] 0 0
Up to 6 months
Secondary outcome [4] 0 0
Overall survival rate at 5 years
Timepoint [4] 0 0
Up to 60 months
Secondary outcome [5] 0 0
PFS2 defined as time from randomization to event following subsequent therapy
Timepoint [5] 0 0
Up to 84 months
Secondary outcome [6] 0 0
Safety and Tolerability as evaluated by adverse events occurring throughout the study
Timepoint [6] 0 0
Up to 84 months
Secondary outcome [7] 0 0
Immunogenicity of durvalumab when used in combination with gemcitabine/cisplatin as measured by presence of antidrug antibodies (ADA)
Timepoint [7] 0 0
Up to 12 months
Secondary outcome [8] 0 0
Overall Survival
Timepoint [8] 0 0
Up to 84 months
Secondary outcome [9] 0 0
Metastasis-free survival per investigator assessment or local biopsy review.
Timepoint [9] 0 0
Up to 48 months
Secondary outcome [10] 0 0
Disease-specific survival per investigator assessment or local biopsy review.
Timepoint [10] 0 0
up to 48 months
Secondary outcome [11] 0 0
Disease-free survival
Timepoint [11] 0 0
Up to 48 months

Eligibility
Key inclusion criteria
Inclusion:

* Patient resectable muscle-invasive bladder cancer with clinical stage T2-T4aN0/1M0 with transitional and mixed transitional cell histology
* Patients must be planning to undergo a radical cystectomy
* Patients who have not received prior systemic chemotherapy or immunotherapy for treatment of MIBC
* ECOG performance status of 0 or 1
* Must have a life expectancy of at least 12 weeks at randomization
Minimum age
18 Years
Maximum age
130 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Exclusion:

* Evidence of lymph node (N2-N3) or metastatic (M1) disease at time of screening.
* Prior pelvic radiotherapy treatment within 2 years of randomization to study
* Prior exposure to immune-mediated therapy (with exclusion of Bacillus-Calmette Guerin [BCG]), including but not limited to other anti-CTLA-4, anti-PD-1, anti PD-L1, or anti-PD-L2 antibodies.
* 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.
* Uncontrolled intercurrent illness
* Active infection including Tuberculosis, Hepatitis B, Hepatitis C, and Human Immunodeficiency

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
16/11/2018
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
30/06/2026
Actual
Sample size
Target
Accrual to date
Final
1063
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
Research Site - Brisbane
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 - Melbourne
Recruitment hospital [5] 0 0
Research Site - Murdoch
Recruitment hospital [6] 0 0
Research Site - South Brisbane
Recruitment postcode(s) [1] 0 0
4122 - Brisbane
Recruitment postcode(s) [2] 0 0
5112 - Elizabeth Vale
Recruitment postcode(s) [3] 0 0
2109 - Macquarie University
Recruitment postcode(s) [4] 0 0
3004 - Melbourne
Recruitment postcode(s) [5] 0 0
6150 - Murdoch
Recruitment postcode(s) [6] 0 0
4101 - South Brisbane
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Alabama
Country [2] 0 0
United States of America
State/province [2] 0 0
California
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
Illinois
Country [5] 0 0
United States of America
State/province [5] 0 0
Iowa
Country [6] 0 0
United States of America
State/province [6] 0 0
Kansas
Country [7] 0 0
United States of America
State/province [7] 0 0
Kentucky
Country [8] 0 0
United States of America
State/province [8] 0 0
Louisiana
Country [9] 0 0
United States of America
State/province [9] 0 0
Maryland
Country [10] 0 0
United States of America
State/province [10] 0 0
Michigan
Country [11] 0 0
United States of America
State/province [11] 0 0
New York
Country [12] 0 0
United States of America
State/province [12] 0 0
Pennsylvania
Country [13] 0 0
United States of America
State/province [13] 0 0
Vermont
Country [14] 0 0
United States of America
State/province [14] 0 0
Wisconsin
Country [15] 0 0
Belgium
State/province [15] 0 0
Brugge
Country [16] 0 0
Belgium
State/province [16] 0 0
Charleroi
Country [17] 0 0
Belgium
State/province [17] 0 0
Kortrijk
Country [18] 0 0
Belgium
State/province [18] 0 0
Leuven
Country [19] 0 0
Belgium
State/province [19] 0 0
Liège
Country [20] 0 0
Belgium
State/province [20] 0 0
Roeselare
Country [21] 0 0
Brazil
State/province [21] 0 0
Barretos
Country [22] 0 0
Brazil
State/province [22] 0 0
Porto Alegre
Country [23] 0 0
Brazil
State/province [23] 0 0
Rio de Janeiro
Country [24] 0 0
Brazil
State/province [24] 0 0
Santa Maria
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
Brazil
State/province [27] 0 0
São Paulo
Country [28] 0 0
Canada
State/province [28] 0 0
Alberta
Country [29] 0 0
Canada
State/province [29] 0 0
British Columbia
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
Chile
State/province [32] 0 0
Antofagasta
Country [33] 0 0
Chile
State/province [33] 0 0
Puerto Montt
Country [34] 0 0
Chile
State/province [34] 0 0
Santiago
Country [35] 0 0
Chile
State/province [35] 0 0
Temuco
Country [36] 0 0
Chile
State/province [36] 0 0
Viña del Mar
Country [37] 0 0
Czechia
State/province [37] 0 0
Brno
Country [38] 0 0
Czechia
State/province [38] 0 0
Hradec Kralove
Country [39] 0 0
Czechia
State/province [39] 0 0
Olomouc
Country [40] 0 0
Czechia
State/province [40] 0 0
Praha 2
Country [41] 0 0
Czechia
State/province [41] 0 0
Praha 8
Country [42] 0 0
Czechia
State/province [42] 0 0
Praha
Country [43] 0 0
France
State/province [43] 0 0
Angers Cedex 01
Country [44] 0 0
France
State/province [44] 0 0
Dijon
Country [45] 0 0
France
State/province [45] 0 0
Grenoble Cedex 09
Country [46] 0 0
France
State/province [46] 0 0
Montpellier
Country [47] 0 0
France
State/province [47] 0 0
Nimes
Country [48] 0 0
France
State/province [48] 0 0
Pierre Benite
Country [49] 0 0
France
State/province [49] 0 0
Poitiers Cedex
Country [50] 0 0
France
State/province [50] 0 0
Rouen
Country [51] 0 0
Germany
State/province [51] 0 0
Bergisch Gladbach
Country [52] 0 0
Germany
State/province [52] 0 0
Bonn
Country [53] 0 0
Germany
State/province [53] 0 0
Erlangen
Country [54] 0 0
Germany
State/province [54] 0 0
Göttingen
Country [55] 0 0
Germany
State/province [55] 0 0
Herne
Country [56] 0 0
Germany
State/province [56] 0 0
Jena
Country [57] 0 0
Germany
State/province [57] 0 0
Köln
Country [58] 0 0
Germany
State/province [58] 0 0
Magdeburg
Country [59] 0 0
Germany
State/province [59] 0 0
Mannheim
Country [60] 0 0
Germany
State/province [60] 0 0
Münster
Country [61] 0 0
Germany
State/province [61] 0 0
Nürnberg
Country [62] 0 0
Germany
State/province [62] 0 0
Oldenburg
Country [63] 0 0
Germany
State/province [63] 0 0
Regensburg
Country [64] 0 0
Germany
State/province [64] 0 0
Ulm
Country [65] 0 0
Germany
State/province [65] 0 0
Würzburg
Country [66] 0 0
Israel
State/province [66] 0 0
Haifa
Country [67] 0 0
Israel
State/province [67] 0 0
Jerusalem
Country [68] 0 0
Israel
State/province [68] 0 0
Kfar Saba
Country [69] 0 0
Israel
State/province [69] 0 0
Petach-Tikva
Country [70] 0 0
Israel
State/province [70] 0 0
Ramat Gan
Country [71] 0 0
Italy
State/province [71] 0 0
Bari
Country [72] 0 0
Italy
State/province [72] 0 0
Bologna
Country [73] 0 0
Italy
State/province [73] 0 0
Firenze
Country [74] 0 0
Italy
State/province [74] 0 0
Milano
Country [75] 0 0
Italy
State/province [75] 0 0
Napoli
Country [76] 0 0
Italy
State/province [76] 0 0
Orbassano
Country [77] 0 0
Italy
State/province [77] 0 0
Pozzuoli
Country [78] 0 0
Italy
State/province [78] 0 0
Verona
Country [79] 0 0
Japan
State/province [79] 0 0
Bunkyo-ku
Country [80] 0 0
Japan
State/province [80] 0 0
Fukuoka-shi
Country [81] 0 0
Japan
State/province [81] 0 0
Fukuoka
Country [82] 0 0
Japan
State/province [82] 0 0
Hirosaki-shi
Country [83] 0 0
Japan
State/province [83] 0 0
Hiroshima-shi
Country [84] 0 0
Japan
State/province [84] 0 0
Kanazawa-shi
Country [85] 0 0
Japan
State/province [85] 0 0
Koto-ku
Country [86] 0 0
Japan
State/province [86] 0 0
Kumamoto-shi
Country [87] 0 0
Japan
State/province [87] 0 0
Miyazaki-city
Country [88] 0 0
Japan
State/province [88] 0 0
Nagasaki-shi
Country [89] 0 0
Japan
State/province [89] 0 0
Nagoya-shi
Country [90] 0 0
Japan
State/province [90] 0 0
Niigata-shi
Country [91] 0 0
Japan
State/province [91] 0 0
Osaka-shi
Country [92] 0 0
Japan
State/province [92] 0 0
Osakasayama-shi
Country [93] 0 0
Japan
State/province [93] 0 0
Sendai-shi
Country [94] 0 0
Japan
State/province [94] 0 0
Toyama-shi
Country [95] 0 0
Japan
State/province [95] 0 0
Tsukuba-shi
Country [96] 0 0
Japan
State/province [96] 0 0
Yokohama-shi
Country [97] 0 0
Korea, Republic of
State/province [97] 0 0
Daegu
Country [98] 0 0
Korea, Republic of
State/province [98] 0 0
Goyang-si
Country [99] 0 0
Korea, Republic of
State/province [99] 0 0
Gyeonggi-do
Country [100] 0 0
Korea, Republic of
State/province [100] 0 0
Incheon
Country [101] 0 0
Korea, Republic of
State/province [101] 0 0
Seoul
Country [102] 0 0
Netherlands
State/province [102] 0 0
Amsterdam
Country [103] 0 0
Netherlands
State/province [103] 0 0
Breda
Country [104] 0 0
Netherlands
State/province [104] 0 0
Rotterdam
Country [105] 0 0
Philippines
State/province [105] 0 0
Baguio City
Country [106] 0 0
Philippines
State/province [106] 0 0
Cebu
Country [107] 0 0
Philippines
State/province [107] 0 0
Davao City
Country [108] 0 0
Philippines
State/province [108] 0 0
Makati
Country [109] 0 0
Philippines
State/province [109] 0 0
Manila
Country [110] 0 0
Philippines
State/province [110] 0 0
Quezon City
Country [111] 0 0
Poland
State/province [111] 0 0
Bialystok
Country [112] 0 0
Poland
State/province [112] 0 0
Gdansk
Country [113] 0 0
Poland
State/province [113] 0 0
Grudziadz
Country [114] 0 0
Poland
State/province [114] 0 0
Koszalin
Country [115] 0 0
Poland
State/province [115] 0 0
Kraków
Country [116] 0 0
Poland
State/province [116] 0 0
Olsztyn
Country [117] 0 0
Poland
State/province [117] 0 0
Ostroleka
Country [118] 0 0
Poland
State/province [118] 0 0
Poznan
Country [119] 0 0
Poland
State/province [119] 0 0
Warszawa
Country [120] 0 0
Poland
State/province [120] 0 0
Wroclaw
Country [121] 0 0
Russian Federation
State/province [121] 0 0
Krasnoyarsk
Country [122] 0 0
Russian Federation
State/province [122] 0 0
Moscow
Country [123] 0 0
Russian Federation
State/province [123] 0 0
Nizhniy Novgorod
Country [124] 0 0
Russian Federation
State/province [124] 0 0
Novosibirsk
Country [125] 0 0
Russian Federation
State/province [125] 0 0
Samara
Country [126] 0 0
Russian Federation
State/province [126] 0 0
St Petersburg
Country [127] 0 0
Russian Federation
State/province [127] 0 0
St. Petersburg
Country [128] 0 0
Russian Federation
State/province [128] 0 0
Ufa
Country [129] 0 0
Russian Federation
State/province [129] 0 0
Vologda
Country [130] 0 0
Spain
State/province [130] 0 0
Badalona
Country [131] 0 0
Spain
State/province [131] 0 0
Barcelona
Country [132] 0 0
Spain
State/province [132] 0 0
Córdoba
Country [133] 0 0
Spain
State/province [133] 0 0
Las Palmas de Gran Canaria
Country [134] 0 0
Spain
State/province [134] 0 0
Madrid
Country [135] 0 0
Spain
State/province [135] 0 0
Santander
Country [136] 0 0
Spain
State/province [136] 0 0
Sevilla
Country [137] 0 0
Taiwan
State/province [137] 0 0
Kaohsiung
Country [138] 0 0
Taiwan
State/province [138] 0 0
Taichung
Country [139] 0 0
Taiwan
State/province [139] 0 0
Tainan
Country [140] 0 0
Taiwan
State/province [140] 0 0
Taipei City
Country [141] 0 0
Taiwan
State/province [141] 0 0
Taipei
Country [142] 0 0
Taiwan
State/province [142] 0 0
Taoyuan City
Country [143] 0 0
Turkey
State/province [143] 0 0
Ankara
Country [144] 0 0
Turkey
State/province [144] 0 0
Edirne
Country [145] 0 0
Turkey
State/province [145] 0 0
Istanbul
Country [146] 0 0
Turkey
State/province [146] 0 0
Izmir
Country [147] 0 0
Turkey
State/province [147] 0 0
Karsiyaka
Country [148] 0 0
United Kingdom
State/province [148] 0 0
Edinburgh
Country [149] 0 0
United Kingdom
State/province [149] 0 0
London
Country [150] 0 0
United Kingdom
State/province [150] 0 0
Nottingham
Country [151] 0 0
United Kingdom
State/province [151] 0 0
Sheffield
Country [152] 0 0
United Kingdom
State/province [152] 0 0
Wirral
Country [153] 0 0
Vietnam
State/province [153] 0 0
Hanoi
Country [154] 0 0
Vietnam
State/province [154] 0 0
Ho Chi Minh
Country [155] 0 0
Vietnam
State/province [155] 0 0
Hochiminh

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

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
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

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
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)
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.
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.
Available for what types of analyses?
How or where can data be obtained?
IPD available at link: https://astrazenecagroup-dt.pharmacm.com/DT/Home


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/NCT03732677