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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
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United States of America
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Alabama
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California
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Vermont
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Wisconsin
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Brugge
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Kaohsiung
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Taichung
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Tainan
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Taipei City
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Turkey
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Ankara
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Edirne
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Istanbul
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Izmir
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Karsiyaka
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United Kingdom
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Edinburgh
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London
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Nottingham
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Sheffield
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Wirral
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Hanoi
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Ho Chi Minh
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Vietnam
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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