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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT06960577




Registration number
NCT06960577
Ethics application status
Date submitted
29/04/2025
Date registered
7/05/2025

Titles & IDs
Public title
Perioperative Durvalumab With Neoadjuvant ddMVAC or Gemcitabine/Cisplatin in Patients With Muscle-invasive Bladder Cancer (NIAGARA-2)
Scientific title
A Phase IIIb, Open-label, Single-arm, Global Study of Perioperative Durvalumab With Neoadjuvant ddMVAC or Gem/Cis in Patients With Muscle-invasive Bladder Cancer (NIAGARA-2)
Secondary ID [1] 0 0
D933RC00002
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Urinary Bladder Neoplasms 0 0
Immune Checkpoint Inhibitors 0 0
Methotrexate 0 0
Vinblastine 0 0
Doxorubicin 0 0
Cisplatin 0 0
Gemcitabine 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 - Methotrexate
Treatment: Drugs - Vinblastine
Treatment: Drugs - Doxorubicin
Treatment: Drugs - Cisplatin
Treatment: Drugs - Durvalumab
Treatment: Drugs - Gemcitabine
Treatment: Drugs - Cisplatin

Experimental: ddMVAC cohort - Durvalumab + chemotherapy

Experimental: gem/cis cohort - Durvalumab + chemotherapy


Treatment: Drugs: Durvalumab
Anti- PD-L1 Antibody.

Treatment: Drugs: Methotrexate
Chemotherapy agent.

Treatment: Drugs: Vinblastine
Chemotherapy agent

Treatment: Drugs: Doxorubicin
Chemotherapy agent

Treatment: Drugs: Cisplatin
Chemotherapy agent

Treatment: Drugs: Durvalumab
Anti- PD-L1 Antibody

Treatment: Drugs: Gemcitabine
Chemotherapy agent

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

Outcomes
Primary outcome [1] 0 0
The safety of neoadjuvant durvalumab combined with ddMVAC or gem/cis prior to radical cystectomy (RC).
Timepoint [1] 0 0
Up to 6 months
Secondary outcome [1] 0 0
The safety and tolerability of perioperative durvalumab combined with ddMVAC or gem/cis.
Timepoint [1] 0 0
Up to 2 years
Secondary outcome [2] 0 0
The efficacy of perioperative durvalumab combined with ddMVAC or gem/cis in terms of event-free survival (EFS).
Timepoint [2] 0 0
Up to 3 years
Secondary outcome [3] 0 0
The efficacy of perioperative durvalumab combined with ddMVAC or gem/cis in terms of disease-free survival (DFS).
Timepoint [3] 0 0
Up to 3 years
Secondary outcome [4] 0 0
The efficacy of perioperative durvalumab combined with ddMVAC or gem/cis in terms of OS.
Timepoint [4] 0 0
Up to 3 years
Secondary outcome [5] 0 0
The efficacy of neoadjuvant durvalumab combined with ddMVAC or gem/cis followed by RC in terms of pathologic complete response (pCR).
Timepoint [5] 0 0
Up to 3 years
Secondary outcome [6] 0 0
The efficacy of neoadjuvant durvalumab combined with ddMVAC or gem/cis followed by RC in terms of pathologic downstaging (pDS).
Timepoint [6] 0 0
Up to 3 years

Eligibility
Key inclusion criteria
* Participants with clinical tumour stage T2-T4aN0/1M0 or T1N1M0 with transitional or mixed transitional cell histology
* Patients must be planning to undergo radical cystectomy
* Patients who have not received prior systemic chemotherapy or immunotherapy for treatment of muscle-invasive bladder cancer
* ECOG performance status of 0 or 1
* Minimum life expectancy of 12 weeks at first dose of study medication
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Exclusion criteria:

* Evidence of lymph node (N2-N3) or metastatic (M1) disease
* Inoperable tumour(s) with fixation to the pelvic wall on clinical examination
* Prior exposure to immune-mediated therapy including, but not limited to, other anti CTLA-4, anti-PD 1, anti-PD L1 and anti-PD-L2 antibodies, excluding Bacillus Calmette-Guérin
* Current or prior use of immunosuppressive medication within 14 days before the first dose of durvalumab
* Any concomitant medication known to be contraindicated to the chemotherapy (ddMVAC or gem/cis).
* Uncontrolled intercurrent illness.

Study design
Purpose of the study
Treatment
Allocation to intervention
Not applicable
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
Single group
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
30/04/2025
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
31/10/2028
Actual
Sample size
Target
150
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
Research Site - Chermside
Recruitment hospital [2] 0 0
Research Site - Elizabeth Vale
Recruitment hospital [3] 0 0
Research Site - Heidelberg
Recruitment hospital [4] 0 0
Research Site - Kogarah
Recruitment hospital [5] 0 0
Research Site - Macquarie University
Recruitment hospital [6] 0 0
Research Site - Murdoch
Recruitment hospital [7] 0 0
Research Site - Port Macquarie
Recruitment hospital [8] 0 0
Research Site - St Leonards
Recruitment postcode(s) [1] 0 0
4032 - Chermside
Recruitment postcode(s) [2] 0 0
5112 - Elizabeth Vale
Recruitment postcode(s) [3] 0 0
3084 - Heidelberg
Recruitment postcode(s) [4] 0 0
2217 - Kogarah
Recruitment postcode(s) [5] 0 0
2109 - Macquarie University
Recruitment postcode(s) [6] 0 0
6150 - Murdoch
Recruitment postcode(s) [7] 0 0
2444 - Port Macquarie
Recruitment postcode(s) [8] 0 0
2065 - St Leonards
Recruitment outside Australia
Country [1] 0 0
Brazil
State/province [1] 0 0
Barretos
Country [2] 0 0
Brazil
State/province [2] 0 0
Porto Alegre
Country [3] 0 0
Brazil
State/province [3] 0 0
Santo Andre
Country [4] 0 0
Brazil
State/province [4] 0 0
Sao Paulo
Country [5] 0 0
Canada
State/province [5] 0 0
Ontario
Country [6] 0 0
Canada
State/province [6] 0 0
Quebec
Country [7] 0 0
France
State/province [7] 0 0
Angers
Country [8] 0 0
France
State/province [8] 0 0
Bordeaux Cedex
Country [9] 0 0
France
State/province [9] 0 0
Chambray-lès-Tours
Country [10] 0 0
France
State/province [10] 0 0
Dijon
Country [11] 0 0
France
State/province [11] 0 0
Lille
Country [12] 0 0
France
State/province [12] 0 0
Lyon
Country [13] 0 0
France
State/province [13] 0 0
Marseille
Country [14] 0 0
France
State/province [14] 0 0
Montpellier
Country [15] 0 0
France
State/province [15] 0 0
Nice Cedex 2
Country [16] 0 0
France
State/province [16] 0 0
Nimes
Country [17] 0 0
France
State/province [17] 0 0
Paris cedex 15
Country [18] 0 0
France
State/province [18] 0 0
Pierre Benite
Country [19] 0 0
France
State/province [19] 0 0
Poitiers
Country [20] 0 0
France
State/province [20] 0 0
Quint-Fonsegrives
Country [21] 0 0
France
State/province [21] 0 0
Rennes
Country [22] 0 0
France
State/province [22] 0 0
Rouen
Country [23] 0 0
France
State/province [23] 0 0
Strasbourg
Country [24] 0 0
France
State/province [24] 0 0
Suresnes
Country [25] 0 0
Italy
State/province [25] 0 0
Firenze
Country [26] 0 0
Italy
State/province [26] 0 0
Orbassano
Country [27] 0 0
Italy
State/province [27] 0 0
Roma
Country [28] 0 0
Netherlands
State/province [28] 0 0
Amsterdam
Country [29] 0 0
Netherlands
State/province [29] 0 0
Rotterdam
Country [30] 0 0
Spain
State/province [30] 0 0
Barcelona
Country [31] 0 0
Spain
State/province [31] 0 0
Gerona
Country [32] 0 0
Spain
State/province [32] 0 0
Las Palmas de Gran Canaria
Country [33] 0 0
Spain
State/province [33] 0 0
Lugo
Country [34] 0 0
Spain
State/province [34] 0 0
Madrid
Country [35] 0 0
Spain
State/province [35] 0 0
Santiago de Compostela

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
AstraZeneca Clinical Study Information Center
Address 0 0
Country 0 0
Phone 0 0
1-877-240-9479
Fax 0 0
Email 0 0
[email protected]
Contact person for scientific queries

Data sharing statement


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/NCT06960577