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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
Date last updated
25/06/2025
Titles & IDs
Public title
Perioperative Durvalumab With Neoadjuvant ddMVAC or Gemcitabine/Cisplatin in Patients With Muscle-invasive Bladder Cancer (NIAGARA-2)
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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)
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Secondary ID [1]
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D933RC00002
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Urinary Bladder Neoplasms
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Immune Checkpoint Inhibitors
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Methotrexate
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Vinblastine
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Doxorubicin
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Cisplatin
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Gemcitabine
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Condition category
Condition code
Cancer
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Bladder - transitional cell cancer
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Intervention/exposure
Study type
Interventional
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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
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Intervention code [1]
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Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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The safety of neoadjuvant durvalumab combined with ddMVAC or gem/cis prior to radical cystectomy (RC).
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Assessment method [1]
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Incidence of Grade 3 or 4 \[possibly treatment-related adverse events (PRAEs)\] as observed prior to RC.
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Timepoint [1]
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Up to 6 months
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Secondary outcome [1]
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The safety and tolerability of perioperative durvalumab combined with ddMVAC or gem/cis.
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Assessment method [1]
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Incidence, severity, nature, seriousness, intervention/treatment, outcome, and causality of treatment-emergent adverse events, including PRAEs, adverse events of special interest, immune-mediated adverse events, adverse events (AEs), and serious adverse events; AEs resulting in study treatment interruption and discontinuation; laboratory findings.
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Timepoint [1]
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Up to 2 years
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Secondary outcome [2]
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The efficacy of perioperative durvalumab combined with ddMVAC or gem/cis in terms of event-free survival (EFS).
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Assessment method [2]
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EFS is defined as the time from first neoadjuvant durvalumab + chemotherapy treatment until the earliest occurrence of any of the following events: * First recurrence of disease after RC * First documented progression in participants who were medically precluded from RC * Time of expected surgery in participants who refuse to undergo RC or failure to undergo RC in participants with residual disease * Death due to any cause.
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Timepoint [2]
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Up to 3 years
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Secondary outcome [3]
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The efficacy of perioperative durvalumab combined with ddMVAC or gem/cis in terms of disease-free survival (DFS).
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Assessment method [3]
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DFS is defined as the time from the date of RC to the earliest of the first recurrence of disease post RC or death due to any cause.
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Timepoint [3]
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Up to 3 years
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Secondary outcome [4]
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The efficacy of perioperative durvalumab combined with ddMVAC or gem/cis in terms of OS.
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Assessment method [4]
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OS is defined as the time from first neoadjuvant durvalumab + chemotherapy until death due to any cause.
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Timepoint [4]
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Up to 3 years
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Secondary outcome [5]
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The efficacy of neoadjuvant durvalumab combined with ddMVAC or gem/cis followed by RC in terms of pathologic complete response (pCR).
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Assessment method [5]
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pCR rate is defined as the proportion of participants whose pathologic staging is T0N0M0 as assessed per local pathology review using specimens obtained via RC.
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Timepoint [5]
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Up to 3 years
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Secondary outcome [6]
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The efficacy of neoadjuvant durvalumab combined with ddMVAC or gem/cis followed by RC in terms of pathologic downstaging (pDS).
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Assessment method [6]
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pDS rate is defined as the proportion of participants whose pathologic staging is \
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Timepoint [6]
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Up to 3 years
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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
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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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.
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Not applicable
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Single group
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Other design features
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Phase
Phase 3
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Recruiting
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
15/05/2025
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
31/10/2028
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Actual
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Sample size
Target
150
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
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Recruitment hospital [1]
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Research Site - Chermside
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Recruitment hospital [2]
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Research Site - Elizabeth Vale
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Recruitment hospital [3]
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Research Site - Heidelberg
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Recruitment hospital [4]
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Research Site - Hong Kong
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Recruitment hospital [5]
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Research Site - Kogarah
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Recruitment hospital [6]
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Research Site - Macquarie University
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Recruitment hospital [7]
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Research Site - Murdoch
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Recruitment hospital [8]
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Research Site - Port Macquarie
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Recruitment hospital [9]
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Research Site - St Leonards
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Recruitment postcode(s) [1]
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4032 - Chermside
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Recruitment postcode(s) [2]
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5112 - Elizabeth Vale
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Recruitment postcode(s) [3]
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3084 - Heidelberg
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Recruitment postcode(s) [4]
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- Hong Kong
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Recruitment postcode(s) [5]
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2217 - Kogarah
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Recruitment postcode(s) [6]
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2109 - Macquarie University
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Recruitment postcode(s) [7]
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6150 - Murdoch
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Recruitment postcode(s) [8]
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2444 - Port Macquarie
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Recruitment postcode(s) [9]
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2065 - St Leonards
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Recruitment outside Australia
Country [1]
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Brazil
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State/province [1]
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Barretos
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Brazil
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Porto Alegre
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Brazil
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Santo Andre
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Brazil
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Sao Paulo
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Canada
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Ontario
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Canada
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Quebec
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France
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Angers Cedex 02
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France
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Angers
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France
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France
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Chambray-lès-Tours
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France
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Dijon
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France
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Lille
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France
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Lyon
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France
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Marseille
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France
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Montpellier
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France
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Nice Cedex 2
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France
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Nimes
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France
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Paris cedex 15
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France
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Pierre Benite
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France
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Poitiers
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France
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France
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Rennes
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France
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Rouen
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France
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France
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Suresnes
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Italy
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Firenze
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Italy
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Orbassano
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Italy
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Roma
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Amsterdam
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Rotterdam
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Barcelona
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Gerona
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Las Palmas de Gran Canaria
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Spain
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Lugo
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Spain
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Madrid
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Spain
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Santiago de Compostela
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Funding & Sponsors
Primary sponsor type
Commercial sector/industry
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Name
AstraZeneca
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Address
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Country
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Ethics approval
Ethics application status
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Summary
Brief summary
The Phase IIIb NIAGARA-2 study aims to expand on the data from the Phase III NIAGARA study by investigating perioperative durvalumab in combination with investigator-selected cisplatin-based neoadjuvant chemotherapy (either ddMVAC or gemcitabine/cisplatin) in a clinical practice setting.
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Trial website
https://clinicaltrials.gov/study/NCT06960577
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Address
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Email
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Contact person for public queries
Name
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AstraZeneca Clinical Study Information Center
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Address
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Phone
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1-877-240-9479
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Fax
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Email
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[email protected]
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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
Download to PDF