Perioperative Durvalumab With Neoadjuvant ddMVAC or Gemcitabine/Cisplatin in Patients With Muscle-invasive Bladder Cancer (NIAGARA-2)
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)
1 other identifier
interventional
150
7 countries
59
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_3
Started May 2025
Typical duration for phase_3
59 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 29, 2025
CompletedFirst Posted
Study publicly available on registry
May 7, 2025
CompletedStudy Start
First participant enrolled
May 15, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 31, 2028
ExpectedStudy Completion
Last participant's last visit for all outcomes
October 31, 2028
June 11, 2026
June 1, 2026
3.5 years
April 29, 2025
June 10, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
The safety of neoadjuvant durvalumab combined with ddMVAC or gem/cis prior to radical cystectomy (RC).
Incidence of Grade 3 or 4 \[possibly treatment-related adverse events (PRAEs)\] as observed prior to RC.
Up to 6 months
Secondary Outcomes (6)
The safety and tolerability of perioperative durvalumab combined with ddMVAC or gem/cis.
Up to 2 years
The efficacy of perioperative durvalumab combined with ddMVAC or gem/cis in terms of event-free survival (EFS).
Up to 3 years
The efficacy of perioperative durvalumab combined with ddMVAC or gem/cis in terms of disease-free survival (DFS).
Up to 3 years
The efficacy of perioperative durvalumab combined with ddMVAC or gem/cis in terms of OS.
Up to 3 years
The efficacy of neoadjuvant durvalumab combined with ddMVAC or gem/cis followed by RC in terms of pathologic complete response (pCR).
Up to 3 years
- +1 more secondary outcomes
Study Arms (2)
ddMVAC cohort
EXPERIMENTALDurvalumab + chemotherapy
gem/cis cohort
EXPERIMENTALDurvalumab + chemotherapy
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- AstraZenecalead
Study Sites (59)
Research Site
Chermside, 4032, Australia
Research Site
Elizabeth Vale, 5112, Australia
Research Site
Heidelberg, 3084, Australia
Research Site
Hong Kong, Australia
Research Site
Kogarah, 2217, Australia
Research Site
Macquarie University, 2109, Australia
Research Site
Murdoch, 6150, Australia
Research Site
Port Macquarie, 2444, Australia
Research Site
St Leonards, 2065, Australia
Research Site
Barretos, 14784-400, Brazil
Research Site
Jaú, 17210-080, Brazil
Research Site
Natal, 59075-740, Brazil
Research Site
Porto Alegre, 91350-200, Brazil
Research Site
Rio de Janeiro, 20230-130, Brazil
Research Site
Santo André, 09060-650, Brazil
Research Site
São José do Rio Preto, 15090-000, Brazil
Research Site
São Paulo, 01246-000, Brazil
Research Site
Hamilton, Ontario, L8V 5C2, Canada
Research Site
London, Ontario, N6A 5W9, Canada
Research Site
Ottawa, Ontario, K1H 8L6, Canada
Research Site
Montreal, Quebec, H3T 1E2, Canada
Research Site
Québec, Quebec, G1J 1Z4, Canada
Research Site
Sherbrooke, Quebec, J1H 5N4, Canada
Research Site
Angers, 49055, France
Research Site
Angers, 49933, France
Research Site
Bordeaux, 33075, France
Research Site
Chambray-lès-Tours, 37170, France
Research Site
Dijon, 21079, France
Research Site
Lille, 59037, France
Research Site
Lyon, 69008, France
Research Site
Marseille, 13009, France
Research Site
Montpellier, 34070, France
Research Site
Nice, 06189, France
Research Site
Nîmes, 30029, France
Research Site
Paris, 75010, France
Research Site
Paris, 75900, France
Research Site
Pierre-Bénite, 69310, France
Research Site
Poitiers, 86021, France
Research Site
Quint-Fonsegrives, 31130, France
Research Site
Rennes, 35000, France
Research Site
Rouen, 76230, France
Research Site
Strasbourg, 67033, France
Research Site
Suresnes, 92150, France
Research Site
Florence, 50139, Italy
Research Site
Orbassano, 10043, Italy
Research Site
Roma, 00144, Italy
Research Site
Amsterdam, 1066CX, Netherlands
Research Site
Nijmegen, 6500 HB, Netherlands
Research Site
Rotterdam, 3015 GD, Netherlands
Research Site
Barcelona, 08025, Spain
Research Site
Barcelona, 08035, Spain
Research Site
Barcelona, 08036, Spain
Research Site
Barcelona, 8003, Spain
Research Site
Girona, 17007, Spain
Research Site
Las Palmas de Gran Canaria, 35016, Spain
Research Site
Lugo, 27003, Spain
Research Site
Madrid, 28033, Spain
Research Site
Madrid, 28040, Spain
Research Site
Santiago de Compostela, 15706, Spain
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Central Study Contacts
AstraZeneca Clinical Study Information Center
CONTACT
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 29, 2025
First Posted
May 7, 2025
Study Start
May 15, 2025
Primary Completion (Estimated)
October 31, 2028
Study Completion (Estimated)
October 31, 2028
Last Updated
June 11, 2026
Record last verified: 2026-06
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP
- Time Frame
- AstraZeneca will meet or exceed data availability as per the commitments made to the EFPIA PhRMA Data Sharing Principles. For details of our timelines, please refer to our disclosure commitment at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
- Access Criteria
- When a request has been approved AstraZeneca will provide access to the anonymized individual patient-level data via secure research environment Vivli.org. Signed Data Usage Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information.
Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal Vivli.org. All requests will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure. Yes, indicates that AZ are accepting requests for IPD, but this does not mean all requests will be shared.