Actively Recruiting
A Phase IIIb, Open-label, Single-arm, Global Study of Perioperative Durvalumab With Neoadjuvant ddMVAC or Gemcitabine/Cisplatin in Patients With Muscle-invasive Bladder Cancer (NIAGARA-2)
Led by AstraZeneca · Updated on 2026-04-23
150
Participants Needed
59
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating perioperative durvalumab combined with investigator-selected cisplatin-based neoadjuvant chemotherapy in patients with muscle-invasive bladder cancer. This Phase IIIb study, known as NIAGARA-2, expands on previous research by assessing this treatment combination in a real-world clinical practice setting. The primary focus is to understand the safety and effectiveness of adding durvalumab to chemotherapy before surgery. Participants receive durvalumab alongside one of two chemotherapy regimens chosen by their doctor: ddMVAC (which includes methotrexate, vinblastine, doxorubicin, and cisplatin) or gemcitabine with cisplatin. This combination is given prior to radical cystectomy surgery. The study is open-label and does not include a placebo group. During the study, participants will be closely monitored for safety and treatment effects for up to three years. Assessments include tracking side effects, event-free survival, disease-free survival, overall survival, and responses observed after surgery such as complete response or tumor downstaging. The main safety evaluation occurs within six months, with extended follow-up to capture longer-term outcomes and tolerability.
CONDITIONS
Brief Title
Perioperative Durvalumab With Neoadjuvant ddMVAC or Gemcitabine/Cisplatin in Patients With Muscle-invasive Bladder Cancer (NIAGARA-2)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Participants with clinical tumour stage T2-T4aN0/1M0 or T1N1M0 with transitional or mixed transitional cell histology
- Patients planning to undergo radical cystectomy
- No prior systemic chemotherapy or immunotherapy for muscle-invasive bladder cancer
- ECOG performance status of 0 or 1
- Minimum life expectancy of 12 weeks at first dose of study medication
You will not qualify if you...
- Evidence of lymph node (N2-N3) or metastatic (M1) disease
- Inoperable tumour(s) fixed to pelvic wall on clinical exam
- Prior immune-mediated therapy including anti CTLA-4, anti-PD 1, anti-PD L1, and anti-PD-L2 antibodies, excluding Bacillus Calmette-Guérin
- Use of immunosuppressive medication within 14 days before first durvalumab dose
- Use of any medication contraindicated with ddMVAC or gemcitabine/cisplatin chemotherapy
- Uncontrolled intercurrent illness
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 6 months
Participants receive perioperative durvalumab combined with chemotherapy (ddMVAC or gemcitabine/cisplatin) before undergoing radical cystectomy.
Multiple visits during chemotherapy and perioperative period
Duration - Up to 3 years
Participants are monitored for safety, tolerability, and efficacy including event-free survival, disease-free survival, and overall survival for up to 3 years after treatment.
Regular follow-up visits over 3 years
Trial Site Locations
Total: 59 locations
1
Research Site
Chermside, Australia, 4032
Actively Recruiting
2
Research Site
Elizabeth Vale, Australia, 5112
Actively Recruiting
3
Research Site
Heidelberg, Australia, 3084
Actively Recruiting
4
Research Site
Hong Kong, Australia
Actively Recruiting
5
Research Site
Kogarah, Australia, 2217
Actively Recruiting
6
Research Site
Macquarie University, Australia, 2109
Actively Recruiting
7
Research Site
Murdoch, Australia, 6150
Actively Recruiting
8
Research Site
Port Macquarie, Australia, 2444
Actively Recruiting
9
Research Site
St Leonards, Australia, 2065
Actively Recruiting
10
Research Site
Barretos, Brazil, 14784-400
Actively Recruiting
11
Research Site
Jaú, Brazil, 17210-080
Withdrawn
12
Research Site
Natal, Brazil, 59075-740
Withdrawn
13
Research Site
Porto Alegre, Brazil, 91350-200
Actively Recruiting
14
Research Site
Rio de Janeiro, Brazil, 20230-130
Withdrawn
15
Research Site
Santo André, Brazil, 09060-650
Actively Recruiting
16
Research Site
São José do Rio Preto, Brazil, 15090-000
Withdrawn
17
Research Site
São Paulo, Brazil, 01246-000
Actively Recruiting
18
Research Site
Hamilton, Ontario, Canada, L8V 5C2
Actively Recruiting
19
Research Site
London, Ontario, Canada, N6A 5W9
Not Yet Recruiting
20
Research Site
Ottawa, Ontario, Canada, K1H 8L6
Withdrawn
21
Research Site
Montreal, Quebec, Canada, H3T 1E2
Not Yet Recruiting
22
Research Site
Québec, Quebec, Canada, G1J 1Z4
Actively Recruiting
23
Research Site
Sherbrooke, Quebec, Canada, J1H 5N4
Actively Recruiting
24
Research Site
Angers, France, 49055
Not Yet Recruiting
25
Research Site
Angers, France, 49933
Withdrawn
26
Research Site
Bordeaux, France, 33075
Not Yet Recruiting
27
Research Site
Chambray-lès-Tours, France, 37170
Not Yet Recruiting
28
Research Site
Dijon, France, 21079
Not Yet Recruiting
29
Research Site
Lille, France, 59037
Not Yet Recruiting
30
Research Site
Lyon, France, 69008
Not Yet Recruiting
31
Research Site
Marseille, France, 13009
Not Yet Recruiting
32
Research Site
Montpellier, France, 34070
Not Yet Recruiting
33
Research Site
Nice, France, 06189
Not Yet Recruiting
34
Research Site
Nîmes, France, 30029
Not Yet Recruiting
35
Research Site
Paris, France, 75010
Not Yet Recruiting
36
Research Site
Paris, France, 75900
Not Yet Recruiting
37
Research Site
Pierre-Bénite, France, 69310
Not Yet Recruiting
38
Research Site
Poitiers, France, 86021
Not Yet Recruiting
39
Research Site
Quint-Fonsegrives, France, 31130
Not Yet Recruiting
40
Research Site
Rennes, France, 35000
Not Yet Recruiting
41
Research Site
Rouen, France, 76230
Not Yet Recruiting
42
Research Site
Strasbourg, France, 67033
Not Yet Recruiting
43
Research Site
Suresnes, France, 92150
Not Yet Recruiting
44
Research Site
Florence, Italy, 50139
Not Yet Recruiting
45
Research Site
Orbassano, Italy, 10043
Not Yet Recruiting
46
Research Site
Roma, Italy, 00144
Not Yet Recruiting
47
Research Site
Amsterdam, Netherlands, 1066CX
Not Yet Recruiting
48
Research Site
Nijmegen, Netherlands, 6500 HB
Not Yet Recruiting
49
Research Site
Rotterdam, Netherlands, 3015 GD
Not Yet Recruiting
50
Research Site
Barcelona, Spain, 08025
Not Yet Recruiting
51
Research Site
Barcelona, Spain, 08035
Not Yet Recruiting
52
Research Site
Barcelona, Spain, 08036
Not Yet Recruiting
53
Research Site
Barcelona, Spain, 8003
Not Yet Recruiting
54
Research Site
Girona, Spain, 17007
Not Yet Recruiting
55
Research Site
Las Palmas de Gran Canaria, Spain, 35016
Not Yet Recruiting
56
Research Site
Lugo, Spain, 27003
Not Yet Recruiting
57
Research Site
Madrid, Spain, 28033
Not Yet Recruiting
58
Research Site
Madrid, Spain, 28040
Not Yet Recruiting
59
Research Site
Santiago de Compostela, Spain, 15706
Not Yet Recruiting
Research Team
A
AstraZeneca Clinical Study Information Center
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
2
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