Perioperative Durvalumab With Neoadjuvant ddMVAC or Gemcitabine/Cisplatin in Patients With Muscle-invasive Bladder Cancer (NIAGARA-2)

NCT06960577 · tracked via the Priya Life Science Canada tracker

Sponsor

AstraZeneca

Phase

Phase 3

Started

2025-05-15

Last updated

2026-08-04

Condition(s) studied

Urinary Bladder NeoplasmsImmune Checkpoint InhibitorsMethotrexateVinblastineDoxorubicinCisplatinGemcitabine

Investigational drug(s) / intervention(s)

Durvalumab →Methotrexate →Vinblastine →Doxorubicin →Cisplatin →Durvalumab →Gemcitabine →Cisplatin →

Durvalumab: Anti- PD-L1 Antibody.

Methotrexate: Chemotherapy agent.

Vinblastine: Chemotherapy agent

Doxorubicin: Chemotherapy agent

Cisplatin: Chemotherapy agent

Durvalumab: Anti- PD-L1 Antibody

Gemcitabine: Chemotherapy agent

Cisplatin: Chemotherapy agent

Study 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.

Eligibility

Sex

ALL

Min age

18 Years

Max age

—

Healthy volunteers

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 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.

Primary outcome measure(s)

The safety of neoadjuvant durvalumab combined with ddMVAC or gem/cis prior to radical cystectomy (RC). — Up to 6 months
Incidence of Grade 3 or 4 \[possibly treatment-related adverse events (PRAEs)\] as observed prior to RC.

Trial sites (59)

Facility	City	Region	Status
Research Site	Chermside	Australia	Recruiting
Research Site	Elizabeth Vale	Australia	Recruiting
Research Site	Heidelberg	Australia	Recruiting
Research Site	Hong Kong	Australia	Recruiting
Research Site	Kogarah	Australia	Recruiting
Research Site	Macquarie University	Australia	Recruiting
Research Site	Murdoch	Australia	Recruiting
Research Site	Port Macquarie	Australia	Withdrawn
Research Site	St Leonards	Australia	Recruiting
Research Site	Barretos	Brazil	Recruiting
Research Site	Jaú	Brazil	Withdrawn
Research Site	Natal	Brazil	Withdrawn
Research Site	Porto Alegre	Brazil	Recruiting
Research Site	Rio de Janeiro	Brazil	Withdrawn
Research Site	Santo André	Brazil	Recruiting
Research Site	São José do Rio Preto	Brazil	Withdrawn
Research Site	São Paulo	Brazil	Recruiting
Research Site	Hamilton	Ontario	Recruiting
Research Site	London	Ontario	Not Yet Recruiting
Research Site	Ottawa	Ontario	Withdrawn
Research Site	Montreal	Quebec	Not Yet Recruiting
Research Site	Québec	Quebec	Recruiting
Research Site	Sherbrooke	Quebec	Recruiting
Research Site	Angers	France	Not Yet Recruiting
Research Site	Angers	France	Withdrawn
Research Site	Bordeaux	France	Not Yet Recruiting
Research Site	Chambray-lès-Tours	France	Recruiting
Research Site	Dijon	France	Withdrawn
Research Site	Lille	France	Recruiting
Research Site	Lyon	France	Recruiting
Research Site	Marseille	France	Recruiting
Research Site	Montpellier	France	Recruiting
Research Site	Nice	France	Recruiting
Research Site	Nîmes	France	Recruiting
Research Site	Paris	France	Recruiting
Research Site	Paris	France	Recruiting
Research Site	Pierre-Bénite	France	Not Yet Recruiting
Research Site	Poitiers	France	Recruiting
Research Site	Quint-Fonsegrives	France	Recruiting
Research Site	Rennes	France	Recruiting

+ 19 more sites — see the full list on the official registry below.

On this site

📄 Imfinzi (durvalumab) drug profile →

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06960577 on ClinicalTrials.gov ↗ ← All trials in Canada