Clinical trial NCT06960577: Perioperative Durvalumab With Neoadjuvant ddMVAC or Gemcitabine/Cisplatin in Patients With Muscle-invasive Bladder Cancer (NIAGARA-2)
Official 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)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE3
Conditions: Urinary Bladder Neoplasms
Immune Checkpoint Inhibitors
Methotrexate
Vinblastine
Doxorubicin
Cisplatin
Gemcitabine
Keywords: Muscle-invasive Bladder Cancer
Bladder Cancer
Immunotherapy
Durvalumab
Perioperative Durvalumab
ddMVAC
Gemcitabine
Cisplatin
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2025-05-07
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Detailed description: Not provided

Eligibility criteria: 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 outcomes:
measure: The safety of neoadjuvant durvalumab combined with ddMVAC or gem/cis prior to radical cystectomy (RC).
timeFrame: Up to 6 months
Secondary outcomes:
measure: The safety and tolerability of perioperative durvalumab combined with ddMVAC or gem/cis.
timeFrame: Up to 2 years
measure: The efficacy of perioperative durvalumab combined with ddMVAC or gem/cis in terms of event-free survival (EFS).
timeFrame: Up to 3 years
measure: The efficacy of perioperative durvalumab combined with ddMVAC or gem/cis in terms of disease-free survival (DFS).
timeFrame: Up to 3 years
measure: The efficacy of perioperative durvalumab combined with ddMVAC or gem/cis in terms of OS.
timeFrame: Up to 3 years
measure: The efficacy of neoadjuvant durvalumab combined with ddMVAC or gem/cis followed by RC in terms of pathologic complete response (pCR).
timeFrame: Up to 3 years
measure: The efficacy of neoadjuvant durvalumab combined with ddMVAC or gem/cis followed by RC in terms of pathologic downstaging (pDS).
timeFrame: Up to 3 years
Other outcomes:
Locations:
city: Chermside
country: Australia
facility: Research Site
city: Elizabeth Vale
country: Australia
facility: Research Site
city: Heidelberg
country: Australia
facility: Research Site
city: Hong Kong
country: Australia
facility: Research Site
city: Kogarah
country: Australia
facility: Research Site
city: Macquarie University
country: Australia
facility: Research Site
city: Murdoch
country: Australia
facility: Research Site
city: Port Macquarie
country: Australia
facility: Research Site
city: St Leonards
country: Australia
facility: Research Site
city: Barretos
country: Brazil
facility: Research Site
city: Porto Alegre
country: Brazil
facility: Research Site
city: Santo Andre
country: Brazil
facility: Research Site
city: Sao Paulo
country: Brazil
facility: Research Site
city: Hamilton
country: Canada
facility: Research Site
state: Ontario
city: London
country: Canada
facility: Research Site
state: Ontario
city: Ottawa
country: Canada
facility: Research Site
state: Ontario
city: Sherbrooke
country: Canada
facility: Research Site
state: Quebec
city: Quebec
country: Canada
facility: Research Site
city: Angers
country: France
facility: Research Site
city: Bordeaux Cedex
country: France
facility: Research Site
city: Chambray-lès-Tours
country: France
facility: Research Site
city: Dijon
country: France
facility: Research Site
city: Lille
country: France
facility: Research Site
city: Lyon
country: France
facility: Research Site
city: Marseille
country: France
facility: Research Site
city: Montpellier
country: France
facility: Research Site
city: Nice Cedex 2
country: France
facility: Research Site
city: Nimes
country: France
facility: Research Site
city: Paris cedex 15
country: France
facility: Research Site
city: Pierre Benite
country: France
facility: Research Site
city: Poitiers
country: France
facility: Research Site
city: Quint-Fonsegrives
country: France
facility: Research Site
city: Rennes
country: France
facility: Research Site
city: Rouen
country: France
facility: Research Site
city: Strasbourg
country: France
facility: Research Site
city: Suresnes
country: France
facility: Research Site
city: Firenze
country: Italy
facility: Research Site
city: Orbassano
country: Italy
facility: Research Site
city: Roma
country: Italy
facility: Research Site
city: Amsterdam
country: Netherlands
facility: Research Site
city: Rotterdam
country: Netherlands
facility: Research Site
city: Barcelona
country: Spain
facility: Research Site
city: Barcelona
country: Spain
facility: Research Site
city: Barcelona
country: Spain
facility: Research Site
city: Barcelona
country: Spain
facility: Research Site
city: Gerona
country: Spain
facility: Research Site
city: Las Palmas de Gran Canaria
country: Spain
facility: Research Site
city: Lugo
country: Spain
facility: Research Site
city: Madrid
country: Spain
facility: Research Site
city: Madrid
country: Spain
facility: Research Site
city: Santiago de Compostela
country: Spain
facility: Research Site
Study officials:
References: