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)
Status: Recruiting
Location: See all (59) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 3
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:
• 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
Locations
Other Locations
Australia
Research Site
RECRUITING
Chermside
Research Site
RECRUITING
Elizabeth Vale
Research Site
RECRUITING
Heidelberg
Research Site
RECRUITING
Hong Kong
Research Site
RECRUITING
Kogarah
Research Site
RECRUITING
Macquarie University
Research Site
RECRUITING
Murdoch
Research Site
RECRUITING
Port Macquarie
Research Site
RECRUITING
St Leonards
Brazil
Research Site
RECRUITING
Barretos
Research Site
WITHDRAWN
Jaú
Research Site
WITHDRAWN
Natal
Research Site
RECRUITING
Porto Alegre
Research Site
WITHDRAWN
Rio De Janeiro
Research Site
RECRUITING
Santo André
Research Site
WITHDRAWN
São José Do Rio Preto
Research Site
RECRUITING
São Paulo
Canada
Research Site
RECRUITING
Hamilton
Research Site
NOT_YET_RECRUITING
London
Research Site
NOT_YET_RECRUITING
Montreal
Research Site
WITHDRAWN
Ottawa
Research Site
RECRUITING
Québec
Research Site
RECRUITING
Sherbrooke
France
Research Site
NOT_YET_RECRUITING
Angers
Research Site
WITHDRAWN
Angers
Research Site
NOT_YET_RECRUITING
Bordeaux
Research Site
NOT_YET_RECRUITING
Chambray-lès-tours
Research Site
NOT_YET_RECRUITING
Dijon
Research Site
NOT_YET_RECRUITING
Lille
Research Site
NOT_YET_RECRUITING
Lyon
Research Site
NOT_YET_RECRUITING
Marseille
Research Site
NOT_YET_RECRUITING
Montpellier
Research Site
NOT_YET_RECRUITING
Nice
Research Site
NOT_YET_RECRUITING
Nîmes
Research Site
NOT_YET_RECRUITING
Paris
Research Site
NOT_YET_RECRUITING
Paris
Research Site
NOT_YET_RECRUITING
Pierre-bénite
Research Site
NOT_YET_RECRUITING
Poitiers
Research Site
NOT_YET_RECRUITING
Quint-fonsegrives
Research Site
NOT_YET_RECRUITING
Rennes
Research Site
NOT_YET_RECRUITING
Rouen
Research Site
NOT_YET_RECRUITING
Strasbourg
Research Site
NOT_YET_RECRUITING
Suresnes
Italy
Research Site
NOT_YET_RECRUITING
Florence
Research Site
NOT_YET_RECRUITING
Orbassano
Research Site
NOT_YET_RECRUITING
Roma
Netherlands
Research Site
NOT_YET_RECRUITING
Amsterdam
Research Site
NOT_YET_RECRUITING
Nijmegen
Research Site
NOT_YET_RECRUITING
Rotterdam
Spain
Research Site
NOT_YET_RECRUITING
Barcelona
Research Site
NOT_YET_RECRUITING
Barcelona
Research Site
NOT_YET_RECRUITING
Barcelona
Research Site
NOT_YET_RECRUITING
Barcelona
Research Site
NOT_YET_RECRUITING
Girona
Research Site
NOT_YET_RECRUITING
Las Palmas De Gran Canaria
Research Site
NOT_YET_RECRUITING
Lugo
Research Site
NOT_YET_RECRUITING
Madrid
Research Site
NOT_YET_RECRUITING
Madrid
Research Site
NOT_YET_RECRUITING
Santiago De Compostela
Contact Information
Primary
AstraZeneca Clinical Study Information Center
information.center@astrazeneca.com
1-877-240-9479
Time Frame
Start Date: 2025-05-15
Estimated Completion Date: 2028-10-31
Participants
Target number of participants: 150
Treatments
Experimental: ddMVAC cohort
Durvalumab + chemotherapy
Experimental: gem/cis cohort
Durvalumab + chemotherapy
Related Therapeutic Areas
Sponsors
Leads: AstraZeneca