Recruiting NCT06960577
Perioperative Durvalumab With Neoadjuvant ddMVAC or Gemcitabine/Cisplatin in Patients With Muscle-invasive Bladder Cancer (NIAGARA-2)
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Durvalumab, Methotrexate, Vinblastine, Doxorubicin.
- Who it may be relevant to
- Registry conditions: Urinary Bladder Neoplasms, Immune Checkpoint Inhibitors, Methotrexate, Vinblastine. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Australia, Brazil, Canada, France, Italy +2
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
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)
Overview
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
Interventions
- Drug Durvalumab
Anti- PD-L1 Antibody. - Drug Methotrexate
Chemotherapy agent. - Drug Vinblastine
Chemotherapy agent - Drug Doxorubicin
Chemotherapy agent - Drug Cisplatin
Chemotherapy agent - Drug Durvalumab
Anti- PD-L1 Antibody - Drug Gemcitabine
Chemotherapy agent - Drug Cisplatin
Chemotherapy agent
Primary outcome measures
- The safety of neoadjuvant durvalumab combined with ddMVAC or gem/cis prior to radical cystectomy (RC). [Time frame: Up to 6 months]
Secondary outcome measures (6)
- The safety and tolerability of perioperative durvalumab combined with ddMVAC or gem/cis. [Time frame: Up to 2 years]
- The efficacy of perioperative durvalumab combined with ddMVAC or gem/cis in terms of event-free survival (EFS). [Time frame: Up to 3 years]
- The efficacy of perioperative durvalumab combined with ddMVAC or gem/cis in terms of disease-free survival (DFS). [Time frame: Up to 3 years]
- The efficacy of perioperative durvalumab combined with ddMVAC or gem/cis in terms of OS. [Time frame: 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). [Time frame: Up to 3 years]
- The efficacy of neoadjuvant durvalumab combined with ddMVAC or gem/cis followed by RC in terms of pathologic downstaging (pDS). [Time frame: Up to 3 years]
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
France · 20 centers
- Research Site — Angers
- Research Site — Angers
- Research Site — Bordeaux
- Research Site — Chambray-lès-Tours
- Research Site — Dijon
- Research Site — Lille
- Research Site — Lyon
- Research Site — Marseille
- … and 12 more centers
Spain · 10 centers
- Research Site — Barcelona
- Research Site — Barcelona
- Research Site — Barcelona
- Research Site — Barcelona
- Research Site — Girona
- Research Site — Las Palmas de Gran Canaria
- Research Site — Lugo
- Research Site — Madrid
- … and 2 more centers
Australia · 9 centers
- Research Site — Chermside
- Research Site — Elizabeth Vale
- Research Site — Heidelberg
- Research Site — Hong Kong
- Research Site — Kogarah
- Research Site — Macquarie University
- Research Site — Murdoch
- Research Site — Port Macquarie
- … and 1 more center
Brazil · 8 centers
- Research Site — Barretos
- Research Site — Jaú
- Research Site — Natal
- Research Site — Porto Alegre
- Research Site — Rio de Janeiro
- Research Site — Santo André
- Research Site — São José do Rio Preto
- Research Site — São Paulo
Canada · 6 centers
- Research Site — Hamilton
- Research Site — London
- Research Site — Ottawa
- Research Site — Montreal
- Research Site — Québec
- Research Site — Sherbrooke
Italy · 3 centers
- Research Site — Florence
- Research Site — Orbassano
- Research Site — Roma
Netherlands · 3 centers
- Research Site — Amsterdam
- Research Site — Nijmegen
- Research Site — Rotterdam
Identifiers
NCT: NCT06960577 · D933RC00002