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New treatment option for Urinary Bladder Neoplasms
Official title Perioperative Durvalumab With Neoadjuvant ddMVAC or Gemcitabine/Cisplatin in Patients With Muscle-invasive Bladder Cancer (NIAGARA-2)
ClinicalTrials.gov ID: NCT06960577
What this study is testing
What is Durvalumab?
Durvalumab is an investigational medicine, being studied as a potential treatment for urinary bladder neoplasms.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 3: a large, late-stage study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- 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
You likely can't join if
- 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...
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Chermside, Australia
- Elizabeth Vale, Australia
- Heidelberg, Australia
- Hong Kong, Australia
- Kogarah, Australia
- Macquarie University, Australia
- Murdoch, Australia
- Port Macquarie, Australia
- St Leonards, Australia
- Barretos, Brazil
- Jaú, Brazil
- Natal, Brazil
- Porto Alegre, Brazil
- Rio de Janeiro, Brazil
- Santo André, Brazil
- São José do Rio Preto, Brazil
- São Paulo, Brazil
- Hamilton, Ontario, Canada
- London, Ontario, Canada
- Ottawa, Ontario, Canada
+ 33 more site(s).
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Chermside, Australia; Elizabeth Vale, Australia; Heidelberg, Australia; Hong Kong, Australia; Kogarah, Australia; Macquarie University, Australia and 47 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.