Using durvalumab with chemotherapy for muscle-invasive bladder cancer

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

The NIAGARA-2 study is a Phase IIIb clinical trial that investigates the use of durvalumab, an immune checkpoint inhibitor, in combination with neoadjuvant chemotherapy (either ddMVAC or gemcitabine/cisplatin) for patients with muscle-invasive bladder cancer. This study aims to build on previous findings by evaluating the effectiveness of this treatment approach in a real-world clinical setting. Participants will be those planning to undergo radical cystectomy and who have not previously received systemic chemotherapy or immunotherapy for their condition.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Participants with clinical tumour stage T2-T4aN0/1M0 or T1N1M0 with transitional or mixed transitional cell histology
* Participants must be planning to undergo radical cystectomy
* Participants 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 with ddMVAC.
* Uncontrolled intercurrent illness.

Where it's running

• 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

+9 more sites. See ClinicalTrials.gov for the full list.

Study contacts

• Study coordinator: AstraZeneca Clinical Study Information Center
• Email: information.center@astrazeneca.com
• Phone: 1-877-240-9479

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Other studies for the same condition or treatment. Recruiting studies are listed first.

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.