Who is eligible for clinical trial NCT06960577?

Participants must meet the protocol's inclusion criteria for Urinary Bladder Neoplasms. The stated age range is 18 Years. Confirm all requirements with the study coordinator.

Does clinical trial NCT06960577 provide travel or cost reimbursement?

Check with the site coordinator at the participating facility for travel and lodging stipend availability, and for which routine-care costs are covered.

🏛️ Verified NIH Record • Updated 2026-08-03

Perioperative Durvalumab With Neoadjuvant ddMVAC or Gemcitabine/Cisplatin in Patients With Muscle-invasive Bladder Cancer (NIAGARA-2) (NCT06960577)

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)

🟢 Recruiting Phase3 💊 Investigational Drug / Biologic Sponsor: AstraZeneca

🩺 Plain-English Summary (8th-Grade Level)

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.

Who can join: To join this study, participants generally need to meet the listed inclusion criteria (5 items) and avoid the listed exclusions (7 items).

Location: Research Site — Chermside

Age range: 18 Years

🧪 Interventions in This Study

📋 "Do I Qualify?" — 1-Minute Self Screener

Instant Checklist

Check every box below. If you can check all of them, you may meet the study's basic screening requirements (final eligibility is confirmed by the site team).

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

Usually NOT eligible if any of the following apply:

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.

🔍 Extracted verbatim from the official NIH eligibility criteria. Always confirm with the study coordinator.

📍 All Participating Trial Locations (59 Sites)

Showing the first 25 of 59 sites.

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,
Research Site — St Leonards,
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,
Research Site — Hamilton, Ontario
Research Site — London, Ontario
Research Site — Ottawa, Ontario
Research Site — Montreal, Quebec
Research Site — Québec, Quebec
Research Site — Sherbrooke, Quebec
Research Site — Angers,
Research Site — Angers,

📞 Contact the Study Coordinator

Phone: (877) 240-9479

Email: information.center@astrazeneca.com

Coordinator details come directly from the registered NIH protocol. Confirm the study is still recruiting before traveling.

💰 Cost, Insurance & Patient Rights

100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
Voluntary Participation: You may withdraw at any time without affecting your standard medical care.

More studies in Urinary Bladder Neoplasms

A Study of TAR-200 in Combination With Cetrelimab Versus Concurrent Chemoradiotherapy in Participants With Muscle-invasive Bladder Cancer (MIBC) of the Bladder — Loma Linda, California
A Study to Compare Chemotherapy Alone Versus Chemotherapy Plus Nivolumab or Nivolumab and BMS-986205, Followed by Continued Therapy After Surgery With Nivolumab or Nivolumab and BMS-986205 in Participants With Muscle Invasive Bladder Cancer — Tucson, Arizona
A Clinical Study of Intismeran Autogene (V940) and BCG in People With Bladder Cancer (V940-011/INTerpath-011) — Bakersfield, California
A Study of Durvalumab Alone and Durvalumab+Olaparib in Advanced, Platinum-Ineligible Bladder Cancer (BAYOU) — Birmingham, Alabama
Efficacy and Safety of Pembrolizumab (MK-3475) in Combination With Chemoradiotherapy (CRT) Versus CRT Alone in Muscle-invasive Bladder Cancer (MIBC) (MK-3475-992/KEYNOTE-992) — Washington D.C., District of Columbia

Explore by condition: All Urinary Bladder Neoplasms clinical trials

💡 How to Participate

Check the checklist above to see if you may qualify.
Contact the study coordinator using the phone/email above.
Ask about the visit schedule, what is covered at no cost, and any travel support.
Confirm with your own doctor before making a decision.

🏛️ View Official NIH Record ↗