Status:
RECRUITING
Perioperative Durvalumab With Neoadjuvant ddMVAC or Gemcitabine/Cisplatin in Patients With Muscle-invasive Bladder Cancer (NIAGARA-2)
Lead Sponsor:
AstraZeneca
Conditions:
Urinary Bladder Neoplasms
Immune Checkpoint Inhibitors
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief 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 neoadjuva...
Detailed Description
Not provided
Eligibility Criteria
Inclusion
- 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.
Exclusion
Key Trial Info
Start Date :
May 15 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
October 31 2028
Estimated Enrollment :
150 Patients enrolled
Trial Details
Trial ID
NCT06960577
Start Date
May 15 2025
End Date
October 31 2028
Last Update
December 17 2025
Active Locations (54)
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1
Research Site
Chermside, Australia, 4032
2
Research Site
Elizabeth Vale, Australia, 5112
3
Research Site
Heidelberg, Australia, 3084
4
Research Site
Hong Kong, Australia