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

Launched by ASTRAZENECA · Apr 29, 2025

Keywords

ClinConnect Summary

The NIAGARA-2 clinical trial is studying a new treatment approach for patients with muscle-invasive bladder cancer. The trial will look at how well a drug called durvalumab works when given alongside standard chemotherapy (either ddMVAC or gemcitabine/cisplatin) before surgery to remove the bladder. This study aims to gather more information on how this combination treatment can help improve outcomes for patients.

To be eligible for this trial, participants should be planning to undergo surgery for their bladder cancer and have not received any prior chemotherapy or immunotherapy treatments for this condition. They should have specific types of cancer staging (T2-T4aN0/1M0 or T1N1M0) and a good performance status, meaning they are still able to carry out daily activities. The trial is not yet recruiting participants, but those who join can expect to receive close monitoring and care as part of the study. It’s also important to note that certain health conditions or previous treatments may prevent someone from participating.

Gender

ALL

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.