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Using durvalumab with chemotherapy for muscle-invasive bladder cancer

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)

Phase 3 Interventional AstraZeneca · NCT06960577

This study is testing if adding a new immune therapy called durvalumab to standard chemotherapy can help people with muscle-invasive bladder cancer before they have surgery.

Quick facts

PhasePhase 3
Study typeInterventional
Enrollment150 (estimated)
Ages18 Years and up
SexAll
SponsorAstraZeneca Industry-sponsored
Drugs / interventionsdurvalumab, chemotherapy, immunotherapy
Locations59 sites (Chermside and 58 other locations)
Trial IDNCT06960577 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Ideal candidates are patients with clinical tumor stage T2-T4aN0/1M0 or T1N1M0 who are planning to undergo radical cystectomy and have not received prior systemic chemotherapy or immunotherapy.

Not a fit: Patients with evidence of advanced lymph node or metastatic disease, or those who have previously received immune-mediated therapy, may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could improve outcomes for patients with muscle-invasive bladder cancer by enhancing the effectiveness of chemotherapy through immunotherapy.

How similar studies have performed: Other studies have shown promise with similar approaches using immune checkpoint inhibitors in combination with chemotherapy, indicating potential for success.

Eligibility criteria

Show full inclusion / exclusion 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.

Where this trial is running

Chermside and 58 other locations

+9 more sites — see ClinicalTrials.gov for the full list.

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Urinary Bladder NeoplasmsImmune Checkpoint InhibitorsMethotrexateVinblastineDoxorubicinCisplatinGemcitabineMuscle-invasive Bladder Cancer
Last reviewed 2026-06-13 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.