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RecruitingLast updated: 4 September 2025

NIAGARA-2: A phase III study evaluating perioperative anitbody treatment (Durvalumab) with neoadjuvant chemotherapy in people with muscle-invasive bladder cancer (NIAGARA-2).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)

Trial purpose

Medical clipboardCancer treatment

Tumor type

Urinary System Cancers Genitourinary

Age

People18+

Trial acronym

NIAGARA-2

Clinical summary

Summary

This is a phase III study evaluating the effectiveness of an antibody treatment (Durvalumab) in combination with chemotherapy. 

Eligible participants will be divided into two arms based on the chemotherapy regimen. One arm will receive Durvalumab + chemotherapy (Methotrexate, Vinblastine, Doxorubicin, Cisplatin). The other arm will receive Durvalumab + chemotherapy (Gemcitabine, Cisplatin). 

 

Conditions

This trial is treating people with muscle-invasive bladder cancer (NIAGARA-2)

Eligibility

Inclusion

  • 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

  • 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.

Inclusion

  • You have been diagnosed with cancer, but have not received any treatment.

Exclusion

  • You have certain types of non-cancer medical conditions.
  • You have had certain treatments, surgical procedures or drugs.
Message

Clinical trials have complex eligibility criteria, and other criteria may apply for this trial. Ask your doctor about whether this trial could be right for you.

Participating hospitals

Recruiting hospitals

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More information

Trial Identifiers

Information on this page is partially produced from ClinicalTrials.gov *. View further details about this trial on the registry via the links below:

Trial sponsor

AstraZeneca

Scientific Title

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)

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