Recruiting
Phase 3

Durvalumab & Chemotherapy

Sponsor:

AstraZeneca

Code:

NCT06960577

Conditions

Urinary Bladder Neoplasms

Immune Checkpoint Inhibitors

Methotrexate

Vinblastine

Doxorubicin

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Durvalumab

Methotrexate

Vinblastine

Doxorubicin

Cisplatin

Study Details

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 neoadjuvant chemotherapy (either ddMVAC or gemcitabine/cisplatin) in a clinical practice setting.

Conditions

Urinary Bladder Neoplasms

Immune Checkpoint Inhibitors

Methotrexate

Vinblastine

Doxorubicin

Study ID

NCT06960577

Start date

May 15, 2025

Status verified date

Aug, 2026

Completion date

Oct 31, 2028

Anticipated

Primary completion date

Oct 31, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

150 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: ddMVAC cohort

Durvalumab + chemotherapy

experimental: gem/cis cohort

Durvalumab + chemotherapy

Interventions

Durvalumab

Anti- PD-L1 Antibody.

Methotrexate

Chemotherapy agent.

Vinblastine

Chemotherapy agent

Doxorubicin

Chemotherapy agent

Cisplatin

Chemotherapy agent

Durvalumab

Anti- PD-L1 Antibody

Gemcitabine

Chemotherapy agent

Cisplatin

Chemotherapy agent

Primary outcome measure

  • The safety of neoadjuvant durvalumab combined with ddMVAC or gem/cis prior to radical cystectomy (RC). [ Time Frame: Up to 6 months ]

Central Contacts and Locations

Central contacts

AstraZeneca Clinical Study Information Center

1-877-240-9479information.center@astrazeneca.com

Locations

Research Site

Recruiting

Hamilton, Ontario, Canada, L8V 5C2

Research Site

Recruiting

Québec, Quebec, Canada, G1J 1Z4

Research Site

Recruiting

Sherbrooke, Quebec, Canada, J1H 5N4

More Information

Sponsor

AstraZeneca

Last update posted

Aug 4, 2026

Last verified

Aug, 2026

Keywords

  • Muscle-invasive Bladder Cancer
  • Bladder Cancer
  • Immunotherapy
  • Durvalumab
  • Perioperative Durvalumab
  • ddMVAC
  • Gemcitabine
  • Cisplatin

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by AstraZeneca on 2026-08-04.