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

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.

Trial Details

NCT ID

NCT06960577

Phase

PHASE3

Sponsor

AstraZeneca

Status

RECRUITING

Cancer Type

Bladder Cancer

Interventions

Durvalumab
Methotrexate
Vinblastine
Doxorubicin
Cisplatin
Gemcitabine

Locations (sample)

Chermside, Australia|-27.38472,153.03062
Elizabeth Vale, Australia|-34.74857,138.66819
Heidelberg, Australia|-37.75,145.06667
Hong Kong, Australia
Kogarah, Australia|-33.9681,151.13564

Key Eligibility 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

For full eligibility, visit ClinicalTrials.gov.

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