NCT06960577

Perioperative Durvalumab With Neoadjuvant ddMVAC or Gemcitabine/Cisplatin in Patients 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)

• Status: Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 150 (estimated)
• Sponsor: AstraZeneca · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

Not provided

Conditions

• Urinary Bladder Neoplasms
• Immune Checkpoint Inhibitors
• Methotrexate
• Vinblastine
• Doxorubicin
• Cisplatin
• Gemcitabine

Interventions

Type	Name	Description
DRUG	Durvalumab	Anti- PD-L1 Antibody.
DRUG	Methotrexate	Chemotherapy agent.
DRUG	Vinblastine	Chemotherapy agent
DRUG	Doxorubicin	Chemotherapy agent
DRUG	Cisplatin	Chemotherapy agent
DRUG	Durvalumab	Anti- PD-L1 Antibody
DRUG	Gemcitabine	Chemotherapy agent
DRUG	Cisplatin	Chemotherapy agent

Timeline

• Start date: 2025-05-15
• Primary completion: 2028-10-31
• Completion: 2028-10-31
• First posted: 2025-05-07
• Last updated: 2026-03-30

Locations

59 sites across 7 countries: Australia, Brazil, Canada, France, Italy, Netherlands, Spain

Regulatory

• FDA-regulated drug study