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

NCT06960577 · Status: RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 150

Last updated 2026-04-23

No results posted yet for this study

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

Interventions

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

Sponsors & Collaborators

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-05-15
Primary Completion
2028-10-31
Completion
2028-10-31
FDA Drug
Yes

Countries

  • Australia
  • Brazil
  • Canada
  • France
  • Italy
  • Netherlands
  • Spain

Study Locations

More Related Trials

Entities

Drugs
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06960577 on ClinicalTrials.gov