RecruitingPhase 3NCT06960577

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)

Sponsor

AstraZeneca

Enrollment

150 participants

Start Date

May 15, 2025

Study Type

INTERVENTIONAL

Conditions

Urinary Bladder Neoplasms Immune Checkpoint Inhibitors Methotrexate Vinblastine Doxorubicin Cisplatin Gemcitabine

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.

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing whether adding a drug called durvalumab (an immunotherapy) to standard chemotherapy before bladder removal surgery improves outcomes for people with muscle-invasive bladder cancer. Participants will receive chemotherapy (either ddMVAC or gemcitabine/cisplatin) plus durvalumab before surgery, and the study will track how well the cancer responds. **You may be eligible if...** - You have been diagnosed with muscle-invasive bladder cancer (stages T2–T4a or T1N1) with transitional cell type - You are planning to have your bladder surgically removed (radical cystectomy) - You have not previously received chemotherapy or immunotherapy for this bladder cancer - You are in good general health (ECOG 0 or 1) with a life expectancy of at least 12 weeks **You may NOT be eligible if...** - Your cancer has spread to multiple lymph nodes or other organs - Your tumor is stuck to the pelvic wall and cannot be surgically removed - You have previously been treated with immune checkpoint therapies (like anti-PD-1 or anti-CTLA-4 drugs) - You are currently taking immunosuppressive medication - You have other serious uncontrolled medical conditions Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGDurvalumab

Anti- PD-L1 Antibody.

DRUGMethotrexate

Chemotherapy agent.

DRUGVinblastine

Chemotherapy agent

DRUGDoxorubicin

Chemotherapy agent

DRUGCisplatin

Chemotherapy agent

DRUGDurvalumab

Anti- PD-L1 Antibody

DRUGGemcitabine

Chemotherapy agent

DRUGCisplatin

Chemotherapy agent

Locations(59)

Research Site

Chermside, Australia

Research Site

Elizabeth Vale, Australia

Research Site

Heidelberg, Australia

Research Site

Hong Kong, Australia

Research Site

Kogarah, Australia

Research Site

Macquarie University, Australia

Research Site

Murdoch, Australia

Research Site

Port Macquarie, Australia

Research Site

St Leonards, Australia

Research Site

Barretos, Brazil

Research Site

Jaú, Brazil

Research Site

Natal, Brazil

Research Site

Porto Alegre, Brazil

Research Site

Rio de Janeiro, Brazil

Research Site

Santo André, Brazil

Research Site

São José do Rio Preto, Brazil

Research Site

São Paulo, Brazil

Research Site

Hamilton, Ontario, Canada

Research Site

London, Ontario, Canada

Research Site

Ottawa, Ontario, Canada

Research Site

Montreal, Quebec, Canada

Research Site

Québec, Quebec, Canada

Research Site

Sherbrooke, Quebec, Canada

Research Site

Angers, France

Research Site

Angers, France

Research Site

Bordeaux, France

Research Site

Chambray-lès-Tours, France

Research Site

Dijon, France

Research Site

Lille, France

Research Site

Lyon, France

Research Site

Marseille, France

Research Site

Montpellier, France

Research Site

Nice, France

Research Site

Nîmes, France

Research Site

Paris, France

Research Site

Paris, France

Research Site

Pierre-Bénite, France

Research Site

Poitiers, France

Research Site

Quint-Fonsegrives, France

Research Site

Rennes, France

Research Site

Rouen, France

Research Site

Strasbourg, France

Research Site

Suresnes, France

Research Site

Florence, Italy

Research Site

Orbassano, Italy

Research Site

Roma, Italy

Research Site

Amsterdam, Netherlands

Research Site

Nijmegen, Netherlands

Research Site

Rotterdam, Netherlands

Research Site

Barcelona, Spain

Research Site

Barcelona, Spain

Research Site

Barcelona, Spain

Research Site

Barcelona, Spain

Research Site

Girona, Spain

Research Site

Las Palmas de Gran Canaria, Spain

Research Site

Lugo, Spain

Research Site

Madrid, Spain

Research Site

Madrid, Spain

Research Site

Santiago de Compostela, Spain

View Full Details on ClinicalTrials.gov

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NCT06960577

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