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

NCT06960577

RecruitingPhase 3

Sponsor: AstraZeneca

Conditions: Urinary Bladder Neoplasms, Immune Checkpoint Inhibitors, Methotrexate, Vinblastine, Doxorubicin

Interventions: Durvalumab, Methotrexate, Vinblastine, Doxorubicin, Cisplatin

Countries: Australia, Brazil, Canada, France, Italy, Netherlands, Spain

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 overview

Sex: ALL

Age: 18 Years to —

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility criteria

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.

Locations (59)

Chermside, Australia
Elizabeth Vale, Australia
Heidelberg, Australia
Hong Kong, Australia
Kogarah, Australia
Macquarie University, Australia
Murdoch, Australia
Port Macquarie, Australia
St Leonards, Australia
Barretos, Brazil
Jaú, Brazil
Natal, Brazil
Porto Alegre, Brazil
Rio de Janeiro, Brazil
Santo André, Brazil
São José do Rio Preto, Brazil
São Paulo, Brazil
Hamilton, Ontario, Canada
London, Ontario, Canada
Ottawa, Ontario, Canada
Montreal, Quebec, Canada
Québec, Quebec, Canada
Sherbrooke, Quebec, Canada
Angers, France
Angers, France
Bordeaux, France
Chambray-lès-Tours, France
Dijon, France
Lille, France
Lyon, France
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