RECRUITINGPhase 3INTERVENTIONAL
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)
About This Trial
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.
Who May Be Eligible (Plain English)
Who May Qualify:
- 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
- You should be able to carry out daily activities with 0 level of ability (ECOG 0) or 1
- Minimum life expectancy of 12 weeks at first dose of study medication
Who Should NOT Join This Trial:
- 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.
Always talk to your doctor about whether this trial is right for you.
Original Eligibility Criteria
View original clinical language
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.
Treatments Being Tested
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
Locations (20)
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