Last updated 13 days ago
Perioperative Durvalumab With Neoadjuvant ddMVAC or Gemcitabine/Cisplatin in Patients With Muscle-invasive Bladder Cancer (NIAGARA-2)
150 patients around the world
Available in Brazil
Not provided
AstraZeneca
150Patients around the world
This study is for people with
Bladder Cancer
Muscle-Invasive Bladder Cancer
Requirements for the patient
From 18 Years
All Gender
Medical requirements
- 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.
- 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.
SponsorAstraZeneca
Study typeInterventional
Conditions
Muscle-Invasive Bladder Cancer
Requirements
From 18 YearsAll Gender
Unique study IDclinicaltrials.gov
NCT06960577
