NILE: This phase III trial is assessing a first line treatment combining immunotherapy and chemotherapy, versus chemotherapy alone, in patients with locally advanced or metastatic urothelial cancerA Phase III, Randomized, Open-Label, Controlled, Multi-Center, Global Study of First-Line Durvalumab in Combination With Standard of Care Chemotherapy and Durvalumab in Combination With Tremelimumab and Standard of Care Chemotherapy Versus Standard of Care Chemotherapy Alone in Patients With Unresectable Locally Advanced or Metastatic Urothelial Cancer

Inclusion

• Patients with histologically or cytologically documented, unresectable, locally advanced or metastatic transitional cell carcinoma (transitional cell and mixed transitional/non-transitional cell histologies) of the urothelium (including renal pelvis, ureters, urinary bladder, and urethra)
• Patients who have not been previously treated with first-line chemotherapy. Patients who have received prior definitive chemoradiation, adjuvant or neoadjuvant treatment for locally advanced disease are eligible provided that progression to locally advanced or metastatic disease has occurred >12 months from the last therapy [for chemoradiation and adjuvant treatment] or >12 months from the last surgery [for neoadjuvant treatment].
• At least 1 lesion, not previously irradiated, that qualifies as a RECIST 1.1 target lesion at baseline.
• World Health Organization (WHO)/Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0 or 1 at enrolment
• Adequate organ and marrow function as defined in the protocol
• Life expectancy ≥12 weeks in the opinion of the investigator
• Evidence of post-menopausal status, or negative urinary or serum pregnancy test for female pre-menopausal patients.