Lay Title: First line therapy with chemotherapy or chemo-immunotherapy combinations in untreated locally advanced or metastatic urothelial cancer
Technical Title: A 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
Disease Type: Metastatic Urothelial cancer
Basic information: The purpose of this study is to compare chemotherapy with chemotherapy in combination with durvalumab or with durvalumab and tremelimumab in patients with metastatic urothelial cancer
Research Procedures (not a complete list): Once patient beggins treatment, they need to come to clinic weekly, 2 weeks on, one week off of a 21day cycle. Duration of treatment depends on the treatment arm. More details upon entering study will be provided.
Eligibility Criteria (not a complete list):
a.Subjects that received neoadjuvant chemotherapy with recurrence >12 months from completion of therapy are permitted.
b.Subjects that received adjuvant chemotherapy following cystectomy with recurrence >12 months from completion of therapy are permitted
Subjects will be considered cisplatin-ineligible, and will receive carboplatin, if they meet at least one of the following criteria:
Subjects with a GFR ≥50 mL/min and no other cisplatin ineligibility criteria may be considered cisplatin-eligible based on the investigator’s clinical judgment.
ii.ECOG or WHO performance status of 2
iii.NCI CTCAE Grade ≥2 audiometric hearing loss
iv.NYHA Class III heart failure
For More Detailed Information, Contact:
ClinicalTrials.gov Identifier: NCT03682068