Study of Durvalumab Given With Chemotherapy, Durvalumab in Combination With Tremelimumab Given With Chemotherapy, or Chemotherapy in Patients With Unresectable Urothelial Cancer
Running, not enrolling · Phase 3
Conditions studied: Unresectable Locally Advanced Urothelial Cancer, Metastatic Urothelial Cancer
In brief
This is a randomized, open-label, controlled, multi-center, global Phase III study to determine the efficacy and safety of combining durvalumab ± tremelimumab with standard of care (SoC) chemotherapy (cisplatin + gemcitabine or carboplatin + gemcitabine doublet) followed by durvalumab monotherapy versus SoC alone as first-line chemotherapy in patients with histologically or cytologically documented, unresectable, locally advanced or metastatic transitional cell carcinoma of the urothelium (including renal pelvis, ureters, urinary bladder, and urethra).
Key facts
- Study ID
- NCT03682068
- Run by
- AstraZeneca
- People needed
- 1246
- Starts
- 2018-09-27
- Expected to finish
- 2027-06-01
- Last updated by the study team
- 2026-05-28
Who can join
Age: 18 and older, up to 130. Sex: any. Healthy volunteers: not accepted.
Where it is running
- Research Site — Bakersfield, California, United States
- Research Site — Fullerton, California, United States
- Research Site — Los Angeles, California, United States
- Research Site — Salinas, California, United States
- Research Site — Santa Barbara, California, United States
- Research Site — Truckee, California, United States
- Research Site — New Haven, Connecticut, United States
- Research Site — Washington D.C., District of Columbia, United States
- Research Site — Orlando, Florida, United States
- Research Site — Chicago, Illinois, United States
- Research Site — Fort Wayne, Indiana, United States
- Research Site — Kansas City, Kansas, United States
- Research Site — Louisville, Kentucky, United States
- Research Site — New Orleans, Louisiana, United States
- Research Site — Grand Rapids, Michigan, United States
- Research Site — Bozeman, Montana, United States
- Research Site — New Hyde Park, New York, United States
- Research Site — New York, New York, United States
- Research Site — New York, New York, United States
- Research Site — Rochester, New York, United States
- Research Site — Germantown, Tennessee, United States
- Research Site — Fort Worth, Texas, United States
- Research Site — Ciudad de Buenos Aires, Argentina
- Research Site — Ciudad de Buenos Aires, Argentina
- Research Site — Birmingham, Alabama, United States
Full record on ClinicalTrials.gov
Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.