Study of Durvalumab Given With Chemotherapy, Durvalumab in Combination With Tremelimumab Given With Chemotherapy, or Chemotherapy in Patients With Unresectable Urothelial Cancer
Condition(s) studied
Investigational drug(s) / intervention(s)
Durvalumab: Durvalumab IV (intravenous infusion)
Tremelimumab: Tremelimumab IV (intravenous infusion)
Cisplatin + Gemcitabine: Cisplatin IV (intravenous)+ Gemcitabine IV(intravenous), as standard of care.
Carboplatin + Gemcitabine: Carboplatin IV (intravenous)+ Gemcitabine IV(intravenous), as standard of care.
Study summary
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).
Eligibility
Primary outcome measure(s)
- Overall Survival (OS) — approximately 5 years
OS is defined as the time from the date of randomization until death due to any cause
Trial sites (222)
| Facility | City | Region | Status |
|---|---|---|---|
| Research Site | Birmingham | Alabama | |
| Research Site | Bakersfield | California | |
| Research Site | Fullerton | California | |
| Research Site | Los Angeles | California | |
| Research Site | Salinas | California | |
| Research Site | Santa Barbara | California | |
| Research Site | Truckee | California | |
| Research Site | New Haven | Connecticut | |
| Research Site | Washington D.C. | District of Columbia | |
| Research Site | Orlando | Florida | |
| Research Site | Chicago | Illinois | |
| Research Site | Fort Wayne | Indiana | |
| Research Site | Kansas City | Kansas | |
| Research Site | Louisville | Kentucky | |
| Research Site | New Orleans | Louisiana | |
| Research Site | Grand Rapids | Michigan | |
| Research Site | Bozeman | Montana | |
| Research Site | New Hyde Park | New York | |
| Research Site | New York | New York | |
| Research Site | New York | New York | |
| Research Site | Rochester | New York | |
| Research Site | Germantown | Tennessee | |
| Research Site | Fort Worth | Texas | |
| Research Site | Ciudad de Buenos Aires | Argentina | |
| Research Site | Ciudad de Buenos Aires | Argentina | |
| Research Site | Ciudad de Buenos Aires | Argentina | |
| Research Site | Ciudad de Buenos Aires | Argentina | |
| Research Site | Rosario | Argentina | |
| Research Site | Box Hill | Australia | |
| Research Site | Elizabeth Vale | Australia | |
| Research Site | Kogarah | Australia | |
| Research Site | Macquarie University | Australia | |
| Research Site | Murdoch | Australia | |
| Research Site | Orange | Australia | |
| Research Site | South Brisbane | Australia | |
| Research Site | St Albans | Australia | |
| Research Site | Curitiba | Brazil | |
| Research Site | Fortaleza | Brazil | |
| Research Site | Porto Alegre | Brazil | |
| Research Site | Porto Alegre | Brazil |
+ 182 more sites — see the full list on the official registry below.
On this site
📄 Imfinzi (durvalumab) drug profile →More AstraZeneca trials in South Korea
Other trials for the same condition
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT03682068 on ClinicalTrials.gov ↗ ← All trials in South Korea