Study of Durvalumab Given With Chemotherapy, Durvalumab in Combination With Tremelimumab Given With Chemotherapy, or Chemotherapy in Patients With Unresectable Urothelial Cancer
Public ClinicalTrials.gov record NCT03682068. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official 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.
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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).
Study identification
- NCT ID
- NCT03682068
- Recruitment status
- Active, not recruiting
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 1,246 participants
Conditions and interventions
Interventions
- Durvalumab Drug
- Tremelimumab Drug
- Cisplatin + Gemcitabine Drug
- Carboplatin + Gemcitabine Drug
Drug
Eligibility (public fields only)
- Age range
- 18 Years to 130 Years
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Sep 27, 2018 (Actual)
- Primary completion
- Jun 1, 2026 (Actual)
- Completion
- Jun 1, 2027 (Estimated)
- Last update posted
- Aug 20, 2026
2018 – 2027
United States locations
- U.S. sites
- 23
- U.S. states
- 15
- U.S. cities
- 22
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Research Site | Birmingham | Alabama | 35294 | — |
| Research Site | Bakersfield | California | 93309 | — |
| Research Site | Fullerton | California | 92835 | — |
| Research Site | Los Angeles | California | 90024 | — |
| Research Site | Salinas | California | 93901 | — |
| Research Site | Santa Barbara | California | 93105 | — |
| Research Site | Truckee | California | 96161 | — |
| Research Site | New Haven | Connecticut | 06520 | — |
| Research Site | Washington D.C. | District of Columbia | 20007 | — |
| Research Site | Orlando | Florida | 32806 | — |
| Research Site | Chicago | Illinois | 60611 | — |
| Research Site | Fort Wayne | Indiana | 46804 | — |
| Research Site | Kansas City | Kansas | 66160 | — |
| Research Site | Louisville | Kentucky | 40202 | — |
| Research Site | New Orleans | Louisiana | 70112 | — |
| Research Site | Grand Rapids | Michigan | 49503 | — |
| Research Site | Bozeman | Montana | 59715 | — |
| Research Site | New Hyde Park | New York | 11042 | — |
| Research Site | New York | New York | 10029 | — |
| Research Site | New York | New York | 10065 | — |
| Research Site | Rochester | New York | 14642 | — |
| Research Site | Germantown | Tennessee | 38138 | — |
| Research Site | Fort Worth | Texas | 76104 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 199 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT03682068, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Aug 20, 2026 · Synced Oct 20, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT03682068 live on ClinicalTrials.gov.