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NCT03682068 · ClinicalTrials.gov registry record · Phase 3
Study of Durvalumab Given With Chemotherapy, Durvalumab in Combination With Tremelimumab Given With Chemotherapy, or Chemotherapy in Patients With Unresectable Urothelial Cancer
A Phase 3 study of Metastatic Urothelial Cancer and Unresectable Locally Advanced Urothelial Cancer, sponsored by AstraZeneca.
- Active
- Registry status
- Phase 3
- Development phase
- 1,246
- Enrollment target
- 20
- Study locations
NCT03682068: Active Phase 3 study of Metastatic Urothelial Cancer and Unresectable Locally Advanced Urothelial Cancer, sponsored by AstraZeneca.
NCT03682068 is a Phase 3 study of Metastatic Urothelial Cancer and Unresectable Locally Advanced Urothelial Cancer that is active but no longer recruiting, run by AstraZeneca. The registered enrollment target is 1,246 participants, above the 403-participant average among 5 other Metastatic Urothelial Cancer trials with a reported enrollment target (209% higher). The trial reports 20 study locations across 13 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03682068, a Phase 3 study of Metastatic Urothelial Cancer and Unresectable Locally Advanced Urothelial Cancer, is active but no longer recruiting, sponsored by AstraZeneca.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 3
- Development phase
- 1,246 participants
- Enrollment target
- 20
- Study locations
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).
Primary Outcome
OS is defined as the time from the date of randomization until death due to any cause
Conditions Studied
Interventions
- DRUG Durvalumab
- DRUG Tremelimumab
- DRUG Cisplatin + Gemcitabine
- DRUG Carboplatin + Gemcitabine
Study Locations (20)
California
- Research Site - Bakersfield
- Research Site - Fullerton
- Research Site - Los Angeles
- Research Site - Salinas
- Research Site - Santa Barbara
- Research Site - Truckee
New York
- Research Site - New Hyde Park
- Research Site - New York
- Research Site - New York
Alabama
- Research Site - Birmingham
Connecticut
- Research Site - New Haven
District of Columbia
- Research Site - Washington D.C.
Florida
- Research Site - Orlando
Illinois
- Research Site - Chicago
Indiana
- Research Site - Fort Wayne
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 1,246 participants |
| Start Date | 2018-09-27 |
| Est. Completion | 2026-04-29 |
| Phase | Phase 3 |
What the registry record for NCT03682068 still lists
NCT03682068 is an interventional study that assigns participants to a tested intervention. Its 1,246 participants enrollment target places it among the larger protocols in the corpus, above the 403-participant average among 5 other Metastatic Urothelial Cancer trials with a reported enrollment target (209% higher).
The record links to 2 conditions, with Metastatic Urothelial Cancer appearing as the primary indexed condition, and to 4 interventions - of which Durvalumab is the first listed.
NCT03682068 names 20 study sites across 13 states, led by California, New York, Alabama.
Frequently Asked Questions
What is clinical trial NCT03682068 about?
NCT03682068 is a clinical study titled "Study of Durvalumab Given With Chemotherapy, Durvalumab in Combination With Tremelimumab Given With Chemotherapy, or Chemotherapy in Patients With Unresectable Urothelial Cancer". 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 ve...
What is the current status of trial NCT03682068?
This trial is currently active not recruiting. It is a Phase 3 study. The enrollment target is 1,246 participants. The study started on 2018-09-27. Estimated completion is 2026-04-29.
What conditions does trial NCT03682068 study?
This clinical trial studies the following conditions: Metastatic Urothelial Cancer, Unresectable Locally Advanced Urothelial Cancer.
What interventions are being tested in trial NCT03682068?
The interventions under investigation include: Durvalumab (DRUG), Tremelimumab (DRUG), Cisplatin + Gemcitabine (DRUG), Carboplatin + Gemcitabine (DRUG).
Who is sponsoring clinical trial NCT03682068?
This trial is sponsored by AstraZeneca, which has 1,285 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03682068 being conducted?
This trial has 20 study locations across Alabama, California, Connecticut, District of Columbia, Florida. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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