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NCT03547973 · ClinicalTrials.gov registry record · Phase 2
Study of Sacituzumab Govitecan in Participants With Urothelial Cancer That Cannot Be Removed or Has Spread
A Phase 2 study of Metastatic Urothelial Cancer, sponsored by Gilead Sciences.
- Recruiting
- Registry status
- Phase 2
- Development phase
- 827
- Enrollment target
- 20
- Study locations
NCT03547973: Recruiting Phase 2 study of Metastatic Urothelial Cancer, sponsored by Gilead Sciences.
NCT03547973 is a Phase 2 study of Metastatic Urothelial Cancer that is actively recruiting participants, run by Gilead Sciences. The registered enrollment target is 827 participants, above the 487-participant average among 5 other Metastatic Urothelial Cancer trials with a reported enrollment target (70% higher). The trial reports 20 study locations across 13 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03547973, a Phase 2 study of Metastatic Urothelial Cancer, is actively recruiting participants, sponsored by Gilead Sciences.
- RECRUITING
- Registry status
- Phase 2
- Development phase
- 827 participants
- Enrollment target
- 20
- Study locations
Study Summary
The objective of this study is to evaluate the efficacy and safety of sacituzumab govitecan-hziy monotherapy and with novel combinations in participants with metastatic urothelial cancer (mUC).
Primary Outcome
ORR will be defined as the rate of the best overall response as Complete Response (CR) or Partial Response (PR) and based on central review by Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) criteria.
Conditions Studied
Interventions
- DRUG Pembrolizumab
- DRUG Cisplatin
- DRUG Zimberelimab
- DRUG Avelumab
- DRUG Sacituzumab Govitecan-hziy
Study Locations (20)
Florida
- Mount Sinai Comprehensive Cancer Center - Miami Beach
- Woodlands Medical Specialists, PA - Pensacola
- Moffitt Cancer Center - Tampa
Illinois
- University of Illinois Cancer Center - Chicago
- University of Chicago Medical Center - Chicago
- Southern Illinois University School of Medicine, Simmons Cancer Institute - Springfield
California
- USC/Norris Comprehensive Cancer Center - Los Angeles
- University of California San Francisco - San Francisco
Connecticut
- Smilow Cancer Hospital at Yale-New Haven - New Haven
- Eastern Connecticut Hematology and Oncology Associates - Norwich
Michigan
- University of Michigan - Ann Arbor
- Karmanos Cancer Institute - Detroit
Arizona
- The University of Arizona Cancer Center-North Campus - Tucson
Colorado
- Rocky Mountain Cancer Centers - Littleton
Georgia
- Winship Cancer Institute, Emory University - Atlanta
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 827 participants |
| Start Date | 2018-08-13 |
| Est. Completion | 2030-04 |
| Phase | Phase 2 |
What NCT03547973 shows while recruiting
NCT03547973 is an interventional study that assigns participants to a tested intervention. The registered 827 participants enrollment target is mid-sized for trials with a published cap, above the 487-participant average among 5 other Metastatic Urothelial Cancer trials with a reported enrollment target (70% higher).
The record links to 1 condition, with Metastatic Urothelial Cancer appearing as the primary indexed condition, and to 5 interventions - of which Pembrolizumab is the first listed.
NCT03547973 names 20 study sites across 13 states, led by Florida, Illinois, California.
Frequently Asked Questions
What is clinical trial NCT03547973 about?
NCT03547973 is a clinical study titled "Study of Sacituzumab Govitecan in Participants With Urothelial Cancer That Cannot Be Removed or Has Spread". The objective of this study is to evaluate the efficacy and safety of sacituzumab govitecan-hziy monotherapy and with novel combinations in participants with metastatic urothelial cancer (mUC).
What is the current status of trial NCT03547973?
This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 827 participants. The study started on 2018-08-13. Estimated completion is 2030-04.
What conditions does trial NCT03547973 study?
This clinical trial studies the following conditions: Metastatic Urothelial Cancer.
What interventions are being tested in trial NCT03547973?
The interventions under investigation include: Pembrolizumab (DRUG), Cisplatin (DRUG), Zimberelimab (DRUG), Avelumab (DRUG), Sacituzumab Govitecan-hziy (DRUG).
Who is sponsoring clinical trial NCT03547973?
This trial is sponsored by Gilead Sciences, which has 504 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03547973 being conducted?
This trial has 20 study locations across Arizona, California, Colorado, Connecticut, Florida. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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