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NCT03557918 · ClinicalTrials.gov registry record · Phase 2
Trial of Tremelimumab in Patients With Previously Treated Metastatic Urothelial Cancer
A Phase 2 study, sponsored by Matthew Galsky.
- Completed
- Registry status
- Phase 2
- Development phase
- 26
- Enrollment target
NCT03557918: Completed Phase 2 study, sponsored by Matthew Galsky.
NCT03557918 is a Phase 2 study that has completed, run by Matthew Galsky. The registered enrollment target is 26 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (80% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03557918, a Phase 2 study, has completed, sponsored by Matthew Galsky.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 26 participants
- Enrollment target
Study Summary
This is a phase II trial designed to estimate the activity of single agent tremelimumab in subjects with metastatic urothelial cancer with disease progression despite prior treatment with PD-1/PD-L1 blockade. The primary endpoint is objective response rate and the study will employ a Simon's 2-stage design.
Primary Outcome
Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST): Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Progressive Disease (PD) \>= 20% increase in tumor burden relative to nadir or the appearance of one or more new lesions; Stable Disease (SD), not meet criteria for CR/PR/PD. ORR is defined as the proportion of all subjects with confirmed PR or CR according to RECIST 1.1.
Interventions
- DRUG Tremelimumab
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 26 participants |
| Start Date | 2018-11-12 |
| Est. Completion | 2023-06-07 |
| Phase | Phase 2 |
What the finished NCT03557918 record still lists
NCT03557918 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 26 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (80% lower).
The record links to 0 conditions, and to 1 intervention - of which Tremelimumab is the first listed.
NCT03557918 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03557918 about?
NCT03557918 is a clinical study titled "Trial of Tremelimumab in Patients With Previously Treated Metastatic Urothelial Cancer". This is a phase II trial designed to estimate the activity of single agent tremelimumab in subjects with metastatic urothelial cancer with disease progression despite prior treatment with PD-1/PD-L1 blockade. The primary endpoint is objective response rate and the study will employ a Simon's 2-stage...
What is the current status of trial NCT03557918?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 26 participants. The study started on 2018-11-12. Estimated completion is 2023-06-07.
What interventions are being tested in trial NCT03557918?
The interventions under investigation include: Tremelimumab (DRUG).
Who is sponsoring clinical trial NCT03557918?
This trial is sponsored by Matthew Galsky, which has 12 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03557918's enrollment target sits among peer trials
26 1708th of 2000 higher than 282 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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