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NCT03534804 · ClinicalTrials.gov registry record · Phase 2
Cabozantinib Plus Pembrolizumab as First-Line Therapy for Cisplatin-Ineligible Advanced Urothelial Carcinoma
A Phase 2 study, sponsored by University of Utah.
- Completed
- Registry status
- Phase 2
- Development phase
- 37
- Enrollment target
NCT03534804: Completed Phase 2 study, sponsored by University of Utah.
NCT03534804 is a Phase 2 study that has completed, run by University of Utah. The registered enrollment target is 37 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (72% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03534804, a Phase 2 study, has completed, sponsored by University of Utah.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 37 participants
- Enrollment target
Study Summary
This is an open label, non-randomized phase 2 study of the combination of pembrolizumab and cabozantinib to assess overall response rate (ORR), progression free survival at 6 months (PFS6), and overall survival (OS) in patients with metastatic urothelial carcinoma (UC) ineligible for cisplatin.
Primary Outcome
To evaluate measurable disease overall response. Subjects were evaluated by CT scans at regular intervals for disease assessment by RECISTv1.1 criteria for the duration of treatment. Response Evaluation Criteria in Solid Tumors (RECIST) is a standard measure of how well cancer patients respond to treatment. Possible scores are CR (Complete Response; total disappearance of all target lesions), PR (Partial Response; at least a 30% decrease of the sum of the longest diameter of all target lesions)
Interventions
- DRUG Pembrolizumab
- DRUG Cabozantinib
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 37 participants |
| Start Date | 2018-09-18 |
| Est. Completion | 2024-04-15 |
| Phase | Phase 2 |
What the finished NCT03534804 record still lists
NCT03534804 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 37 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (72% lower).
The record links to 0 conditions, and to 2 interventions - of which Pembrolizumab is the first listed.
NCT03534804 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03534804 about?
NCT03534804 is a clinical study titled "Cabozantinib Plus Pembrolizumab as First-Line Therapy for Cisplatin-Ineligible Advanced Urothelial Carcinoma". This is an open label, non-randomized phase 2 study of the combination of pembrolizumab and cabozantinib to assess overall response rate (ORR), progression free survival at 6 months (PFS6), and overall survival (OS) in patients with metastatic urothelial carcinoma (UC) ineligible for cisplatin.
What is the current status of trial NCT03534804?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 37 participants. The study started on 2018-09-18. Estimated completion is 2024-04-15.
What interventions are being tested in trial NCT03534804?
The interventions under investigation include: Pembrolizumab (DRUG), Cabozantinib (DRUG).
Who is sponsoring clinical trial NCT03534804?
This trial is sponsored by University of Utah, which has 818 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03534804's enrollment target sits among peer trials
37 1484th of 2000 higher than 505 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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