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NCT03200587 · ClinicalTrials.gov registry record · Phase 1
Cabometyx and Avelumab in Patients With Metastatic Renal Cell Carcinoma (mRCC)
A Phase 1 study, sponsored by University of Utah.
- Completed
- Registry status
- Phase 1
- Development phase
- 12
- Enrollment target
NCT03200587: Completed Phase 1 study, sponsored by University of Utah.
NCT03200587 is a Phase 1 study that has completed, run by University of Utah. The registered enrollment target is 12 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (80% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03200587, a Phase 1 study, has completed, sponsored by University of Utah.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 12 participants
- Enrollment target
Study Summary
This is an open-label, non-controlled, non-randomized, phase I dose-finding, of Cabometyx + Avelumab, to establish safety, feasibility, and the maximum tolerated dose (MTD) or Recommended Phase 2 Dose (RP2D) of Cabometyx in combination with Avelumab, and to investigate preliminary efficacy. The MTD or RP2D determined in this study will be used for a future study to formally test efficacy. The MTD determined by dose escalation will be the recommended Phase 2 dose.
Primary Outcome
To assess the safety and tolerability of Avelumab + Cabometyx in subjects with mRCC and determine the recommended Phase II dose (RP2D). Safety, tolerability, adverse events (AEs), serious adverse events (SAEs), dose-limiting toxicities (DLTs).
Interventions
- DRUG Cabozantinib
- DRUG Avelumab
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 12 participants |
| Start Date | 2018-06-21 |
| Est. Completion | 2021-11-25 |
| Phase | Phase 1 |
What the finished NCT03200587 record still lists
NCT03200587 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 12 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (80% lower).
The record links to 0 conditions, and to 2 interventions - of which Cabozantinib is the first listed.
NCT03200587 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03200587 about?
NCT03200587 is a clinical study titled "Cabometyx and Avelumab in Patients With Metastatic Renal Cell Carcinoma (mRCC)". This is an open-label, non-controlled, non-randomized, phase I dose-finding, of Cabometyx + Avelumab, to establish safety, feasibility, and the maximum tolerated dose (MTD) or Recommended Phase 2 Dose (RP2D) of Cabometyx in combination with Avelumab, and to investigate preliminary efficacy. The MTD ...
What is the current status of trial NCT03200587?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 12 participants. The study started on 2018-06-21. Estimated completion is 2021-11-25.
What interventions are being tested in trial NCT03200587?
The interventions under investigation include: Cabozantinib (DRUG), Avelumab (DRUG).
Who is sponsoring clinical trial NCT03200587?
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 NCT03200587's enrollment target sits among peer trials
12 1852nd of 2000 higher than 90 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 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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