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NCT03149822 · ClinicalTrials.gov registry record · Phase 1
Study of Pembrolizumab and Cabozantinib in Patients With Metastatic Renal Cell Carcinoma
A Phase 1 study, sponsored by University of Colorado, Denver.
- Completed
- Registry status
- Phase 1
- Development phase
- 45
- Enrollment target
NCT03149822: Completed Phase 1 study, sponsored by University of Colorado, Denver.
NCT03149822 is a Phase 1 study that has completed, run by University of Colorado, Denver. The registered enrollment target is 45 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (25% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03149822, a Phase 1 study, has completed, sponsored by University of Colorado, Denver.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 45 participants
- Enrollment target
Study Summary
This is a phase I/II open-label study designed to evaluate the combination of pembrolizumab and cabozantinib in subjects with locally advanced, recurrent, or metastatic renal cell carcinoma. Sequential dose escalation of cabozantinib with standard dose pembrolizumab will occur in the phase I dose escalation part of the study to determine the recommended phase 2 dose (RP2D). Subsequently, subjects will receive cabozantinib at the RP2D in combination with pembrolizumab in the phase II dose expansion part of the study.
Primary Outcome
Measured through the complete response (CR) + partial response (PR)\] of pembrolizumab and cabozantinib when administered in combination in subjects with locally advanced or metastatic renal cell carcinoma. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR
Interventions
- DRUG Pembrolizumab
- DRUG Cabozantinib
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 45 participants |
| Start Date | 2017-09-28 |
| Est. Completion | 2024-02-16 |
| Phase | Phase 1 |
What the finished NCT03149822 record still lists
NCT03149822 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 45 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (25% lower).
The record links to 0 conditions, and to 2 interventions - of which Pembrolizumab is the first listed.
NCT03149822 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03149822 about?
NCT03149822 is a clinical study titled "Study of Pembrolizumab and Cabozantinib in Patients With Metastatic Renal Cell Carcinoma". This is a phase I/II open-label study designed to evaluate the combination of pembrolizumab and cabozantinib in subjects with locally advanced, recurrent, or metastatic renal cell carcinoma. Sequential dose escalation of cabozantinib with standard dose pembrolizumab will occur in the phase I dose es...
What is the current status of trial NCT03149822?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 45 participants. The study started on 2017-09-28. Estimated completion is 2024-02-16.
What interventions are being tested in trial NCT03149822?
The interventions under investigation include: Pembrolizumab (DRUG), Cabozantinib (DRUG).
Who is sponsoring clinical trial NCT03149822?
This trial is sponsored by University of Colorado, Denver, which has 1,283 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03149822's enrollment target sits among peer trials
45 1066th of 2000 higher than 915 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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