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NCT03260504 · ClinicalTrials.gov registry record · Phase 1
Aldesleukin and Pembrolizumab in Treating Patients With Advanced or Metastatic Kidney Cancer
A Phase 1 study, sponsored by University of Washington.
- Terminated
- Registry status
- Phase 1
- Development phase
- 6
- Enrollment target
NCT03260504: Clinical Trial Phase 1 study, sponsored by University of Washington.
NCT03260504 is a Phase 1 study that was terminated before completion, run by University of Washington. The registered enrollment target is 6 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (90% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03260504, a Phase 1 study, was terminated before completion, sponsored by University of Washington.
- TERMINATED
- Registry status
- Phase 1
- Development phase
- 6 participants
- Enrollment target
Study Summary
This phase I trial studies the side effects and best dose of aldesleukin when given together with pembrolizumab in treating patients with kidney cancer that has spread to other parts of the body. Aldesleukin may stimulate white blood cells to kill kidney cancer cells. Immunotherapy with monoclonal antibodies, such as pembrolizumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to avoid recognition by immune cells. Giving aldesleukin and pembrolizumab may work better in treating patients with kidney cancer.
Primary Outcome
The safety analysis was based on subjects who experienced toxicities as defined by CTCAE v5.0 criteria. Safety was assessed by quantifying the toxicities and laboratory abnormalities by grades experienced, including any serious adverse events (SAEs). Only treatment-related adverse events with an incidence rate of at least 2.5% are reported.
Interventions
- BIOLOGICAL Pembrolizumab
- BIOLOGICAL Aldesleukin
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 6 participants |
| Start Date | 2018-08-28 |
| Est. Completion | 2022-07-26 |
| Phase | Phase 1 |
Why NCT03260504 stopped before completion
NCT03260504 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 6 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (90% lower).
The record links to 0 conditions, and to 2 interventions - of which Pembrolizumab is the first listed.
NCT03260504 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03260504 about?
NCT03260504 is a clinical study titled "Aldesleukin and Pembrolizumab in Treating Patients With Advanced or Metastatic Kidney Cancer". This phase I trial studies the side effects and best dose of aldesleukin when given together with pembrolizumab in treating patients with kidney cancer that has spread to other parts of the body. Aldesleukin may stimulate white blood cells to kill kidney cancer cells. Immunotherapy with monoclonal a...
What is the current status of trial NCT03260504?
This trial is currently terminated. It is a Phase 1 study. The enrollment target is 6 participants. The study started on 2018-08-28. Estimated completion is 2022-07-26.
What interventions are being tested in trial NCT03260504?
The interventions under investigation include: Pembrolizumab (BIOLOGICAL), Aldesleukin (BIOLOGICAL).
Who is sponsoring clinical trial NCT03260504?
This trial is sponsored by University of Washington, which has 1,048 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03260504's enrollment target sits among peer trials
6 1974th of 2000 higher than 12 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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