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NCT03325101 · ClinicalTrials.gov registry record · Phase 1
Dendritic Cell Therapy With Pembrolizumab for Metastatic or Unresectable Melanoma
A Phase 1 study, sponsored by Mayo Clinic.
- Terminated
- Registry status
- Phase 1
- Development phase
- 7
- Enrollment target
NCT03325101: Clinical Trial Phase 1 study, sponsored by Mayo Clinic.
NCT03325101 is a Phase 1 study that was terminated before completion, run by Mayo Clinic. The registered enrollment target is 7 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (88% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03325101, a Phase 1 study, was terminated before completion, sponsored by Mayo Clinic.
- TERMINATED
- Registry status
- Phase 1
- Development phase
- 7 participants
- Enrollment target
Study Summary
This phase Ib/II trial studies how well dendritic cell therapy after cryosurgery in combination with pembrolizumab works in treating patients with stage III-IV melanoma that cannot be removed by surgery. Vaccines made from a person's white blood cells mixed with tumor proteins may help the body build an effective immune response to kill tumor cells. Cryosurgery, also known as cryoablation or cryotherapy, kills tumor cells by freezing them. Monoclonal antibodies, such as pembrolizumab, may block tumor growth in different ways by targeting certain cells. Giving dendritic cell therapy after cryosurgery in combination with pembrolizumab may work better in treating patients with melanoma.
Primary Outcome
The primary outcome of the Phase I portion of this trial was to establish the tolerability of the proposed treatment schedule in order to move it forward into the Phase II portion of the trial. A maximum of 6 patients was to be enrolled onto the Schedule 1. If at most one of these 6 patients developed a DLT during the first 3 treatment cycles, then Schedule #1 would be carried forward to the Phase II portion of the trial. If not, then an additional 6 patients would be treated with a modified Sch
Interventions
- BIOLOGICAL Pembrolizumab
- PROCEDURE Cryosurgery
- PROCEDURE Pheresis
- BIOLOGICAL Therapeutic Autologous Dendritic Cells
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 7 participants |
| Start Date | 2017-11-15 |
| Est. Completion | 2020-06-14 |
| Phase | Phase 1 |
Why NCT03325101 stopped before completion
NCT03325101 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 7 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (88% lower).
The record links to 0 conditions, and to 4 interventions - of which Pembrolizumab is the first listed.
NCT03325101 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03325101 about?
NCT03325101 is a clinical study titled "Dendritic Cell Therapy With Pembrolizumab for Metastatic or Unresectable Melanoma". This phase Ib/II trial studies how well dendritic cell therapy after cryosurgery in combination with pembrolizumab works in treating patients with stage III-IV melanoma that cannot be removed by surgery. Vaccines made from a person's white blood cells mixed with tumor proteins may help the body buil...
What is the current status of trial NCT03325101?
This trial is currently terminated. It is a Phase 1 study. The enrollment target is 7 participants. The study started on 2017-11-15. Estimated completion is 2020-06-14.
What interventions are being tested in trial NCT03325101?
The interventions under investigation include: Pembrolizumab (BIOLOGICAL), Cryosurgery (PROCEDURE), Pheresis (PROCEDURE), Therapeutic Autologous Dendritic Cells (BIOLOGICAL).
Who is sponsoring clinical trial NCT03325101?
This trial is sponsored by Mayo Clinic, which has 2,844 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03325101's enrollment target sits among peer trials
7 1972nd of 2000 higher than 27 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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