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NCT00515528 · ClinicalTrials.gov registry record · Phase 2
Vaccination Plus Ontak in Patients With Metastatic Melanoma
A Phase 2 study, sponsored by University of Chicago.
- Terminated
- Registry status
- Phase 2
- Development phase
- 17
- Enrollment target
NCT00515528: Clinical Trial Phase 2 study, sponsored by University of Chicago.
NCT00515528 is a Phase 2 study that was terminated before completion, run by University of Chicago. The registered enrollment target is 17 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (87% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00515528, a Phase 2 study, was terminated before completion, sponsored by University of Chicago.
- TERMINATED
- Registry status
- Phase 2
- Development phase
- 17 participants
- Enrollment target
Study Summary
The purpose of this study is to determine if an experimental melanoma vaccine can produce an immune response in patients with metastatic melanoma, and if combining this vaccine with the drug Ontak can improve these immune responses. It is also hoped that this will lead to tumor shrinkage.
Primary Outcome
Proportion of Patients With a Best Response of Partial Response (PR), Stable Disease (SD), or Progressive Disease (PD). Response was evaluated every 6 weeks based on Response Evaluation In Solid Tumor (RECIST) version 1.1. Per RECIST v1.1 for target lesions and assessed by MRI and/or CT: Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Stable Disease (SD), neither sufficient shrinkage to qualify for a Partial Response nor sufficient increase to quali
Interventions
- DRUG Ontak
- BIOLOGICAL 4-peptide melanoma vaccine
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 17 participants |
| Start Date | 2007-04-23 |
| Est. Completion | 2016-03 |
| Phase | Phase 2 |
Why NCT00515528 stopped before completion
NCT00515528 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 17 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (87% lower).
The record links to 0 conditions, and to 2 interventions - of which Ontak is the first listed.
NCT00515528 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00515528 about?
NCT00515528 is a clinical study titled "Vaccination Plus Ontak in Patients With Metastatic Melanoma". The purpose of this study is to determine if an experimental melanoma vaccine can produce an immune response in patients with metastatic melanoma, and if combining this vaccine with the drug Ontak can improve these immune responses. It is also hoped that this will lead to tumor shrinkage.
What is the current status of trial NCT00515528?
This trial is currently terminated. It is a Phase 2 study. The enrollment target is 17 participants. The study started on 2007-04-23. Estimated completion is 2016-03.
What interventions are being tested in trial NCT00515528?
The interventions under investigation include: Ontak (DRUG), 4-peptide melanoma vaccine (BIOLOGICAL).
Who is sponsoring clinical trial NCT00515528?
This trial is sponsored by University of Chicago, which has 796 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00515528's enrollment target sits among peer trials
17 1903rd of 2000 higher than 93 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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