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NCT01989572 · ClinicalTrials.gov registry record · Phase 3
Sargramostim, Vaccine Therapy, or Sargramostim and Vaccine Therapy in Preventing Disease Recurrence in Patients With Melanoma That Has Been Removed By Surgery
A Phase 3 study, sponsored by National Cancer Institute (NCI).
- Completed
- Registry status
- Phase 3
- Development phase
- 815
- Enrollment target
NCT01989572: Completed Phase 3 study, sponsored by National Cancer Institute (NCI).
NCT01989572 is a Phase 3 study that has completed, run by National Cancer Institute (NCI). The registered enrollment target is 815 participants, roughly in line with the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01989572, a Phase 3 study, has completed, sponsored by National Cancer Institute (NCI).
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 815 participants
- Enrollment target
Study Summary
This randomized phase III trial studies sargramostim or vaccine therapy alone to see how well they work compared to sargramostim and vaccine therapy together in preventing disease recurrence in patients with melanoma that has been removed by surgery. Sargramostim may stimulate the immune system in different ways and stop tumor cells from growing. Vaccines made from peptides may help the body build an effective immune response to kill tumor cells. It is not yet known whether yeast derived sargramostim and vaccine therapy are more effective alone or together in preventing recurrence of melanoma.
Primary Outcome
Overall survival is defined as time from randomization to death from any cause.
Interventions
- OTHER Placebo
- OTHER Laboratory Biomarker Analysis
- BIOLOGICAL Sargramostim
- BIOLOGICAL Tyrosinase Peptide
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 815 participants |
| Start Date | 2000-02-23 |
| Est. Completion | 2013-01-31 |
| Phase | Phase 3 |
What the finished NCT01989572 record still lists
NCT01989572 is an interventional study that assigns participants to a tested intervention. The registered 815 participants enrollment target is mid-sized for trials with a published cap, roughly in line with the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target.
The record links to 0 conditions, and to 4 interventions - of which Placebo is the first listed.
NCT01989572 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01989572 about?
NCT01989572 is a clinical study titled "Sargramostim, Vaccine Therapy, or Sargramostim and Vaccine Therapy in Preventing Disease Recurrence in Patients With Melanoma That Has Been Removed By Surgery". This randomized phase III trial studies sargramostim or vaccine therapy alone to see how well they work compared to sargramostim and vaccine therapy together in preventing disease recurrence in patients with melanoma that has been removed by surgery. Sargramostim may stimulate the immune system in d...
What is the current status of trial NCT01989572?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 815 participants. The study started on 2000-02-23. Estimated completion is 2013-01-31.
What interventions are being tested in trial NCT01989572?
The interventions under investigation include: Placebo (OTHER), Laboratory Biomarker Analysis (OTHER), Sargramostim (BIOLOGICAL), Tyrosinase Peptide (BIOLOGICAL).
Who is sponsoring clinical trial NCT01989572?
This trial is sponsored by National Cancer Institute (NCI), which has 3,257 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01989572's enrollment target sits among peer trials
815 406th of 2000 higher than 1,594 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 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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