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NCT02636582 · ClinicalTrials.gov registry record · Phase 2
Nelipepimut-S Plus GM-CSF Vaccine Therapy in Treating Patients With Breast Cancer
A Phase 2 study, sponsored by National Cancer Institute (NCI).
- Completed
- Registry status
- Phase 2
- Development phase
- 43
- Enrollment target
NCT02636582: Completed Phase 2 study, sponsored by National Cancer Institute (NCI).
NCT02636582 is a Phase 2 study that has completed, run by National Cancer Institute (NCI). The registered enrollment target is 43 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (68% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02636582, a Phase 2 study, has completed, sponsored by National Cancer Institute (NCI).
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 43 participants
- Enrollment target
Study Summary
This phase II trial studies how well nelipepimut-S plus GM-CSF vaccine therapy or sargramostim works in treating patients with breast cancer. Vaccines made from peptide or antigen and/or a person's white blood cells mixed with tumor proteins may help the body build an effective immune response to kill tumor cells that express breast cancer antigens. It is not yet known whether nelipepimut-S plus GM-CSF vaccine or sargramostim is more effective in treating patients with breast cancer.
Primary Outcome
Change from baseline in the Mean percent of Nelipepimut-S-specific cytotoxic T lymphocyte response one-month post-surgical resection. Wilcoxon rank sum test exact P-value was used.
Interventions
- OTHER Laboratory Biomarker Analysis
- PROCEDURE Surgical Procedure
- BIOLOGICAL Sargramostim
- DRUG Nelipepimut-S Plus GM-CSF Vaccine
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 43 participants |
| Start Date | 2016-06-14 |
| Est. Completion | 2023-05-17 |
| Phase | Phase 2 |
What the finished NCT02636582 record still lists
NCT02636582 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 43 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (68% lower).
The record links to 0 conditions, and to 4 interventions - of which Laboratory Biomarker Analysis is the first listed.
NCT02636582 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02636582 about?
NCT02636582 is a clinical study titled "Nelipepimut-S Plus GM-CSF Vaccine Therapy in Treating Patients With Breast Cancer". This phase II trial studies how well nelipepimut-S plus GM-CSF vaccine therapy or sargramostim works in treating patients with breast cancer. Vaccines made from peptide or antigen and/or a person's white blood cells mixed with tumor proteins may help the body build an effective immune response to ki...
What is the current status of trial NCT02636582?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 43 participants. The study started on 2016-06-14. Estimated completion is 2023-05-17.
What interventions are being tested in trial NCT02636582?
The interventions under investigation include: Laboratory Biomarker Analysis (OTHER), Surgical Procedure (PROCEDURE), Sargramostim (BIOLOGICAL), Nelipepimut-S Plus GM-CSF Vaccine (DRUG).
Who is sponsoring clinical trial NCT02636582?
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 NCT02636582's enrollment target sits among peer trials
43 1332nd of 2000 higher than 662 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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