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NCT02019524 · ClinicalTrials.gov registry record · Phase 1
Phase Ib Trial of Two Folate Binding Protein Peptide Vaccines (E39 and J65) in Breast and Ovarian Cancer Patients
A Phase 1 study, sponsored by COL George Peoples, MD, FACS.
- Completed
- Registry status
- Phase 1
- Development phase
- 39
- Enrollment target
NCT02019524: Completed Phase 1 study, sponsored by COL George Peoples, MD, FACS.
NCT02019524 is a Phase 1 study that has completed, run by COL George Peoples, MD, FACS. The registered enrollment target is 39 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (35% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02019524, a Phase 1 study, has completed, sponsored by COL George Peoples, MD, FACS.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 39 participants
- Enrollment target
Study Summary
This is a single-center, randomized, single-blinded, three-arm phase Ib study of the folate binding protein vaccines E39 and J65. The study target population are patients with breast or ovarian cancer diagnosis who have been treated and are without evidence of disease. Disease-free subjects after standard of care multi-modality therapy will be screened and HLA typed. E39 and J65 are cytotoxic T-lymphocyte-eliciting peptide vaccines that are restricted to HLA-A2+ patients (approximately 50% of the U.S. population).
Primary Outcome
Determine which of the following primary vaccination strategy maximizes long-term specific immunity defined as E39-specific cytotoxic T lymphocytes (CTLs) six months following completion of the primary vaccination series.
Interventions
- BIOLOGICAL E39 peptide vaccine
- BIOLOGICAL E39 vaccine then J65 vaccine
- BIOLOGICAL J65 vaccine then E39 vaccine
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 39 participants |
| Start Date | 2013-09-30 |
| Est. Completion | 2016-12-06 |
| Phase | Phase 1 |
What the finished NCT02019524 record still lists
NCT02019524 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 39 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (35% lower).
The record links to 0 conditions, and to 3 interventions - of which E39 peptide vaccine is the first listed.
NCT02019524 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02019524 about?
NCT02019524 is a clinical study titled "Phase Ib Trial of Two Folate Binding Protein Peptide Vaccines (E39 and J65) in Breast and Ovarian Cancer Patients". This is a single-center, randomized, single-blinded, three-arm phase Ib study of the folate binding protein vaccines E39 and J65. The study target population are patients with breast or ovarian cancer diagnosis who have been treated and are without evidence of disease. Disease-free subjects after st...
What is the current status of trial NCT02019524?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 39 participants. The study started on 2013-09-30. Estimated completion is 2016-12-06.
What interventions are being tested in trial NCT02019524?
The interventions under investigation include: E39 peptide vaccine (BIOLOGICAL), E39 vaccine then J65 vaccine (BIOLOGICAL), J65 vaccine then E39 vaccine (BIOLOGICAL).
Who is sponsoring clinical trial NCT02019524?
This trial is sponsored by COL George Peoples, MD, FACS, which has 4 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02019524's enrollment target sits among peer trials
39 1191st of 2000 higher than 804 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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