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NCT00616941 · ClinicalTrials.gov registry record · Phase 1
Phase 1 Study of NY-ESO-1 Overlapping Peptides in Epithelial Ovarian, Fallopian Tube, or Primary Peritoneal Cancer
A Phase 1 study, sponsored by Ludwig Institute for Cancer Research.
- Completed
- Registry status
- Phase 1
- Development phase
- 28
- Enrollment target
NCT00616941: Completed Phase 1 study, sponsored by Ludwig Institute for Cancer Research.
NCT00616941 is a Phase 1 study that has completed, run by Ludwig Institute for Cancer Research. The registered enrollment target is 28 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (53% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00616941, a Phase 1 study, has completed, sponsored by Ludwig Institute for Cancer Research.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 28 participants
- Enrollment target
Study Summary
This was a Phase 1, open-label study of repeated vaccination with NY-ESO-1 overlapping peptides (OLP4) with or without the immunoadjuvants Montanide and polyinosinic-polycytidylic acid - poly-L-lysine carboxymethylcellulose (poly-ICLC) administered every 3 weeks for a total of 5 vaccinations in subjects with epithelial ovarian, fallopian tube, or primary peritoneal cancer in second or third clinical remission. Study objectives included determination of the safety and immunogenicity following vaccination.
Primary Outcome
Analysis of TEAEs reported from clinical laboratory tests, physical examinations, and vital signs from pre-treatment through 3 weeks after the last dose of study treatment.
Interventions
- BIOLOGICAL NY-ESO-1 OLP4
- BIOLOGICAL NY-ESO-1 OLP4 + Montanide
- BIOLOGICAL NY-ESO-1 OLP4 + Montanide + Poly-ICLC
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 28 participants |
| Start Date | 2008-03 |
| Est. Completion | 2011-06 |
| Phase | Phase 1 |
What the finished NCT00616941 record still lists
NCT00616941 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 28 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (53% lower).
The record links to 0 conditions, and to 3 interventions - of which NY-ESO-1 OLP4 is the first listed.
NCT00616941 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00616941 about?
NCT00616941 is a clinical study titled "Phase 1 Study of NY-ESO-1 Overlapping Peptides in Epithelial Ovarian, Fallopian Tube, or Primary Peritoneal Cancer". This was a Phase 1, open-label study of repeated vaccination with NY-ESO-1 overlapping peptides (OLP4) with or without the immunoadjuvants Montanide and polyinosinic-polycytidylic acid - poly-L-lysine carboxymethylcellulose (poly-ICLC) administered every 3 weeks for a total of 5 vaccinations in subj...
What is the current status of trial NCT00616941?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 28 participants. The study started on 2008-03. Estimated completion is 2011-06.
What interventions are being tested in trial NCT00616941?
The interventions under investigation include: NY-ESO-1 OLP4 (BIOLOGICAL), NY-ESO-1 OLP4 + Montanide (BIOLOGICAL), NY-ESO-1 OLP4 + Montanide + Poly-ICLC (BIOLOGICAL).
Who is sponsoring clinical trial NCT00616941?
This trial is sponsored by Ludwig Institute for Cancer Research, which has 30 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00616941's enrollment target sits among peer trials
28 1447th of 2000 higher than 538 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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