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NCT01970358 · ClinicalTrials.gov registry record · Phase 1
A Phase I Study With a Personalized NeoAntigen Cancer Vaccine in Melanoma
A Phase 1 study, sponsored by Patrick Ott, MD, PhD.
- Completed
- Registry status
- Phase 1
- Development phase
- 15
- Enrollment target
NCT01970358: Completed Phase 1 study, sponsored by Patrick Ott, MD, PhD.
NCT01970358 is a Phase 1 study that has completed, run by Patrick Ott, MD, PhD. The registered enrollment target is 15 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (75% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01970358, a Phase 1 study, has completed, sponsored by Patrick Ott, MD, PhD.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 15 participants
- Enrollment target
Study Summary
This research study is evaluating a new type of melanoma vaccine called "Personalized NeoAntigen Cancer Vaccine". The purpose of this study is to determine if it is possible to make and administer safely a vaccine against melanoma by using information gained from specific characteristics of the participant's own melanoma. It is known that melanomas have mutations (changes in genetic material) that are specific to an individual patient and tumor. These mutations can cause the tumor cells to produce proteins that appear very different from the body's own cells. It is possible that these proteins used in a vaccine may induce strong immune responses, which may help the participant's body fight any tumor cells that could cause the melanoma to come back in the future. The study will examine the safety of the vaccine when given at several different time points and will examine the participant's blood cells for signs that the vaccine induced an immune response.
Primary Outcome
Number of participants experiencing any of the following: * Grade-3 or -4 toxicity that is definitely, probably, or possibly related to the administration of vaccine * Grade-3 or -4 abnormal laboratory value that is definitely, probably, or possibly related to the administration of vaccine if it persists for more than 7 days, requires hospitalization, or medical intervention * Any grade-3 or grade- 4 toxicity that is considered, in the opinion of the investigator, to be dose-limiting * Any deat
Interventions
- BIOLOGICAL Poly-ICLC
- BIOLOGICAL Peptides
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 15 participants |
| Start Date | 2014-04 |
| Est. Completion | 2018-06 |
| Phase | Phase 1 |
What the finished NCT01970358 record still lists
NCT01970358 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 15 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (75% lower).
The record links to 0 conditions, and to 2 interventions - of which Poly-ICLC is the first listed.
NCT01970358 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01970358 about?
NCT01970358 is a clinical study titled "A Phase I Study With a Personalized NeoAntigen Cancer Vaccine in Melanoma". This research study is evaluating a new type of melanoma vaccine called "Personalized NeoAntigen Cancer Vaccine". The purpose of this study is to determine if it is possible to make and administer safely a vaccine against melanoma by using information gained from specific characteristics of the part...
What is the current status of trial NCT01970358?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 15 participants. The study started on 2014-04. Estimated completion is 2018-06.
What interventions are being tested in trial NCT01970358?
The interventions under investigation include: Poly-ICLC (BIOLOGICAL), Peptides (BIOLOGICAL).
Who is sponsoring clinical trial NCT01970358?
This trial is sponsored by Patrick Ott, MD, PhD, which has 2 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01970358's enrollment target sits among peer trials
15 1798th of 2000 higher than 157 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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