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NCT02510950 · ClinicalTrials.gov registry record · Phase 1
Neoepitope-based Personalized Vaccine Approach in Patients With Newly Diagnosed Glioblastoma
A Phase 1 study, sponsored by Washington University School of Medicine.
- Terminated
- Registry status
- Phase 1
- Development phase
- 1
- Enrollment target
NCT02510950: Clinical Trial Phase 1 study, sponsored by Washington University School of Medicine.
NCT02510950 is a Phase 1 study that was terminated before completion, run by Washington University School of Medicine. The registered enrollment target is 1 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (98% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02510950, a Phase 1 study, was terminated before completion, sponsored by Washington University School of Medicine.
- TERMINATED
- Registry status
- Phase 1
- Development phase
- 1 participants
- Enrollment target
Study Summary
The early clinical development paradigm for chemotherapeutic agents has significantly influenced the development of therapeutic cancer vaccines. However, there are major differences between these two classes of therapeutics that have important implications for early clinical development. Specifically, the phase 1 concept of dose escalation to find a maximum-tolerated dose does not apply to most therapeutic cancer vaccines. Most therapeutic cancer vaccines are associated with minimal toxicity at a range that is feasible to manufacture or administer, and there is little reason to believe that the maximum-tolerated dose is the most effective dose. In a recent article from the biostatistics literature, Simon et al. write that "the initial clinical trial of many new vaccines will not be a toxicity or dose-ranging trial but rather will involve administration of a fixed dose of vaccine … in most cases the dose selected will be based on preclinical findings or practical considerations. Using several dose levels in the initial study to find the minimal active dose or to characterize the dose-activity relationship is generally not realistic". Consistent with these recommendations, the general philosophy of the phase 1 clinical trial is to facilitate a prompt preliminary evaluation of the safety and immunogenicity of the personalized synthetic long peptide vaccine strategy. The proposed clinical trial will test a fixed dose of vaccine. There is considerable experience with the synthetic long peptide vaccine platform. The synthetic long peptide vaccine platform has an excellent safety profile, and the optimal dose appears to be based on practical considerations (solubility of the peptide). The dose to be tested in the proposed clinical trial is consistent with other similar cancer vaccine trials that have been recently completed or are currently ongoing. The sample size (n=10) will provide a reasonably reliable estimate of the safety and immunogenicity of the vaccine.
Interventions
- DRUG Temozolomide
- DRUG Poly-ICLC
- BIOLOGICAL Personalized peptide vaccine
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 1 participants |
| Start Date | 2015-12-03 |
| Est. Completion | 2017-02-14 |
| Phase | Phase 1 |
Why NCT02510950 stopped before completion
NCT02510950 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 1 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (98% lower).
The record links to 0 conditions, and to 3 interventions - of which Temozolomide is the first listed.
NCT02510950 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02510950 about?
NCT02510950 is a clinical study titled "Neoepitope-based Personalized Vaccine Approach in Patients With Newly Diagnosed Glioblastoma". The early clinical development paradigm for chemotherapeutic agents has significantly influenced the development of therapeutic cancer vaccines. However, there are major differences between these two classes of therapeutics that have important implications for early clinical development. Specificall...
What is the current status of trial NCT02510950?
This trial is currently terminated. It is a Phase 1 study. The enrollment target is 1 participants. The study started on 2015-12-03. Estimated completion is 2017-02-14.
What interventions are being tested in trial NCT02510950?
The interventions under investigation include: Temozolomide (DRUG), Poly-ICLC (DRUG), Personalized peptide vaccine (BIOLOGICAL).
Who is sponsoring clinical trial NCT02510950?
This trial is sponsored by Washington University School of Medicine, which has 1,502 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02510950's enrollment target sits among peer trials
1 2001st of 2000 the lowest 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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