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NCT02721043 · ClinicalTrials.gov registry record · Phase 1
Safety and Immunogenicity of Personalized Genomic Vaccine to Treat Malignancies
A Phase 1 study, sponsored by Nina Bhardwaj.
- Completed
- Registry status
- Phase 1
- Development phase
- 13
- Enrollment target
NCT02721043: Completed Phase 1 study, sponsored by Nina Bhardwaj.
NCT02721043 is a Phase 1 study that has completed, run by Nina Bhardwaj. The registered enrollment target is 13 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (78% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02721043, a Phase 1 study, has completed, sponsored by Nina Bhardwaj.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 13 participants
- Enrollment target
Study Summary
The purpose of this study is to test the safety, tolerability, and immunogenicity of Personalized Genomic Vaccine 001 (PGV001) in subjects with advanced non-hematologic malignancies. PGV001 is a peptide vaccine that is based on a patient's own tumor sequence. Each patient's tumor is sequenced and peptides that correspond to the tumors are made. These peptides combined with the adjuvant Poly-ICLC (Hiltonol®, Oncovir) make PGV001. The adjuvant Poly-ICLC is added to boost the immune response to the peptides and together will expand immune cells to target cancer.
Primary Outcome
toxicity will be measured by severity of Adverse events with toxicity grading defined by Cancer Therapy Evaluation Program's (CTEP) v4.0 of National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) scale
Interventions
- DRUG Lenalidomide
- DRUG Poly-ICLC
- BIOLOGICAL Peptides
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 13 participants |
| Start Date | 2016-04 |
| Est. Completion | 2020-06-08 |
| Phase | Phase 1 |
What the finished NCT02721043 record still lists
NCT02721043 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 13 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (78% lower).
The record links to 0 conditions, and to 3 interventions - of which Lenalidomide is the first listed.
NCT02721043 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02721043 about?
NCT02721043 is a clinical study titled "Safety and Immunogenicity of Personalized Genomic Vaccine to Treat Malignancies". The purpose of this study is to test the safety, tolerability, and immunogenicity of Personalized Genomic Vaccine 001 (PGV001) in subjects with advanced non-hematologic malignancies. PGV001 is a peptide vaccine that is based on a patient's own tumor sequence. Each patient's tumor is sequenced and pe...
What is the current status of trial NCT02721043?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 13 participants. The study started on 2016-04. Estimated completion is 2020-06-08.
What interventions are being tested in trial NCT02721043?
The interventions under investigation include: Lenalidomide (DRUG), Poly-ICLC (DRUG), Peptides (BIOLOGICAL).
Who is sponsoring clinical trial NCT02721043?
This trial is sponsored by Nina Bhardwaj, which has 7 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02721043's enrollment target sits among peer trials
13 1847th of 2000 higher than 149 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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