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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 is a Phase 1 study that has completed, run by Nina Bhardwaj. The registered enrollment target is 13 participants.
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02721043
The ClinicalTrials.gov registry entry for NCT02721043 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 13 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Nina Bhardwaj, which has 7 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 3 interventions - of which Lenalidomide is the first listed.
NCT02721043 reports 0 study locations.
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.
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