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NCT03633110 · ClinicalTrials.gov registry record · Phase 1
Safety, Tolerability, Immunogenicity, and Antitumor Activity of GEN-009 Adjuvanted Vaccine
A Phase 1 study, sponsored by Genocea Biosciences.
- Completed
- Registry status
- Phase 1
- Development phase
- 24
- Enrollment target
NCT03633110 is a Phase 1 study that has completed, run by Genocea Biosciences. The registered enrollment target is 24 participants.
The verdict
NCT03633110, a Phase 1 study, has completed, sponsored by Genocea Biosciences.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 24 participants
- Enrollment target
Study Summary
In this study, Genocea is evaluating an investigational, personalized adjuvanted vaccine, GEN-009, that is being developed for the treatment of patients with solid tumors. A proprietary tool developed by Genocea, called ATLAS™ (Antigen Lead Acquisition System) will be used to identify neoantigens in each patient's tumor that are recognized by their CD4 and/or CD8 T cells. ATLAS-identified neoantigens will then be incorporated into a patient's personalized vaccine in the form of synthetic long peptides (SLPs).
Interventions
- DRUG Pembrolizumab
- DRUG Nivolumab
- BIOLOGICAL GEN-009 Adjuvanted Vaccine
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 24 participants |
| Start Date | 2018-08-29 |
| Est. Completion | 2022-02-28 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03633110
The ClinicalTrials.gov registry entry for NCT03633110 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 24 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Genocea Biosciences, which has 9 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 3 interventions - of which Pembrolizumab is the first listed.
NCT03633110 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT03633110 about?
NCT03633110 is a clinical study titled "Safety, Tolerability, Immunogenicity, and Antitumor Activity of GEN-009 Adjuvanted Vaccine". In this study, Genocea is evaluating an investigational, personalized adjuvanted vaccine, GEN-009, that is being developed for the treatment of patients with solid tumors. A proprietary tool developed by Genocea, called ATLAS™ (Antigen Lead Acquisition System) will be used to identify neoantigens in...
What is the current status of trial NCT03633110?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 24 participants. The study started on 2018-08-29. Estimated completion is 2022-02-28.
What interventions are being tested in trial NCT03633110?
The interventions under investigation include: Pembrolizumab (DRUG), Nivolumab (DRUG), GEN-009 Adjuvanted Vaccine (BIOLOGICAL).
Who is sponsoring clinical trial NCT03633110?
This trial is sponsored by Genocea Biosciences, which has 9 total clinical trials registered on ClinicalTrials.gov.
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