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NCT03162224 · ClinicalTrials.gov registry record · Phase 1
Safety and Efficacy of MEDI0457 and Durvalumab in Participants With Human Papilloma Virus (HPV) Associated Recurrent/Metastatic Head and Neck Cancer
A Phase 1 study of Head and Neck Cancer and Human Papilloma Virus, sponsored by MedImmune.
- Completed
- Registry status
- Phase 1
- Development phase
- 35
- Enrollment target
- 14
- Study locations
NCT03162224: Completed Phase 1 study of Head and Neck Cancer and Human Papilloma Virus, sponsored by MedImmune.
NCT03162224 is a Phase 1 study of Head and Neck Cancer and Human Papilloma Virus that has completed, run by MedImmune. The registered enrollment target is 35 participants, below the 261-participant average among 250 other Head and Neck Cancer trials with a reported enrollment target (87% lower). The trial reports 14 study locations across 13 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03162224, a Phase 1 study of Head and Neck Cancer and Human Papilloma Virus, has completed, sponsored by MedImmune.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 35 participants
- Enrollment target
- 14
- Study locations
Study Summary
This is a Phase 1b/2a, open-label, multi-center study to evaluate the safety and tolerability, anti-tumor activity, and immunogenicity of MEDI0457 (also known as INO 3112) a HPV Deoxyribonucleic Acid (DNA) vaccine in combination with durvalumab (also known as MEDI4736) which is a human monoclonal antibody directed against Programmed Death Ligand 1 (PD-L1), which blocks the interaction of PD-L1 with PD-1 and Cluster of differentiation 80 (CD80). An initial three to 12 participants (Safety Analysis Run-in participants) will be enrolled and assessed for safety before additional participants are enrolled. The initial safety analysis run-in participants along with an approximate total of 50 participants with human papilloma virus associated recurrent or metastatic head and neck squamous cell cancer (HNSCC) will be enrolled in this study and evaluated also for anti-tumor efficacy to MEDI0457 in combination with durvalumab.
Primary Outcome
An AE is any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. A serious adverse event (SAE) is an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. The TEAEs are defined as events present at baseline that wo
Conditions Studied
Interventions
- DRUG Durvalumab
- DRUG MEDI0457
- DEVICE CELLECTRA®5P device
Study Locations (14)
Maryland
- Research Site - Baltimore
- Research Site - Baltimore
California
- Research Site - San Francisco
Florida
- Research Site - Orlando
Georgia
- Research Site - Atlanta
Indiana
- Research Site - Indianapolis
Michigan
- Research Site - Detroit
Minnesota
- Research Site - Minneapolis
Missouri
- Research Site - St Louis
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 35 participants |
| Start Date | 2017-06-26 |
| Est. Completion | 2021-03-19 |
| Phase | Phase 1 |
What the finished NCT03162224 record still lists
NCT03162224 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 35 participants, a relatively small participant target, below the 261-participant average among 250 other Head and Neck Cancer trials with a reported enrollment target (87% lower).
The record links to 2 conditions, with Head and Neck Cancer appearing as the primary indexed condition, and to 3 interventions - of which Durvalumab is the first listed.
NCT03162224 lists 14 locations in 13 states (Maryland, California, Florida).
Frequently Asked Questions
What is clinical trial NCT03162224 about?
NCT03162224 is a clinical study titled "Safety and Efficacy of MEDI0457 and Durvalumab in Participants With Human Papilloma Virus (HPV) Associated Recurrent/Metastatic Head and Neck Cancer". This is a Phase 1b/2a, open-label, multi-center study to evaluate the safety and tolerability, anti-tumor activity, and immunogenicity of MEDI0457 (also known as INO 3112) a HPV Deoxyribonucleic Acid (DNA) vaccine in combination with durvalumab (also known as MEDI4736) which is a human monoclonal an...
What is the current status of trial NCT03162224?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 35 participants. The study started on 2017-06-26. Estimated completion is 2021-03-19.
What conditions does trial NCT03162224 study?
This clinical trial studies the following conditions: Head and Neck Cancer, Human Papilloma Virus.
What interventions are being tested in trial NCT03162224?
The interventions under investigation include: Durvalumab (DRUG), MEDI0457 (DRUG), CELLECTRA®5P device (DEVICE).
Who is sponsoring clinical trial NCT03162224?
This trial is sponsored by MedImmune, which has 210 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03162224 being conducted?
This trial has 14 study locations across California, Florida, Georgia, Indiana, Maryland. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT03162224's enrollment target sits among peer trials
35 165th of 250 higher than 83 of 250 other Head and Neck Cancer trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Head and Neck Cancer 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.
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