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COMPLETED Phase 1

Safety and Efficacy of MEDI0457 and Durvalumab in Participants With Human Papilloma Virus (HPV) Associated Recurrent/Metastatic Head and Neck Cancer

NCT03162224 · View on ClinicalTrials.gov ↗

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.

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

FieldValue
Enrollment Target 35 participants
Start Date 2017-06-26
Est. Completion 2021-03-19
Phase Phase 1

Sponsor

MedImmune

55 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT03162224

The ClinicalTrials.gov registry entry for NCT03162224 describes a study currently listed as completed. It is categorized as Phase 1, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 35 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is MedImmune, which has 55 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT03162224 reports 14 study locations spanning 13 distinct geographic areas — top geographies include Maryland, California, Florida. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT03162224?

The interventions under investigation include: Durvalumab (DRUG), MEDI0457 (DRUG), CELLECTRA®5P device (DEVICE). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT03162224?

This trial is sponsored by MedImmune, which has 55 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

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.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial