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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 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.

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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.

Conditions Studied

Head and Neck Cancer Human Papilloma Virus

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

210 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, categorized as Phase 1. The registered enrollment target is 35 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 261-participant average among 250 other Head and Neck Cancer trials with a reported enrollment target (87% lower). The listed sponsor is MedImmune, which has 210 total studies on file at ClinicalTrials.gov.

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 reports 14 study locations spanning 13 distinct geographic areas - top geographies include 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.

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Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.