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Therapy for High-Risk HPV 16-Positive Oropharynx Cancer Patients

NCT04001413 · Status: WITHDRAWN · Phase: PHASE2 · Type: INTERVENTIONAL

Last updated 2022-07-29

No results posted yet for this study

Summary

Combination immune checkpoint inhibitor and DNA vaccine will result in clearance of HPV DNA biomarkers (oral and/or plasma) for patients with persistent HPV-16 E6/E7 DNA (HPV biomarker) after treatment with curative intent.

Conditions

  • HPV Positive Oropharyngeal Squamous Cell Carcinoma
  • Oropharynx Cancer
  • HPV-Related Carcinoma

Interventions

DRUG

MEDI0457

MEDI0457 is an investigational drug that will be administered with the Cellectra Device in this study

DRUG

Durvalumab

Durvalumab is an investigational drug in this study.

Sponsors & Collaborators

  • AstraZeneca

    collaborator INDUSTRY

  • Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

    lead OTHER

Principal Investigators

  • Carole Fakhry, MD, MPH · Johns Hopkins University/Sidney Kimmel Cancer Center

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-09-17
Primary Completion
2021-03-25
Completion
2021-03-25
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04001413 on ClinicalTrials.gov