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

Part of paid clinical trials in Baltimore, Maryland.

Sponsor
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Study ID
NCT04001413
Phase
PHASE2
Status
Withdrawn

Conditions

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

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • MEDI0457 — DRUG
    MEDI0457 is an investigational drug that will be administered with the Cellectra Device in this study
  • Durvalumab — DRUG
    Durvalumab is an investigational drug in this study.

Study Details

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.

Key Dates

Start date
Sep 17, 2019
Status verified
Jul 2022
Primary completion
Mar 25, 2021
Completion
Mar 25, 2021

Study Design

Enrollment
0 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • No Intervention: Arm A: Observational
    No intervention, observational arm.
  • Experimental: Arm B: Durvalumab Alone
    Durvalumab will be administered as an IV Infusion.
  • Experimental: Arm C: MEDI0457 and Durvalumab
    MEDI0457 is an injection. Durvalumab will be administered as an IV Infusion.

Primary Outcome Measure

Number of participants in whom there is clearance of Human Papiloma Virus (HPV) biomarkers post-intervention [ Time Frame: Up to 5 years ]

Locations (4)

FacilityCityStateZIPSite coordinators
Johns Hopkins UniversityBaltimoreMaryland21287-
Mount Sinai School of MedicineNew YorkNew York10029-
Mount Sinai School of Medicine, The Tisch Cancer InstituteNew YorkNew York10029-
University of PennsylvaniaPhiladelphiaPennsylvania19104-

Find similar trials in Baltimore, MD

By research site
Johns Hopkins University· Baltimore, MDMount Sinai School of Medicine· New York, NYMount Sinai School of Medicine, The Tisch Cancer Institute· New York, NYUniversity of Pennsylvania· Philadelphia, PA

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