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Spots Global Cancer Trial Database for INO-3107 With Electroporation (EP) in Participants With HPV-6- and/or HPV-11-Associated Recurrent Respiratory Papillomatosis (RRP)

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Trial Identification

Brief Title: INO-3107 With Electroporation (EP) in Participants With HPV-6- and/or HPV-11-Associated Recurrent Respiratory Papillomatosis (RRP)

Official Title: An Open-label Multi-center Study of INO-3107 With Electroporation (EP) in Subjects With HPV-6- and/or HPV-11-associated Recurrent Respiratory Papillomatosis (RRP)

Study ID: NCT04398433

Study Description

Brief Summary: This is a Phase 1/2 open-label, multicenter trial to evaluate the safety, tolerability, immunogenicity, and efficacy of INO-3107 in subjects with HPV-6 and/or HPV-11-associated recurrent respiratory papillomatosis (RRP). The trial population will include participants who have been diagnosed with either Juvenile-Onset RRP (J-O RRP) as defined by age at first diagnosis \<12 years or with Adult- Onset RRP (A-O RRP) as defined by age at first diagnosis ≥12 years. A safety run-in will be performed with up to six participants with a one week waiting period between each enrolled participant.

Detailed Description:

Eligibility

Minimum Age: 18 Years

Eligible Ages: ADULT, OLDER_ADULT

Sex: ALL

Healthy Volunteers: No

Locations

Mayo Clinic Arizona, Phoenix, Arizona, United States

University of California at Davis, Sacramento, California, United States

Winship at Emory University Hospital Midtown, Atlanta, Georgia, United States

Johns Hopkins University School of Medicine, Baltimore, Maryland, United States

Washington University School of Medicine, Saint Louis, Missouri, United States

NYU Langone Voice Center, New York, New York, United States

UNC School of Medicine, Chapel Hill, North Carolina, United States

Cincinnati Children's Hospital, Cincinnati, Ohio, United States

University of Cincinnati Medical Center, Cincinnati, Ohio, United States

UT Southwestern Medical Center, Dallas, Texas, United States

Baylor College of Medicine, Houston, Texas, United States

Contact Details

Name: Jeffrey Skolnik, MD

Affiliation: Inovio Pharmaceuticals

Role: STUDY_DIRECTOR

Useful links and downloads for this trial

Clinicaltrials.gov

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