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

Status Withdrawn

Clinical Trial 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.

Clinical Trial Description

Objectives: Primary Objectives: To determine whether combination immune checkpoint inhibitor, alone or together with a DNA vaccine will result in clearance of HPV biomarkers for patients at risk of disease progression. Secondary Objective(s): 1. To evaluate the time to progression among patients with detectable HPV DNA when treated with the durvalumab/MEDI0457 versus durvalumab monotherapy versus observation. 2. To assess the toxicity of durvalumab and MEDI0457 in the adjuvant setting. Exploratory Objective(s): 1. To determine whether anti-PD-L1 alone or together with an HPV DNA vaccine will enhance HPV E6/E7-specific and/or mutation-associated neoantigen (MANA)-specific T cell responses and whether these responses correlate with enhanced clearance of HPV as measured by DNA in oral rinses and/or plasma. 2. To determine whether anti-PD-L1 alone or together with an HPV DNA vaccine will enhance HPV 16 E6/E7-specific IgG and whether these responses correlate with enhanced clearance of HPV as measured by DNA in oral rinses and/or plasma ;

Study Design

Related Conditions & MeSH terms

Carcinoma
HPV Positive Oropharyngeal Squamous Cell Carcinoma
HPV-Related Carcinoma
Oropharyngeal Neoplasms
Oropharynx Cancer
Squamous Cell Carcinoma of Head and Neck

Clinical Trial Details

NCT number	NCT04001413
Study type	Interventional
Source	Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Contact
Status	Withdrawn
Phase	Phase 2
Start date	September 17, 2019
Completion date	March 25, 2021

View Details

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