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

Oropharynx Cancer Clinical Trial

Official title: Phase II, Adjuvant Therapy for High-Risk HPV 16-Positive Oropharynx Cancer Patients With Durvalumab (MEDI4736) and MEDI0457 (INO-3112)

Status Withdrawn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 ;

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

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• Status: Withdrawn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