Trials / Withdrawn
WithdrawnNCT04001413
Therapy for High-Risk HPV 16-Positive Oropharynx Cancer Patients
Phase II, Adjuvant Therapy for High-Risk HPV 16-Positive Oropharynx Cancer Patients With Durvalumab (MEDI4736) and MEDI0457 (INO-3112)
- Status
- Withdrawn
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 0 (actual)
- Sponsor
- Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins · Academic / Other
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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.
Detailed 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
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| 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. |
Timeline
- Start date
- 2019-09-17
- Primary completion
- 2021-03-25
- Completion
- 2021-03-25
- First posted
- 2019-06-28
- Last updated
- 2022-07-29
Locations
4 sites across 1 country: United States
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT04001413. Inclusion in this directory is not an endorsement.