DNA Plasmid-encoding Interleukin-12/HPV DNA Plasmids Therapeutic Vaccine INO-3112 and Durvalumab in Treating Patients With Recurrent or Metastatic Human Papillomavirus Associated Cancers
Public ClinicalTrials.gov record NCT03439085. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
A Phase 2, Open-Label Study to Evaluate Efficacy of Combination Treatment With MEDI0457 (INO-3112) and Durvalumab (MEDI4736) in Patients With Recurrent/Metastatic Human Papilloma Virus Associated Cancers
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
This phase II trial studies how well deoxyribonucleic acid (DNA) plasmid-encoding interleukin-12/human papillomavirus (HPV) DNA plasmids therapeutic vaccine INO-3112 and durvalumab work in treating patients with human papillomavirus associated cancers that have come back or spread to other places in the body. Vaccines made from a gene-modified virus may help the body build an effective immune response to kill tumor cells. Immunotherapy with monoclonal antibodies, such as durvalumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Giving DNA plasmid-encoding interleukin-12/HPV DNA plasmids therapeutic vaccine INO-3112 and durvalumab may work better in treating patients with human papillomavirus associated cancers.
Study identification
- NCT ID
- NCT03439085
- Recruitment status
- Terminated
- Study type
- Interventional
- Phase
- Phase 2
- Enrollment
- 41 participants
Conditions and interventions
Conditions
- Human Papillomavirus-16 Positive
- Human Papillomavirus-18 Positive
- Metastatic Malignant Neoplasm
- Recurrent Anal Canal Carcinoma
- Recurrent Cervical Carcinoma
- Recurrent Malignant Neoplasm
- Recurrent Penile Carcinoma
- Recurrent Vaginal Carcinoma
- Recurrent Vulvar Carcinoma
- Refractory Malignant Neoplasm
- Stage IV Anal Cancer AJCC v8
- Stage IV Cervical Cancer AJCC v8
- Stage IV Penile Cancer AJCC v8
- Stage IV Vaginal Cancer AJCC v8
- Stage IV Vulvar Cancer AJCC v8
- Stage IVA Cervical Cancer AJCC v8
- Stage IVA Vaginal Cancer AJCC v8
- Stage IVA Vulvar Cancer AJCC v8
- Stage IVB Cervical Cancer AJCC v8
- Stage IVB Vaginal Cancer AJCC v8
- Stage IVB Vulvar Cancer AJCC v8
Interventions
- DNA Plasmid-encoding Interleukin-12/HPV DNA Plasmids Therapeutic Vaccine MEDI0457 Biological
- Durvalumab Biological
Biological
Eligibility (public fields only)
- Age range
- 18 Years and older
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Nov 13, 2018
- Primary completion
- Sep 19, 2022
- Completion
- Sep 19, 2022
- Last update posted
- Jul 8, 2024
2018 – 2022
United States locations
- U.S. sites
- 1
- U.S. states
- 1
- U.S. cities
- 1
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| M D Anderson Cancer Center | Houston | Texas | 77030 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT03439085, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Jul 8, 2024 · Synced Sep 5, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT03439085 live on ClinicalTrials.gov.