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

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

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• DNA Plasmid-encoding Interleukin-12/HPV DNA Plasmids Therapeutic Vaccine MEDI0457 — BIOLOGICAL
  Given IM and via electroporation
• Durvalumab — BIOLOGICAL
  Given IV

Study Details

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.

Key Dates

Start date

Nov 14, 2018

Status verified

May 2024

Primary completion

Sep 20, 2022

Completion

Sep 20, 2022

Study Design

Enrollment

41 participants (actual)

Allocation

NA

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Arms

• Experimental: Treatment (INO-3112, durvalumab)
  Patients receive DNA plasmid-encoding interleukin-12/HPV DNA plasmids therapeutic vaccine INO-3112 IM and via electroporation at 1, 3, 7, and 12 weeks and durvalumab IV at 4, 8, and 12 weeks. Starting week 12, cycles repeat every 8 weeks for DNA plasmid-encoding interleukin-12/HPV DNA plasmids therapeutic vaccine INO-3112 and every 4 weeks for up to 13 doses of durvalumab in the absence of disease progression or unacceptable toxicity.

Primary Outcome Measure

Overall Response Rate (ORR) [ Time Frame: Up to 2 years ]

Locations (1)

Find similar trials in Houston, TX

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