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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

NCT03439085 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 41

Last updated 2024-07-09

Study results available
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Summary

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.

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

BIOLOGICAL

DNA Plasmid-encoding Interleukin-12/HPV DNA Plasmids Therapeutic Vaccine MEDI0457

Given IM and via electroporation

BIOLOGICAL

Durvalumab

Given IV

Sponsors & Collaborators

  • National Cancer Institute (NCI)

    collaborator NIH

  • M.D. Anderson Cancer Center

    lead OTHER

Principal Investigators

  • Michael M Frumovitz · M.D. Anderson Cancer Center

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-11-14
Primary Completion
2022-09-20
Completion
2022-09-20
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03439085 on ClinicalTrials.gov