Clinical Trials Directory

Trials / Terminated

TerminatedNCT03439085

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

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

Status
Terminated
Phase
Phase 2
Study type
Interventional
Enrollment
41 (actual)
Sponsor
M.D. Anderson Cancer Center · Academic / Other
Sex
All
Age
18 Years
Healthy volunteers
Not accepted

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.

Detailed description

PRIMARY OBJECTIVES: I. To evaluate the anti-tumor activity of DNA plasmid-encoding interleukin-12/HPV DNA plasmids therapeutic vaccine INO-3112 (MEDI0457) in combination with durvalumab. SECONDARY OBJECTIVES: I. To determine the safety profile of MEDI0457 in combination with durvalumab in patients with recurrent/metastatic human papilloma virus (HPV) 16- or 18- associated cancer. II. To evaluate the progression-free survival (PFS) and overall survival (OS) of patients with recurrent/metastatic incurable HPV-16/18 positive solid malignancies receiving the combination of MEDI0457and durvalumab. III. To evaluate objective response rate (ORR) by immune-related criteria of the combination of MEDI0457 and durvalumab in patients with recurrent/metastatic incurable HPV-16/18 positive solid malignancies. IV. To evaluate the disease control rate at 24 weeks. EXPLORATORY OBJECTIVES: I. To determine the cellular and humoral immune response to immunotherapy with MEDI0457 in combination with durvalumab, II. To examine the correlation between anti tumor activity and biomarkers including: IIa. HPV-specific cellular and humoral responses. IIb. Programmed death ligand 1 status. IIc. The number of tumor infiltrating lymphocytes, HPV 16/18 E6/E7 deoxyribonucleic acid (DNA) levels and HPV 16/18 E6/E7 DNA sequence in biopsy tissue and plasma. III. To evaluate the pharmacokinetics and anti-drug antibodies (ADA) for durvalumab. OUTLINE: Patients receive DNA plasmid-encoding interleukin-12/HPV DNA plasmids therapeutic vaccine INO-3112 intramuscularly (IM) and via electroporation at 1, 3, 7, and 12 weeks and durvalumab intravenously (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. After completion of study treatment, patients are followed up at 90 days, every 3 months for 12 months, and then every 6 months thereafter.

Conditions

Interventions

TypeNameDescription
BIOLOGICALDNA Plasmid-encoding Interleukin-12/HPV DNA Plasmids Therapeutic Vaccine MEDI0457Given IM and via electroporation
BIOLOGICALDurvalumabGiven IV

Timeline

Start date
2018-11-14
Primary completion
2022-09-20
Completion
2022-09-20
First posted
2018-02-20
Last updated
2024-07-09
Results posted
2024-07-09

Locations

1 site across 1 country: United States

Regulatory

Source: ClinicalTrials.gov record NCT03439085. Inclusion in this directory is not an endorsement.