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Checkpoint Inhibitor

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

Phase 2
Waitlist Available
Led By Michael M Frumovitz
Research Sponsored by M.D. Anderson Cancer Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 2 years
Awards & highlights

Study Summary

This trial is studying a therapeutic vaccine and immunotherapy combination to treat human papillomavirus associated cancers.

Eligible Conditions
  • Human Papillomavirus
  • Anal Cancer
  • Vaginal Cancer
  • Cervical Cancer
  • Penile Cancer
  • Vulvar Cancer
  • Cancer
  • Malignant Neoplasm

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 2 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 2 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Objective response rate (ORR)
Secondary outcome measures
Disease control rate
ORR
Overall survival
+1 more

Trial Design

1Treatment groups
Experimental Treatment
Group I: Treatment (INO-3112, durvalumab)Experimental Treatment2 Interventions
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.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Durvalumab
2017
Completed Phase 2
~3870

Find a Location

Who is running the clinical trial?

M.D. Anderson Cancer CenterLead Sponsor
2,971 Previous Clinical Trials
1,787,139 Total Patients Enrolled
National Cancer Institute (NCI)NIH
13,658 Previous Clinical Trials
40,924,412 Total Patients Enrolled
Michael M FrumovitzPrincipal InvestigatorM.D. Anderson Cancer Center
1 Previous Clinical Trials
750 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What have the findings been regarding MEDI0457's efficacy in preserving human health?

"A score of two was assigned to DNA Plasmid-encoding Interleukin-12/HPV DNA Plasmids Therapeutic Vaccine MEDI0457 due its Phase 2 status, which implies a moderate degree of safety data exists but no proof that it is effective."

Answered by AI

Are there any vacancies still available in this research endeavor?

"At this juncture, the clinical trial is not actively enrolling. The original posting was on November 14th 2018 and has been edited as recently as February 11th 2022. For those interested in other studies, there are 5656 trials for relapse recruitment and 340 active trials related to MEDI0457 DNA Plasmid-encoding Interleukin-12/HPV Therapeutic Vaccine currently recruiting patients."

Answered by AI

To what diseases can MEDI0457 be applied as a therapeutic vaccine?

"Patients with unresectable stage III non-small cell lung cancer can benefit from the use of DNA Plasmid-encoding Interleukin-12/HPV DNA Plasmids Therapeutic Vaccine MEDI0457. This therapeutic vaccine has also proven useful in treating previously untreated metastatic ureter urothelial carcinoma and advanced directives."

Answered by AI

Capacity-wise, how many volunteers can join this medical experiment?

"This clinical trial is no longer accepting participants as it has reached the end of its recruitment period. It was initially posted on November 14th 2018 and last edited on February 11th 2022. Other studies that may be applicable can be found, with 5656 trials actively enrolling patients for relapse and 340 seeking those eligible for MEDI0457's DNA Plasmid-encoding Interleukin-12/HPV DNA Plasmids Therapeutic Vaccine therapy."

Answered by AI

To what extent have other experiments studied the effects of MEDI0457, a DNA Plasmid-encoding Interleukin-12/HPV DNA Plasmids Therapeutic Vaccine?

"Currently, 340 clinical trials are underway to study the efficacy of DNA Plasmid-encoding Interleukin-12/HPV DNA Plasmids Therapeutic Vaccine MEDI0457. Of these studies, 52 have advanced to Phase 3. While most facilities running tests for this vaccine can be found in Cordoba, Texas; 13003 sites across the world are participating in related research."

Answered by AI

Who else is applying?

What state do they live in?
Tennessee
How old are they?
18 - 65
What site did they apply to?
M D Anderson Cancer Center
What portion of applicants met pre-screening criteria?
Met criteria

How responsive is this trial?

Typically responds via
Email
Most responsive sites:
  1. M D Anderson Cancer Center: < 24 hours
Average response time
  • < 1 Day
~12 spots leftby Apr 2025