Testing a Vaccine for Cancer Prevention in People with a BRCA1 or BRCA2 Mutation

About the Study

This study will look at a new vaccine known as INO-5401 used alone or combined with a second vaccine called INO-9012. The study will test if the vaccine is safe (without large side effects) and test a new way of giving vaccines. It will also test whether the vaccine activates the immune system. A goal of this research is to reduce cancer risk in people with a BRCA1 or BRCA2 mutation. Additional studies will be needed to learn if this vaccine approach lowers cancer risk in mutation carriers. 

Type of Study

This is an early-phase, open-label, 2-group study.

• In an open-label study, all patients will know which vaccine they are receiving.
• There are two separate groups, one group will receive one vaccine, and a second group receive both vaccines.

What the Study Entails

• Participants will be assigned to one of two groups.
  • One group will receive the INO-5401 vaccine.
  • One group will receive the INO-5401 vaccine combined with the INO-9012 vaccine.
• Both groups will receive a small electric surge using small needles to increase the amount of the study vaccine taken in by the cells.
• Both groups will receive injections with the electric surge every 4 weeks for 4 cycles.
• All participants will be followed for 2 years after the last dose of the study agent.

Study Site

Pennsylvania
University of Pennsylvania      
Philadelphia, PA
Contact: Alex Torres by Phone: 855-216-0098
or by email at: PennCancerTrials@emergingmed.com   

People 18 years or older with the following may be eligible participate:

• Participants must have a BRCA1 or BRCA2 mutation.
• Female participants must be post-menopausal.
• Male participants must be willing to use a condom with female partners who are of reproductive age and their female sexual partners should use an additional highly effective method of birth control. This is required from screening through 24 weeks after the last vaccine dose.
• People who were previously diagnosed with cancer may be eligible if they:
  • completed therapy.
  • were diagnosed with breast, ovarian, pancreatic, or prostate cancer.
  • have no evidence of disease.
• People who have had risk-reducing mastectomy and/or salpingo-oophorectomy may be eligible.

Contact study team for additional eligibility. 

People with the following may not be eligible to participate:

• Have previous received INO-5401 or IL-12 containing therapy, or any other DNA immunotherapy.
• Had a diagnosis of any cancer other than those listed in the Inclusion criteria. Contact the study team for a list of exceptions.
• Have an abnormal heart rhythm. 
• Have been diagnosed with HIV, hepatitis B and/or hepatitis C.
• Have metal implants close to the planned site of injection in the upper arm.

Contact study team for additional eligibility.