The research study is being conducted to test an experimental vaccine to potentially prevent cancer for people with BRCA1 or BRCA2 mutations. This study will test if the vaccine is safe (without significant side effects) and test a new way of administering vaccines. It will also test whether the vaccine activates your immune system.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Signed and dated IRB approved informed consent.
. Females and males age 18+.
. Documented carrier of a pathogenic or likely pathogenic mutation in BRCA1 or BRCA2.
. Diagnosis of invasive breast cancer, invasive ovarian cancer, pancreatic cancer (apart from neuroendocrine) or prostate cancer with completion of adjuvant therapy and no clinical evidence of disease according to standard of care.
. Minimum of 2 clear sites on the skin to allow for injection.
. ECOG performance status of 0.
. Normal ECG or ECG without clinically significant findings and which does not require clinical action.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Dose Limiting Toxicities
Timeframe: for 2 years after last dose of study treatment
. Normal bone marrow, hepatic, and renal function.
Exclusion criteria
. Previous treatment with INO-5401 or IL-12 containing therapy, or any other DNA immunotherapy.
. Prior history of invasive cancer other than those listed above. History of localized superficial non-melanoma skin cancers, melanoma in situ, cervical intraepithelial neoplasia, or breast ductal carcinoma in situ is allowed.
. Pregnant or breast-feeding subjects.
. Participation in other studies involving investigational drug(s) within 4 weeks prior to study entry and/or during study participation; continued participation in an observational study is allowed.
. Cardiac pre-excitation syndromes.
. Prior major surgery within 4 weeks of first study treatment.
. Presence of acute or chronic bleeding or clotting disorder that would contraindicate intramuscular injections or use of blood thinners within 2 weeks of first study treatment.
. Any concurrent condition requiring the continued or anticipated use of systemic steroids or immunosuppressive therapy. All systemic corticosteroids must be discontinued at least 4 weeks prior to first study treatment.