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 range18 Years
SexALL
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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.
✓. 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.
What they're measuring
1
Dose Limiting Toxicities
Timeframe: for 2 years after last dose of study treatment
✕. 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.