Personalized TMV Tumor Vaccine

PRIMARY OBJECTIVES: I. To determine the safety and tolerability of TMV vaccine when delivered intradermally as monotherapy in patients with early stage TNBC for Phase 1a. II. To determine immune stimulating activity and an optimal biological dose (OBD) of TMV vaccine when delivered intradermally as monotherapy for Phase 1a. III.

To determine the safety and tolerability of TMV vaccine under OBD when delivered intradermally in combination with PD-1-inhibitor pembrolizumab or CTLA-4 inhibitor ipilimumab in patients with metastatic TNBC (mTNBC) and patients with early stage TNBC for Phase 1b. SECONDARY OBJECTIVES: I. To determine immune stimulating activity of TMV vaccine when delivered intradermally as in combination with checkpoint inhibitor therapy in adult patients with TNBC (TNBC) for Phase 1b. II.

This phase I trial tests the safety, side effects, and best dose of a personalized vaccine (tumor membrane vesicle or TMV vaccine) by itself and in combination with checkpoint inhibitor (pembrolizumab or ipilimumab) in treating patients with triple negative breast cancer. This vaccine is made by taking a piece of patient's triple negative breast cancer to design a vaccine to stimulate the immune system's memory.

Patients are treated with the personalized vaccine immunotherapy with or without monoclonal antibodies, such as pembrolizumab and ipilimumab. This approach may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Giving personalized TMV vaccine with pembrolizumab or ipilimumab may help the immune system attack cancer better and reduce the risk of this breast cancer coming back or growing.

Live record on ClinicalTrials.gov →

• Written informed consent and Health Insurance Portability and Accountability Act (HIPAA) authorization for release of personal health information
• Must be age >= 18 years
• Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 within 14 days prior to tissue consent
• Absolute neutrophil count > 1500/mcL (obtained within 14 days prior to vaccine administration)
• Absolute lymphocyte count >= 600 cells/µl (obtained within 14 days prior to vaccine administration)
• Platelets > 100,000 mm (obtained within 14 days prior to vaccine administration)

Inclusion criteria as written on the registry, trimmed. The full list, with exclusions, is on the live record.