Health Trials

Personalized Vaccine Immunotherapy in Combination With Checkpoint Inhibitor for Treatment of Triple Negative Breast Cancer

ConditionsAnatomic Stage I Breast Cancer AJCC v8Anatomic Stage IA Breast Cancer AJCC v8Anatomic Stage IB Breast Cancer AJCC v8Anatomic Stage II Breast Cancer AJCC v8Anatomic Stage IIA Breast Cancer AJCC v8Anatomic Stage IIB Breast Cancer AJCC v8Anatomic Stage III Breast Cancer AJCC v8Anatomic Stage IIIA Breast Cancer AJCC v8Anatomic Stage IIIB Breast Cancer AJCC v8Anatomic Stage IIIC Breast Cancer AJCC v8Anatomic Stage IV Breast Cancer AJCC v8Early Stage Triple-Negative Breast CarcinomaLocally Advanced Triple-Negative Breast CarcinomaMetastatic Triple-Negative Breast CarcinomaPrognostic Stage I Breast Cancer AJCC v8Prognostic Stage IA Breast Cancer AJCC v8Prognostic Stage IB Breast Cancer AJCC v8Prognostic Stage II Breast Cancer AJCC v8Prognostic Stage IIA Breast Cancer AJCC v8Prognostic Stage IIB Breast Cancer AJCC v8Prognostic Stage III Breast Cancer AJCC v8Prognostic Stage IIIA Breast Cancer AJCC v8Prognostic Stage IIIB Breast Cancer AJCC v8Prognostic Stage IIIC Breast Cancer AJCC v8Prognostic Stage IV Breast Cancer AJCC v8Recurrent Breast CarcinomaUnresectable Triple-Negative Breast Carcinoma
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18+
SponsorEmory University

About this trial

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.

Eligibility criteria

Qualifiers

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)

Disqualifiers

Weight of the tumor tissue is less 1 gram

Clinically significant comorbid conditions such as cardiovascular disease or significant peripheral vascular (e.g., uncontrolled hypertension, myocardial infarction, unstable angina) within 6 months of study entry, serious cardiac arrhythmia requiring medication, and uncontrolled infection

No second malignancy except prior breast cancer or except non-melanomatous skin cancer within the past 5 years

Ongoing or planned systemic anti-cancer therapy or radiation therapy. Last cycle of cytotoxic therapy must be >= 21 days prior to C1D1 of vaccine. Last cycle of checkpoint inhibitor therapy be >= 28 days prior to C1D1 of vaccine. Last dose of radiotherapy must be >= 14 days prior to C1D1 of vaccine

Trial design

Treatments tested in this trial

  • Ipilimumab
  • Pembrolizumab
  • Vaccine Therapy

Treatment groups

18 Participants
are divided into 3 treatment groups

Sponsors and collaborators

Emory University

Lead sponsor

National Cancer Institute (NCI)

Collaborator

Source ClinicalTrials.gov