nctId: NCT06324240 id: STUDY00004185 id: NCI-2022-01950 type: REGISTRY domain: CTRP (Clinical Trial Reporting Program) id: STUDY00004185 type: OTHER domain: Emory University Hospital/Winship Cancer Institute id: WINSHIP5522-22 type: OTHER domain: Emory University Hospital/Winship Cancer Institute id: P30CA138292 type: NIH link: https://reporter.nih.gov/quickSearch/P30CA138292 id: R44CA257278 type: NIH link: https://reporter.nih.gov/quickSearch/R44CA257278 briefTitle: Personalized Vaccine Immunotherapy in Combination With Checkpoint Inhibitor for Treatment of Triple Negative Breast Cancer overallStatus: NOT_YET_RECRUITING date: 2024-06-01 date: 2026-12-31 date: 2026-12-31 date: 2024-03-21 date: 2024-03-28 name: Emory University class: OTHER name: National Cancer Institute (NCI) briefSummary: 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. conditions: Anatomic Stage I Breast Cancer AJCC v8 conditions: Anatomic Stage IA Breast Cancer AJCC v8 conditions: Anatomic Stage IB Breast Cancer AJCC v8 conditions: Anatomic Stage II Breast Cancer AJCC v8 conditions: Anatomic Stage IIA Breast Cancer AJCC v8 conditions: Anatomic Stage IIB Breast Cancer AJCC v8 conditions: Anatomic Stage III Breast Cancer AJCC v8 conditions: Anatomic Stage IIIA Breast Cancer AJCC v8 conditions: Anatomic Stage IIIB Breast Cancer AJCC v8 conditions: Anatomic Stage IIIC Breast Cancer AJCC v8 conditions: Anatomic Stage IV Breast Cancer AJCC v8 conditions: Early Stage Triple-Negative Breast Carcinoma conditions: Locally Advanced Triple-Negative Breast Carcinoma conditions: Metastatic Triple-Negative Breast Carcinoma conditions: Prognostic Stage I Breast Cancer AJCC v8 conditions: Prognostic Stage IA Breast Cancer AJCC v8 conditions: Prognostic Stage IB Breast Cancer AJCC v8 conditions: Prognostic Stage II Breast Cancer AJCC v8 conditions: Prognostic Stage IIA Breast Cancer AJCC v8 conditions: Prognostic Stage IIB Breast Cancer AJCC v8 conditions: Prognostic Stage III Breast Cancer AJCC v8 conditions: Prognostic Stage IIIA Breast Cancer AJCC v8 conditions: Prognostic Stage IIIB Breast Cancer AJCC v8 conditions: Prognostic Stage IIIC Breast Cancer AJCC v8 conditions: Prognostic Stage IV Breast Cancer AJCC v8 conditions: Recurrent Breast Carcinoma conditions: Unresectable Triple-Negative Breast Carcinoma studyType: INTERVENTIONAL phases: PHASE1 allocation: RANDOMIZED interventionModel: SEQUENTIAL primaryPurpose: TREATMENT masking: NONE count: 18 type: ESTIMATED name: Ipilimumab name: Pembrolizumab name: Vaccine Therapy measure: Incidence of adverse events (Phase Ia) measure: Dose limiting toxicity (Phase Ia) measure: Immune stimulating activity- T cell activity measure: Immune stimulating activity- Plasma cytokine/chemokines measure: Optimal biologic dose measure: Recommended phase 2 dose (Phase Ib) measure: Disease control rate measure: Overall response rate (ORR) measure: Progression free survival measure: Overall survival measure: PD-L1 expression measure: TIL density measure: BRCA 1/2 mutation status sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Grady Health System city: Atlanta state: Georgia zip: 30303 country: United States lat: 33.749 lon: -84.38798 facility: Emory University Hospital Midtown city: Atlanta state: Georgia zip: 30308 country: United States name: Deborah Omoyege role: CONTACT email: deborah.omoyege@emory.edu name: Keerthi Gogineni, MD, MSHP role: PRINCIPAL_INVESTIGATOR lat: 33.749 lon: -84.38798 facility: Emory University Hospital/Winship Cancer Institute city: Atlanta state: Georgia zip: 30322 country: United States name: Deborah Omoyege role: CONTACT email: deborah.omoyege@emory.edu name: Keerthi Gogineni, MD, MSHP role: PRINCIPAL_INVESTIGATOR lat: 33.749 lon: -84.38798 facility: Emory Saint Joseph's Hospital city: Atlanta state: Georgia zip: 30342 country: United States name: Deborah Omoyege role: CONTACT email: deborah.omoyege@emory.edu name: Keerthi Gogineni, MD, MSHP role: PRINCIPAL_INVESTIGATOR lat: 33.749 lon: -84.38798 hasResults: False