protocolSection identificationModule nctId: NCT06324240, orgStudyIdInfo id: STUDY00004185, secondaryIdInfos id: NCI-2022-01950, type: REGISTRY, domain: CTRP (Clinical Trial Reporting Program), secondaryIdInfos id: STUDY00004185, type: OTHER, domain: Emory University Hospital/Winship Cancer Institute, secondaryIdInfos id: WINSHIP5522-22, type: OTHER, domain: Emory University Hospital/Winship Cancer Institute, secondaryIdInfos id: P30CA138292, type: NIH, link: https://reporter.nih.gov/quickSearch/P30CA138292, secondaryIdInfos 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, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-06-01, primaryCompletionDateStruct date: 2026-12-31, completionDateStruct date: 2026-12-31, studyFirstPostDateStruct date: 2024-03-21, lastUpdatePostDateStruct date: 2024-03-28, sponsorCollaboratorsModule leadSponsor name: Emory University, class: OTHER, collaborators name: National Cancer Institute (NCI), descriptionModule 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., conditionsModule 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, designModule studyType: INTERVENTIONAL, phases: PHASE1, designInfo allocation: RANDOMIZED, interventionModel: SEQUENTIAL, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 18, type: ESTIMATED, armsInterventionsModule interventions name: Ipilimumab, interventions name: Pembrolizumab, interventions name: Vaccine Therapy, outcomesModule primaryOutcomes measure: Incidence of adverse events (Phase Ia), primaryOutcomes measure: Dose limiting toxicity (Phase Ia), secondaryOutcomes measure: Immune stimulating activity- T cell activity, secondaryOutcomes measure: Immune stimulating activity- Plasma cytokine/chemokines, secondaryOutcomes measure: Optimal biologic dose, secondaryOutcomes measure: Recommended phase 2 dose (Phase Ib), secondaryOutcomes measure: Disease control rate, secondaryOutcomes measure: Overall response rate (ORR), secondaryOutcomes measure: Progression free survival, secondaryOutcomes measure: Overall survival, otherOutcomes measure: PD-L1 expression, otherOutcomes measure: TIL density, otherOutcomes measure: BRCA 1/2 mutation status, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Grady Health System, city: Atlanta, state: Georgia, zip: 30303, country: United States, geoPoint lat: 33.749, lon: -84.38798, locations facility: Emory University Hospital Midtown, city: Atlanta, state: Georgia, zip: 30308, country: United States, contacts name: Deborah Omoyege, role: CONTACT, email: deborah.omoyege@emory.edu, contacts name: Keerthi Gogineni, MD, MSHP, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 33.749, lon: -84.38798, locations facility: Emory University Hospital/Winship Cancer Institute, city: Atlanta, state: Georgia, zip: 30322, country: United States, contacts name: Deborah Omoyege, role: CONTACT, email: deborah.omoyege@emory.edu, contacts name: Keerthi Gogineni, MD, MSHP, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 33.749, lon: -84.38798, locations facility: Emory Saint Joseph's Hospital, city: Atlanta, state: Georgia, zip: 30342, country: United States, contacts name: Deborah Omoyege, role: CONTACT, email: deborah.omoyege@emory.edu, contacts name: Keerthi Gogineni, MD, MSHP, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 33.749, lon: -84.38798, hasResults: False