OncoMatch/Clinical Trials/NCT06324240
Personalized Vaccine Immunotherapy in Combination With Checkpoint Inhibitor for Treatment of Triple Negative Breast Cancer
Is NCT06324240 recruiting? Yes, currently enrolling (May 2026). This Phase 1 trial studies multiple treatments including Ipilimumab and Pembrolizumab for anatomic stage i breast cancer ajcc v8.
Treatment: Ipilimumab · Pembrolizumab · Vaccine Therapy — 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.
Check if I qualifyExtracted eligibility criteria
Cancer type
Breast Carcinoma
Triple-Negative Breast Cancer
Biomarker criteria
Required: ESR1 expression ≤ 10% if Allred ≤ 3 (≤ 10% if Allred ≤ 3)
TNBC as defined by estrogen receptor (ER)/progesterone receptor (PR) ≤ 10% if Allred ≤ 3
Required: PR (PGR) expression ≤ 10% if Allred ≤ 3 (≤ 10% if Allred ≤ 3)
TNBC as defined by estrogen receptor (ER)/progesterone receptor (PR) ≤ 10% if Allred ≤ 3
Required: HER2 (ERBB2) negative (0 or 1+ by IHC, or 2+ by IHC with FISH ratio < 2.0 or < 6 Her2 copies per cell) (0 or 1+ by IHC, or 2+ by IHC with FISH ratio < 2.0 or < 6 Her2 copies per cell)
Her2/neu negative as defined by scores of 0 or 1+ by immunohistochemistry (IHC) or 2+ by IHC associated with a fluorescence in situ hybridization (FISH) ratio of < 2.0 or < 6 Her2 copies per cell
Required: BRCA1 germline deleterious mutation testing required
Patients will undergo germline testing to assess for a BRCA1/BRCA2 deleterious mutation. Knowledge of germline status is not required to enroll on the study
Required: BRCA2 germline deleterious mutation testing required
Patients will undergo germline testing to assess for a BRCA1/BRCA2 deleterious mutation. Knowledge of germline status is not required to enroll on the study
Allowed: PD-L1 (CD274) positive (CPS ≥ 10)
Patients who are known to have PD-L1 positive with combined positive score (CPS) ≥ 10 will be required to have had pembrolizumab therapy prior to enrollment
Disease stage
Required: Stage I, IA, IB, II, IIA, IIB, III, IIIA, IIIB, IIIC, IV
Performance status
ECOG 0–1(Restricted strenuous activity)
Prior therapy
Cannot have received: systemic anti-cancer therapy
Exception: last cycle of cytotoxic therapy ≥ 21 days prior to C1D1 of vaccine; last cycle of checkpoint inhibitor therapy ≥ 28 days prior to C1D1 of vaccine; last dose of radiotherapy ≥ 14 days prior to C1D1 of vaccine
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
Lab requirements
Blood counts
Absolute neutrophil count > 1500/mcL; Absolute lymphocyte count ≥ 600 cells/µl; Platelets > 100,000 mm; Hemoglobin > 9.0 g/dL (transfusion or other intervention to achieve Hgb > 9.0g/dl is acceptable); INR or PT ≤ 1.5 x ULN unless patient is receiving anticoagulant therapy as long as PT or PTT is within therapeutic range of intended use of anticoagulants; aPTT ≤ 1.5 x ULN unless patient is receiving anticoagulant therapy as long as PT or PTT is within therapeutic range of intended use of anticoagulants
Kidney function
Serum creatinine ≤ 1.5 x ULN or calculated creatinine clearance ≥ 60 mL/min using Cockcroft-Gault equation for patients with creatinine levels > 1.5 x institutional ULN
Liver function
Total bilirubin ≤ 1.5 x ULN OR direct bilirubin ≤ 1 x ULN; AST and ALT ≤ 2.5 x ULN unless liver metastases are present, in which case ≤ 5 x ULN; Bilirubin ≤ 1.5 X ULN (except in participants with documented Gilbert's disease, who must have a total bilirubin ≤ 3.0 mg/dL)
Absolute neutrophil count > 1500/mcL... Absolute lymphocyte count ≥ 600 cells/µl... Platelets > 100,000 mm... Hemoglobin > 9.0 g/dL... Serum creatinine ≤ 1.5 x ULN or calculated creatinine clearance ≥ 60 mL/min... Total bilirubin ≤ 1.5 x ULN OR direct bilirubin ≤ 1 x ULN... AST and ALT ≤ 2.5 x ULN unless liver metastases are present, in which case ≤ 5 x ULN... Bilirubin ≤ 1.5 X ULN (except in participants with documented Gilbert's disease, who must have a total bilirubin ≤ 3.0 mg/dL)... INR or PT ≤ 1.5 x ULN unless patient is receiving anticoagulant therapy as long as PT or PTT is within therapeutic range of intended use of anticoagulants... aPTT ≤ 1.5 x ULN unless patient is receiving anticoagulant therapy as long as PT or PTT is within therapeutic range of intended use of anticoagulants
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- Grady Health System · Atlanta, Georgia
- Emory University Hospital Midtown · Atlanta, Georgia
- Emory University Hospital/Winship Cancer Institute · Atlanta, Georgia
- Emory Saint Joseph's Hospital · Atlanta, Georgia
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