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New treatment option for Anatomic Stage I Breast Cancer AJCC v8
Official title Personalized Vaccine Immunotherapy in Combination With Checkpoint Inhibitor for Treatment of Triple Negative Breast Cancer
ClinicalTrials.gov ID: NCT06324240
What this study is testing
What is Ipilimumab?
Ipilimumab is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for anatomic stage i breast cancer ajcc v8.
Also referred to as Anti-Cytotoxic T-Lymphocyte-Associated Antigen-4 Monoclonal Antibody, BMS-734016.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 1: an early, usually small safety study
- Time commitment: about 2 years
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- 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)
You likely can't join if
- 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...
- 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...
- Pregnant or breastfeeding, or expecting to conceive or father children within the projected duration of the study, starting with the pre-screening or...
- Has a known history of active tuberculosis (Bacillus Tuberculosis)
See the full eligibility criteria
Who can join
- 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)
- Hemoglobin \> 9.0 g/dL (obtained within 14 days prior to vaccine administration) (NOTE: The use of transfusion or other intervention to achieve hemoglobin [Hgb] \> 9.0g/dl is acceptable)
- Serum creatinine =\ = 60 mL/min using Cockcroft-Gault equation for patients with creatinine levels \> 1.5 x institutional ULN (obtained within 14 days prior to vaccine administration)
- Total bilirubin =\< 1.5 x ULN OR direct bilirubin =\< 1 x ULN (obtained within 14 days prior to vaccine administration)
- Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) =\< 2.5 x ULN unless liver metastases are present, in which case they must be =\< 5 x ULN (obtained within 14 days prior to vaccine administration)
- Bilirubin =\< 1.5 X ULN (except in participants with documented Gilbert's disease, who must have a total bilirubin =\< 3.0 mg/dL) (obtained within 14 days prior to vaccine administration)
- International normalized ratio (INR) or prothrombin time (PT) =\< 1.5 x ULN unless patient is receiving anticoagulant therapy as long as PT or partial thromboplastin time (PTT) is within therapeutic range of intended...
- Activated partial thromboplastin time (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 (obtained within 14 days...
- TNBC as defined by estrogen receptor (ER)/progesterone receptor (PR) =\< 10% if Allred =\< 3; Her2/neu negative as defined by scores of 0 or 1+ by immunohistochemistry (IHC) or 2+ by IHC associated with a fluorescence...
- Patients with metastatic or inoperable locally advanced disease: Metastatic or inoperable locally advanced disease is defined as either histologically confirmed metastatic breast cancer by biopsy; or locally advanced...
- Documented metastatic biopsy is not required provided the patient has a prior diagnosis of TNBC that otherwise meets the eligibility criteria
- Eligible patients must have =\ = 21 days prior to cycle (C)1 day (D)1 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...
- Prior checkpoint inhibitor is permitted. 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
- Patients who are metastatic or inoperable, locally advanced will only be eligible for the Phase 1b combination cohort. They will not be eligible for the Phase 1a dose escalation cohort. Patients who have received prior...
- Patients with early stage TNBC: Early stage TNBC is defined as clinical or pathologic Stage I-III TNBC
- After resection of disease in the breast and axilla, early stage patients are eligible for either the Phase 1a dose escalation of TMV vaccine monotherapy Cohort A or the Phase 1b combination arm of the vaccine with...
- Patients will be required to have completed adjuvant radiotherapy (if indicated) \>= 14 days prior to initiation of vaccine on trial
- Patients who have residual disease after completion neoadjuvant therapy that proceed with adjuvant capecitabine can enroll \>= 28 days after completion of final dose of capecitabine. Patients electing to enroll onto the...
- Patients who have a germline BRCA 1/2 mutation that meet the Food and Drug Administration (FDA) indication for use of adjuvant Olaparib can enroll \>= 28 days after completion of final dose of olaparib. Patients...
- Patients who undergo upfront surgery: Patients may initiate injection of vaccine \>= 28 days after completion of final cycle of adjuvant chemotherapy
- Patients who have early stage breast cancer that have residual disease after completing neoadjuvant chemotherapy with the KEYNOTE 522 regimen (pembrolizumab at a dose of 200 mg every 3 weeks plus weekly paclitaxel and...
- Patient enrolling onto Phase 1a Cohort A will initiate injection of vaccine \>= 28 days after completion of final cycle of standard of care adjuvant pembrolizumab
- Patient enrolling onto Phase 1b Cohort B or C will initiate injection of vaccine \>= 28 days surgical resection. Patients who have received pembrolizumab as part of the preoperative KEYNOTE 522 regimen will...
- Patients who have early stage breast cancer that have that have residual disease after completing neoadjuvant chemotherapy with either dose-dense doxorubicin-cyclophosphamide followed by paclitaxel or...
- Patient enrolling onto Phase 1a Cohort A will initiate injection of vaccine \>= 28 days surgical resection
- Patient enrolling onto Phase 1b Cohort B or C will initiate injection of vaccine \>= 28 days surgical resection. Patients will be assigned to receive either pembrolizumab (Cohort B) every 3 weeks for 6 cycles or...
- Weight of tumor tissue for production of vaccine must be at least 1 gram. In metastatic patients, preferentially, invasive tumor in breast or lymph node tissue will be retrieved by excisional biopsy to ensure sufficient...
- In patients with early stage TNBC undergoing upfront surgery, the tumor tissue will be retrieved during lumpectomy/mastectomy. In early stage patients who are identified as high risk of having residual disease after...
- Measurable disease is not required in metastatic patients but patients must have sufficient tumor to yield 1g on biopsy to enable production of personalized TMV vaccine product
- 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
- Able and willing to complete the entire study according to the study schedule
- Patients must give written informed consent. A copy of the signed informed consent form will be retained in the patient's chart
What rules you out
- 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...
- 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...
- Pregnant or breastfeeding, or expecting to conceive or father children within the projected duration of the study, starting with the pre-screening or screening visit through 120 days after the last dose of study...
- Has a known history of active tuberculosis (Bacillus Tuberculosis)
- History of allogeneic organ transplant
- Known active central nervous system (CNS) metastases and/or carcinomatous meningitis. Patients with previously treated brain metastases may participate provided they are stable (without evidence of progression by...
- Diagnosis of immunodeficiency or is receiving systemic steroid therapy or any other form of immunosuppressive therapy within 7 days prior to the first dose of study treatment, with the exceptions of intranasal and...
- Active autoimmune disease that has required systemic treatment in the past 2 years (i.e., with use of disease modifying agents, corticosteroids, or immunosuppressive drugs). Replacement therapy (e.g., thyroxine...
- Known history of non-infectious pneumonitis that required steroids or any evidence of active pneumonitis
- Failure to recover from grade 3 or 4 toxicity from previous treatment
- For the combination cohort: prior grade 4 immune-related adverse events due to previous ICI. Patients who experienced grade 2 or 3 toxicity with prior ICI therapy may enroll if toxicity reverted to =\< grade 1
The study team makes the final eligibility decision.
Where it's taking place
- Atlanta, Georgia, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The study runs about 2 years per participant, based on its public description. The team confirms the exact schedule and number of visits before you enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Atlanta, Georgia, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.