Cancer Immunotherapeutic (PCI) Strategy in Triple Negative Breast Cancer Patients
NCT ID: NCT07300475
Last Updated: 2025-12-23
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
PHASE1
30 participants
INTERVENTIONAL
2026-03-31
2034-12-09
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Arm 1: Neoadjuvant SOC KEYNOTE 522 + Adjuvant PCI + Pembrolizumab
Patients will be treated with standard of care (SOC) neoadjuvant chemoimmunotherapy according to the KEYNOTE 522 regimen for eight 21-day cycles. Patients will take a 2-week drug holiday from the end of SOC neoadjuvant chemoimmunotherapy to the start of personalized cancer immunotherapeutic (PCI). Patients will receive 5 doses of the PCI + poly-ICLC on Days 1, 4, 8, 15, and 22. Patients will undergo the SOC surgery on Day 29 +/- 5 days. Following surgery, patients will receive 3 additional doses of the PCI + poly-ICLC. Patients will receive 9 doses of SOC adjuvant pembrolizumab on a 21-day cycle. The PCI + poly-ICLC will be given on Days 43, 64, and 85.
Paclitaxel
As part of the KEYNOTE 522 Regimen, paclitaxel is given intravenously (IV) with a dose 80 mg/m2 on Days 1, 8, and 15 of a 21 day cycle after Step 0 enrollment. Paclitaxel will be given a total of 4 cycles (cycles 1-4).
Carboplatin
As part of the KEYNOTE 522 Regimen, carboplatin is given intravenously (IV) with a dose of AUC 1.5 on Days 1, 8, and 15 of a 21 day cycle after Step 0 enrollment. Carboplatin will be given a total of 4 cycles (cycles 1-4).
Pembrolizumab
As a part of the KEYNOTE 522 Regimen, pembrolizumab is given intravenously (IV) at a dose of 200 mg on Day 1 of a 21 day cycle after Step 0 enrollment. Pembrolizumab will be given for 8 cycles (cycles 1-8)
Pembrolizumab will also be given intravenously (IV) at a dose of 200 mg on days 43, 64, and 85 (same as adjuvant PCI) and then 6 additional doses.
Doxorubicin
As part of the KEYNOTE 522 Regimen, doxorubicin will be given intravenously (IV) at a dose of 60 mg/m2 on Day 1 of a 21 day cycle after Step 0 enrollment. Doxorubicin will be given a total of 4 cycles (cycles 5-8).
Cyclophosphamide
As part of the KEYNOTE 522 Regimen, cyclophosphamide is given intravenously (IV) at a dose of 600 mg/m2 dose on Day 1 of a 21 day cycle after Step 0 enrollment. Cyclophosphamide will be given a total of 4 cycles (cycles 5-8).
Personalized cancer immunotherapeutic (PCI)
PCI is given intra-muscular (IM) at 1 mg dose. Each PCI will consists of up to 4 separate injections, with each syringe containing peptides from one of the up to four peptide pools combined with adjuvant poly-ICLC.
pVAC tools neoantigen prediction algorithm
The pVACtools suite of software tools will be used to identify and prioritize cancer neoantigens based on neoantigen identification algorithms.
poly-ICLC
Poly-ICLC is mixed with the personalized cancer immunotherapeutic (PCI). The PCI is given intramuscularly (IM) at 1mg dose.
Arm 2: Neoadjuvant SOC KEYNOTE 522 + Adjuvant PCI + Pembrolizumab+AB248
Patients will be treated with standard of care (SOC) neoadjuvant chemoimmunotherapy according to the KEYNOTE 522 regimen for eight 21-day cycles. Patients will take a 2-week drug holiday from the end of SOC neoadjuvant chemoimmunotherapy to the start of personalized cancer immunotherapeutic (PCI). Patients will receive 5 doses of the PCI + poly-ICLC on Days 1, 4, 8, 15, and 22. Patients will also receive 2 doses of AB248 on Days 8 and 22. Patients will undergo the SOC surgery on Day 29 +/- 5 days. Following surgery, patients will receive 3 additional doses of the PCI + poly-ICLC. Patients will receive 9 doses of SOC adjuvant pembrolizumab on a 21-day cycle. The PCI + poly-ICLC will be given on Days 43, 64, and 85.
Paclitaxel
As part of the KEYNOTE 522 Regimen, paclitaxel is given intravenously (IV) with a dose 80 mg/m2 on Days 1, 8, and 15 of a 21 day cycle after Step 0 enrollment. Paclitaxel will be given a total of 4 cycles (cycles 1-4).
Carboplatin
As part of the KEYNOTE 522 Regimen, carboplatin is given intravenously (IV) with a dose of AUC 1.5 on Days 1, 8, and 15 of a 21 day cycle after Step 0 enrollment. Carboplatin will be given a total of 4 cycles (cycles 1-4).
Pembrolizumab
As a part of the KEYNOTE 522 Regimen, pembrolizumab is given intravenously (IV) at a dose of 200 mg on Day 1 of a 21 day cycle after Step 0 enrollment. Pembrolizumab will be given for 8 cycles (cycles 1-8)
Pembrolizumab will also be given intravenously (IV) at a dose of 200 mg on days 43, 64, and 85 (same as adjuvant PCI) and then 6 additional doses.
Doxorubicin
As part of the KEYNOTE 522 Regimen, doxorubicin will be given intravenously (IV) at a dose of 60 mg/m2 on Day 1 of a 21 day cycle after Step 0 enrollment. Doxorubicin will be given a total of 4 cycles (cycles 5-8).
Cyclophosphamide
As part of the KEYNOTE 522 Regimen, cyclophosphamide is given intravenously (IV) at a dose of 600 mg/m2 dose on Day 1 of a 21 day cycle after Step 0 enrollment. Cyclophosphamide will be given a total of 4 cycles (cycles 5-8).
Personalized cancer immunotherapeutic (PCI)
PCI is given intra-muscular (IM) at 1 mg dose. Each PCI will consists of up to 4 separate injections, with each syringe containing peptides from one of the up to four peptide pools combined with adjuvant poly-ICLC.
AB248 (CD8-selective IL-2 mutein fusion protein)
AB248 is given intravenously (IV) over 30 minutes in 0.15 mg/kg dose. AB248 is given on Days 8 and 22 after Step 1 enrollment.
pVAC tools neoantigen prediction algorithm
The pVACtools suite of software tools will be used to identify and prioritize cancer neoantigens based on neoantigen identification algorithms.
poly-ICLC
Poly-ICLC is mixed with the personalized cancer immunotherapeutic (PCI). The PCI is given intramuscularly (IM) at 1mg dose.
Interventions
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Paclitaxel
As part of the KEYNOTE 522 Regimen, paclitaxel is given intravenously (IV) with a dose 80 mg/m2 on Days 1, 8, and 15 of a 21 day cycle after Step 0 enrollment. Paclitaxel will be given a total of 4 cycles (cycles 1-4).
Carboplatin
As part of the KEYNOTE 522 Regimen, carboplatin is given intravenously (IV) with a dose of AUC 1.5 on Days 1, 8, and 15 of a 21 day cycle after Step 0 enrollment. Carboplatin will be given a total of 4 cycles (cycles 1-4).
Pembrolizumab
As a part of the KEYNOTE 522 Regimen, pembrolizumab is given intravenously (IV) at a dose of 200 mg on Day 1 of a 21 day cycle after Step 0 enrollment. Pembrolizumab will be given for 8 cycles (cycles 1-8)
Pembrolizumab will also be given intravenously (IV) at a dose of 200 mg on days 43, 64, and 85 (same as adjuvant PCI) and then 6 additional doses.
Doxorubicin
As part of the KEYNOTE 522 Regimen, doxorubicin will be given intravenously (IV) at a dose of 60 mg/m2 on Day 1 of a 21 day cycle after Step 0 enrollment. Doxorubicin will be given a total of 4 cycles (cycles 5-8).
Cyclophosphamide
As part of the KEYNOTE 522 Regimen, cyclophosphamide is given intravenously (IV) at a dose of 600 mg/m2 dose on Day 1 of a 21 day cycle after Step 0 enrollment. Cyclophosphamide will be given a total of 4 cycles (cycles 5-8).
Personalized cancer immunotherapeutic (PCI)
PCI is given intra-muscular (IM) at 1 mg dose. Each PCI will consists of up to 4 separate injections, with each syringe containing peptides from one of the up to four peptide pools combined with adjuvant poly-ICLC.
AB248 (CD8-selective IL-2 mutein fusion protein)
AB248 is given intravenously (IV) over 30 minutes in 0.15 mg/kg dose. AB248 is given on Days 8 and 22 after Step 1 enrollment.
pVAC tools neoantigen prediction algorithm
The pVACtools suite of software tools will be used to identify and prioritize cancer neoantigens based on neoantigen identification algorithms.
poly-ICLC
Poly-ICLC is mixed with the personalized cancer immunotherapeutic (PCI). The PCI is given intramuscularly (IM) at 1mg dose.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* T1c, N1-N2
* T2, N0-N2
* T3, N0-N2
* At least 18 years of age.
* Adequate tissue available for nucleic acid isolation/PCI design.
* Adequate cardiac function per treating physician and a candidate for the KEYNOTE 522 regimen (or receiving the KEYNOTE 522 regimen for no more than one month).
* Ability to understand and willingness to sign an IRB approved written informed consent document. Legally authorized representatives may sign and give informed consent on behalf of study participants.
* ECOG performance status ≤ 1 within 10 days of initiation of PCI
* Adequate bone marrow and organ function as defined below:
* Absolute neutrophil count ≥ 1.0 K/cumm
* Platelets ≥ 100 K/cumm
* Hemoglobin ≥ 8.0 g/dL
* Total bilirubin ≤ 1.5 x IULN
* AST(SGOT)/ALT(SGPT) ≤ 3.0 x IULN
* Creatinine clearance \> 30 mL/min by Cockcroft-Gault
* The effects of the PCI on the developing human fetus are unknown. For this reason, women of childbearing potential and men must agree to use adequate contraception prior to study entry, for the duration of study participation, and for 6 months after last dose of PCI. Should a woman become pregnant or suspect she is pregnant while participating in this study or should a man suspect he has fathered a child, s/he must inform her treating physician immediately.
* Received at least 4 months of the KEYNOTE 522 regimen.
Exclusion Criteria
* Received prior chemotherapy, targeted therapy, or radiation therapy within the past 12 months.
* Received prior therapy with an anti-PD-1, anti-PD-L1, or anti-PD-L2 agent, or with an agent directed to another co-inhibitory T-cell receptor.
* Currently receiving any other investigational agents.
* A history of allergic reactions attributed to compounds of similar chemical or biologic composition to any agents used in the study.
* Received a live vaccine within 30 days of the first dose of pembrolizumab.
* Active autoimmune disease that has required systemic treatment in the past 2 years.
* Diagnosis of immunodeficiency or receiving systemic steroid therapy or any other form of immunosuppressive therapy within 7 days prior to the first dose of pembrolizumab.
* History of (non-infectious) pneumonitis that required steroids, or current pneumonitis.
* Uncontrolled intercurrent illness including, but not limited to: ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, or cardiac arrhythmia. Patients with a known history or current symptoms of cardiac disease, or history of treatment with cardiotoxic agents, should have a clinical risk assessment of cardiac function using the New York Heart Association Function Classification; to be eligible for this trial, patients should be a class 2B or better.
* Pregnant and/or breastfeeding. Women of childbearing potential must have a negative pregnancy test within 7 days of study entry.
* Known history of active TB (bacillus tuberculosis).
* Known history of HIV.
* Evidence of chronic hepatitis B virus (HBV) that is detectable on suppressive therapy. Patients with evidence of chronic HBV infection with undetectable HBV viral load on suppressive therapy are eligible. HBV testing not required in the absence of known history of infection.
* History of hepatitis C virus (HCV) infection that has not been cured or that has a detectable viral load. Patients with a history of HCV that has been treated and cured are eligible. Patients with HCV infection who are currently on treatment and have an undetectable HCV viral load are eligible. HCV testing not required in the absence of known history of infection.
* Currently receiving any other investigational agents.
* Pregnant and/or breastfeeding.
* Experiencing ongoing AEs related to the SOC KEYNOTE 522 regimen that have not resolved to \< grade 3.
18 Years
ALL
No
Sponsors
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Washington University School of Medicine
OTHER
Responsible Party
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Principal Investigators
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William Gillanders, MD
Role: PRINCIPAL_INVESTIGATOR
Washington University School of Medicine
Locations
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Washington University School of Medicine
St Louis, Missouri, United States
Countries
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Central Contacts
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Facility Contacts
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William Gillanders, MD
Role: primary
Katherine Clifton, M.D.
Role: backup
Related Links
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Alvin J. Siteman Cancer Center at Barnes-Jewish Hospital and Washington University School of Medicine
Other Identifiers
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25-x465
Identifier Type: -
Identifier Source: org_study_id