Personalized Cancer Vaccine for Triple Negative Breast Cancer
This study is testing a personalized cancer vaccine (PCV) in people with newly diagnosed, locally advanced triple negative breast cancer. You would also receive standard treatments like Paclitaxel, Carboplatin, Pembrolizumab, Doxorubicin, and Cyclophosphamide. The main goal is to see how safe the PCV is and if it causes any side effects. This is a Phase 1 study, meaning it's an early step to check safety. The study aims to enroll 30 participants. The current recruitment status is unclear.
- Study design
- This is a Phase 1 interventional study, meaning participants will receive specific treatments. It aims to enroll 30 participants.
- What's involved
- The study will track side effects from when you enroll until 30 days after completing the personalized cancer vaccine treatment, which is estimated to be 115 days.
- Compensation
- Not stated in the trial record.
- Follow-up
- Side effects will be tracked for 30 days after the personalized cancer vaccine treatment is completed.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
NCT07300475
Personalized Cancer Vaccine (PCV) Strategy in Triple Negative Breast Cancer Patients
Not Yet Recruiting
PHASE1Ages 18+InterventionalTreatmentWashington University School of MedicineInvestigator-initiated
~30 participants
Updated 2026-06-15 on ClinicalTrials.gov
What's tested:PaclitaxelCarboplatinPembrolizumabDoxorubicinCyclophosphamidePersonalized cancer vaccine (PCV)
At a glance
Recruiting sites
0 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Treatment-emergent adverse events (TEAEs)
Measured over Step 1 enrollment to 30 days after completion of PCV treatment (estimated time of 115 days)
+5 more outcomes measured
Conditions
Where it's being run
1 sites across 1 statesMissouri1
Study leadership
- William Gillanders, MD · PRINCIPAL_INVESTIGATOR · Washington University School of Medicine
Who to contact
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Do you actually qualify for this trial?
Add a private profile and we'll compare every criterion below against your situation — and tell you which ones are met, uncertain, or excluding.
Eligibility criteria
Inclusion
Newly diagnosed, previously untreated, locally advanced non-metastatic triple negative breast cancer (as defined by the most recent ASCO/CAP guidelines). Permissible staging per AJCC is as follows:
T1c, N1-N2
T2, N0-N2
T3, N0-N2
At least 18 years of age.
Adequate tissue available for nucleic acid isolation/PCV design or willing to undergo biopsy if adequate tissue is not available.
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). Note that patients who are already receiving the KEYNOTE 522 regimen at the time of screening must have adequate archival tissue for nucleic acid isolation/PCV design (biopsy will not be permitted).
TIL percentage \< 10% (performed on SOC biopsy).
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 PCV
Adequate bone marrow and organ function within 28 days of initiation of PCV 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 PCV 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 PCV. 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
Prior or concurrent malignancy whose natural history has the potential to interfere with the safety or efficacy assessment of the investigational regimen. Patients with prior or concurrent malignancy that does NOT meet that definition are eligible for this trial.
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. Patients may be permitted to enroll with a grade 3 AE with approval of the PI and treating physician.
QTcF \> 470 msec.
What this trial measures
- Treatment-emergent adverse events (TEAEs)Step 1 enrollment to 30 days after completion of PCV treatment (estimated time of 115 days)
Treatment-emergent adverse events (TEAEs) will be assessed via CTCAE v6.
- Treatment-related adverse events (TRAEs)Step 1 enrollment to 30 days after completion of PCV treatment (estimated time of 115 days)
Treatment-related adverse events (TRAEs) will be assessed via CTCAE v6.
- Serious adverse events (SAEs)Step 1 enrollment to 30 days after completion of PCV treatment (estimated time of 115 days)
Serious adverse events (SAEs) will be assessed via CTCAE v6.
- Feasibility as determined by number of enrolled patients with triple negative breast cancerCompletion of enrollment (1 day for patient)
Defined as enrolling 24 evaluable patients in 36 months.
- Feasibility as determined by time required for PCV design and manufactureStart of Step 0 Enrollment to PCV completion (estimated time of 24 weeks)
Defined as completion of design and manufacture within 24 weeks.
- Feasibility as determined by rate of successful PCV deliveryDay 1
Defined as at least 70% of patients receiving at least one dose of PCV.