Personalized Cancer Vaccine (PCV) Strategy in Triple Negative Breast Cancer Patients

Part of paid clinical trials in St Louis, Missouri.

Sponsor
Washington University School of Medicine
Study ID
NCT07300475
Phase
PHASE1
Status
Not Yet Recruiting

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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Paclitaxel — DRUG
    As part of the KEYNOTE 522 Regimen, given per standard of care.
  • Carboplatin — DRUG
    As part of the KEYNOTE 522 Regimen, given per standard of care.
  • Pembrolizumab — DRUG
    As a part of the KEYNOTE 522 Regimen, given per standard of care. Adjuvant pembrolizumab will be given per standard of care.
  • Doxorubicin — DRUG
    As part of the KEYNOTE 522 Regimen, given per standard of care.
  • Cyclophosphamide — DRUG
    As part of the KEYNOTE 522 Regimen, given per standard of care.
  • Personalized cancer vaccine (PCV) — BIOLOGICAL
    PCV is given intra-muscular (IM). Each PCV 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 — DRUG
    AB248 is given intravenously (IV) over 30 minutes at the recommended dose.
  • pVAC tools neoantigen prediction algorithm — OTHER
    The pVACtools suite of software tools will be used to identify and prioritize cancer neoantigens based on neoantigen identification algorithms.
  • poly-ICLC — DRUG
    Poly-ICLC is mixed with the personalized cancer vaccine (PCV). The PCV is given intramuscularly (IM) at 1mg dose.

Study Details

This is a phase 1 clinical trial to evaluate the safety, feasibility and immunogenicity of a personalized cancer vaccine (PCV) strategy with or without CD8-selective IL-2 mutein fusion protein in patients with triple negative breast cancer undergoing neoadjuvant chemoimmunotherapy.

Key Dates

Start date
Aug 1, 2026
Status verified
Jun 2026
Primary completion
May 31, 2030
Completion
Apr 30, 2035

Study Design

Enrollment
30 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Arm 1: Neoadjuvant SOC KEYNOTE 522 + Adjuvant PCV + Pembrolizumab
    Patients will be treated with standard of care (SOC) neoadjuvant chemoimmunotherapy according to the KEYNOTE 522 regimen. Approximately 2 weeks after the conclusion of SOC neoadjuvant therapy but prior to SOC surgery, patients will start the personalized cancer vaccine (PCV). Patients will receive 5 doses of the PCV + 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 PCV + poly-ICLC on days 43, 64, and 85 along with SOC adjuvant pembrolizumab.
  • Experimental: Arm 2: Neoadjuvant SOC KEYNOTE 522 + Adjuvant PCV + Pembrolizumab+AB248
    Patients will be treated with standard of care (SOC) neoadjuvant chemoimmunotherapy according to the KEYNOTE 522 regimen. Approximately 2 weeks after the conclusion of SOC neoadjuvant therapy but prior to SOC surgery, patients will start the personalized cancer vaccine (PCV). Patients will receive 5 doses of the PCV + poly-ICLC on Days 1, 4, 8, 15, and 22. Patients will also receive 2 doses of AB248. Patients will undergo the SOC surgery on Day 29 +/- 5 days. Following surgery, patients will receive 3 additional doses of the PCV + poly-ICLC on days 43, 64, and 85 along with SOC adjuvant pembrolizumab.

Primary Outcome Measure

Treatment-emergent adverse events (TEAEs) [ Time Frame: Step 1 enrollment to 30 days after completion of PCV treatment (estimated time of 115 days) ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Washington University School of MedicineSt LouisMissouri63110
William Gillanders, MD
[email protected]
314-747-0072
Katherine Clifton, M.D.
[email protected]
314-273-3712
William Gillanders, MD (PRINCIPAL_INVESTIGATOR)
Katherine Clifton, MD (PRINCIPAL_INVESTIGATOR)
Malachi Griffith, PhD (SUB_INVESTIGATOR)
Obi Griffith, PhD (SUB_INVESTIGATOR)
Cynthia Ma, MD, PhD (SUB_INVESTIGATOR)
Robert Schreiber, PhD (SUB_INVESTIGATOR)
Feng Gao, MD, PhD, MPH (SUB_INVESTIGATOR)
Peter Goedegebuure, PhD (SUB_INVESTIGATOR)
Lijin Li, PhD (SUB_INVESTIGATOR)
Sherri Davies, PhD (SUB_INVESTIGATOR)
Ian Hagemann, MD, PhD (SUB_INVESTIGATOR)

Find similar trials in St Louis, MO

By condition
Breast cancer
By specialty
OncologyBreast oncologyWomen's health
By research site
Washington University School of Medicine· St Louis, MO

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