Cancer Immunotherapeutic (PCI) 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, 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 — DRUG
    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 — DRUG
    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 — DRUG
    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 — DRUG
    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) — BIOLOGICAL
    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) — 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 immunotherapeutic (PCI). The PCI 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 immunotherapeutic (PCI) 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
Jun 30, 2026
Status verified
May 2026
Primary completion
Apr 8, 2030
Completion
Mar 9, 2035

Study Design

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

Arms

  • Experimental: 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.
  • Experimental: 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. 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.

Primary Outcome Measure

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

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Washington University School of MedicineSt LouisMissouri63110
William Gillanders, MD
[email protected]
3147470072
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)

Find similar trials in St Louis, MO

By condition
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By specialty
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By research site
Washington University School of Medicine· St Louis, MO

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