Personalized Immunotherapy for Breast Cancer

Overseen By Katherine Clifton, M.D.

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: Washington University School of Medicine

Must be taking: KEYNOTE 522

Must not be taking: Anti-PD-1, Anti-PD-L1

Disqualifiers: Pregnancy, Autoimmune disease, Immunodeficiency, others

Stay on Your Current Meds You can continue your current medications while participating

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 17

What You Need to Know Before You Apply

What is the purpose of this trial?

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.

Who Is on the Research Team?

William Gillanders, MD

Principal Investigator

Washington University School of Medicine

Are You a Good Fit for This Trial?

This trial is for individuals with triple negative breast cancer. Participants must be suitable for neoadjuvant chemoimmunotherapy, which means they'll receive treatment before surgery to shrink the tumor. Specific eligibility details are not provided but typically include factors like age, health status, and cancer stage.

Inclusion Criteria

The effects of the PCI on the developing human fetus are unknown. Women of childbearing potential and men must agree to use adequate contraception

I have completed at least 4 months of the KEYNOTE 522 treatment.

I have enough tissue available for genetic testing.

Exclusion Criteria

I don't have another cancer that could affect this treatment's safety or results.

I am still experiencing side effects from my KEYNOTE 522 treatment.

I have not received a live vaccine within 30 days before starting pembrolizumab.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Neoadjuvant Chemoimmunotherapy

Patients receive standard of care neoadjuvant chemoimmunotherapy according to the KEYNOTE 522 regimen for eight 21-day cycles

24 weeks

8 cycles (in-person)

Personalized Cancer Immunotherapeutic (PCI) Treatment

Patients receive PCI + poly-ICLC and AB248, followed by surgery and additional PCI doses

12 weeks

Multiple visits for PCI doses and surgery

Adjuvant Pembrolizumab Treatment

Patients receive 9 doses of SOC adjuvant pembrolizumab on a 21-day cycle

27 weeks

9 cycles (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

5 years and 85 days

What Are the Treatments Tested in This Trial?

Interventions

• PCI

Trial Overview

The study tests a personalized cancer immunotherapeutic (PCI) strategy in combination with various drugs including chemotherapy agents (Cyclophosphamide, Paclitaxel, Carboplatin, Doxorubicin) and immunotherapy agents (Pembrolizumab), plus an experimental CD8-selective IL-2 mutein fusion protein called AB248.

How Is the Trial Designed?

Group I: Arm 2: Neoadjuvant SOC KEYNOTE 522 + Adjuvant PCI + Pembrolizumab+AB248 Experimental Treatment 9 Interventions

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.

Group II: Arm 1: Neoadjuvant SOC KEYNOTE 522 + Adjuvant PCI + Pembrolizumab Experimental Treatment 8 Interventions

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.

Who Is Running the Clinical Trial?

Washington University School of Medicine

Lead Sponsor

Trials

2,027

Recruited

2,353,000+