Dendritic Cell Immunotherapy for Triple Negative Breast Cancer

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Roswell Park Cancer Institute

Must not be taking: Immunosuppressants, Steroids

Disqualifiers: Autoimmune disease, CNS metastases, others

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

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 4

Duration: 12 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This phase II trial tests the safety, side effects, and whether dendritic cell-based treatment and pembrolizumab work in treating patients with triple negative breast cancer that has spread to other places in the body (metastatic) or cannot be removed by surgery (unresectable). The term triple-negative breast cancer refers to the fact that the cancer cells don't have estrogen or progesterone receptors (ER or PR) and also don't make any or too much of the protein called HER2 (the cells test "negative" on all 3 tests). Dendritic cell-based treatment works by boosting the immune system (a system in our bodies that protects us against infection) to recognize and destroy the cancer cells. Pembrolizumab, is an immune checkpoint inhibitor drug, that works by targeting molecules that act as a check and balance system for immune responses. Immune checkpoint inhibitor drugs are designed to either "unleash" or "enhance" the cancer immune responses that already exist by either blocking inhibitory molecules or by activating stimulatory molecules. Giving dendritic cell-based therapy and pembrolizumab may decrease symptoms and improve quality of life in patients with triple negative breast cancer.

Who Is on the Research Team?

Shipra Gandhi

Principal Investigator

Roswell Park Cancer Institute

Are You a Good Fit for This Trial?

This trial is for adults with triple negative breast cancer that has spread or can't be surgically removed. Participants need at least two target lesions, normal liver and blood function, and must use birth control if of child-bearing potential. Exclusions include active infections, certain heart conditions, immunodeficiency disorders, recent vaccine administration, and brain metastases.

Inclusion Criteria

I have at least 2 tumors that can be measured and one can be biopsied.

Your AST and ALT levels in your blood are not too high. If you have liver metastases, your ALT levels should not be more than five times the normal limit.

Participant must understand the investigational nature of this study and sign an Independent Ethics Committee/Institutional Review Board approved written informed consent form prior to receiving any study related procedure

Exclusion Criteria

I have an immune system disorder or have been on high-dose steroids or other immune-weakening medicines recently.

I had radiotherapy over 2 weeks ago, recovered from side effects, and didn't have lung inflammation from it.

I haven't taken strong immune system suppressants or high-dose steroids in the last 3 weeks.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Leukapheresis

Patients undergo leukapheresis over 90 minutes to collect cells for dendritic cell preparation

1 day

1 visit (in-person)

Treatment

Patients receive ST-alpha-DC1 intratumorally on days 1, 8, and 50 and pembrolizumab intravenously on days 8, 29, 50, and 71

12 weeks

Multiple visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

2 years

Follow-up visits every 3 months

What Are the Treatments Tested in This Trial?

Interventions

• Alpha-type-1 Polarized Dendritic Cells
• Pembrolizumab

Trial Overview The trial tests a combination of dendritic cell-based treatment to boost the immune system's ability to fight cancer cells and pembrolizumab—an immune checkpoint inhibitor—to potentially enhance this effect. The goal is to see if these treatments together can reduce symptoms and improve life quality in patients.

How Is the Trial Designed?

Group I: Treatment (ST-alpha-DC1, pembrolizumab) Experimental Treatment 6 Interventions

Patients undergo leukapheresis over 90 minutes. Patients then receive ST-alpha-DC1 IT on days 1, 8, and 50 in the absence of disease progression or unacceptable toxicity. Patients also receive pembrolizumab IV on days 8, 29, 50, and 71 in the absence of disease progression or unacceptable toxicity. Patients who are receiving clinical benefit from treatment at the end of day 85, may continue to receive pembrolizumab IV every 3 weeks beyond the 4 study doses. Patients also undergo tumor biopsies on days 1, 8, and 50 and CT scans at baseline and days 50 and 85.

Who Is Running the Clinical Trial?

Roswell Park Cancer Institute

Lead Sponsor

Trials

427

Recruited

40,500+