← Back to Search

Cancer Vaccine

Dendritic Cell Immunotherapy for Triple Negative Breast Cancer

Phase 2
Waitlist Available
Led By Shipra Gandhi
Research Sponsored by Roswell Park Cancer Institute
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
At least 2 target lesions present per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 at least one of which is amenable to biopsy and injection
Age >= 18 years of age
Must not have
Has a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy (in dosing exceeding 10 mg daily of prednisone equivalent) or any other form of immunosuppressive therapy within 7 days prior to the first dose of study drug
Participants currently treated with systemic immunosuppressive agents, including steroids (> than equivalent of 10 mg daily of prednisone) are ineligible until 3 weeks after removal from immunosuppressive treatment
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 2 years
Awards & highlights

Summary

This trial is testing a new cancer treatment for patients with triple negative breast cancer that has spread or can't be removed by surgery. The treatment boosts the immune system to recognize and destroy cancer cells.

Who is the study for?
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.
What is being tested?
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.
What are the potential side effects?
Possible side effects may include reactions related to the immune system such as flu-like symptoms, fatigue, skin reactions; organ inflammation; increased risk of infection; allergic responses to pembrolizumab components; plus any discomfort from procedures like leukapheresis (white blood cell removal) or biopsies.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I have at least 2 tumors that can be measured and one can be biopsied.
Select...
I am 18 years old or older.
Select...
My breast cancer cannot be surgically removed, has spread, and cannot be cured.
Select...
I have PD-L1 negative triple-negative breast cancer and haven't received first-line treatment for its metastatic stage.
Select...
I can take care of myself and am up and about more than half of my waking hours.
Select...
My kidney function, measured by creatinine levels, is within the normal range or slightly above.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
Select...
I have an immune system disorder or have been on high-dose steroids or other immune-weakening medicines recently.
Select...
I haven't taken strong immune system suppressants or high-dose steroids in the last 3 weeks.
Select...
I am currently being treated for an infection.
Select...
I have an active HIV infection.
Select...
I have or had lung inflammation that needed steroids.
Select...
I have not had a heart attack or severe heart issue in the last 3 months.
Select...
My heart condition severely limits my daily activities.
Select...
I have not received a live vaccine within the last 30 days.
Select...
I do not have any severe illnesses or social situations that would stop me from following the study's requirements.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 2 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 2 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Incidence of adverse events
Heart rate
Secondary study objectives
Objective response rate
Overall survival (OS)
Progression-free survival (PFS)
Other study objectives
Dentatorubral-Pallidoluysian Atrophy
Quality of Life as measured by the Perceived Stress Scale

Side effects data

From 2024 Phase 2 trial • 57 Patients • NCT03004183
21%
Fatigue
13%
Nausea
11%
Back pain
9%
Diarrhea
9%
Anemia
9%
Shortness of Breath
9%
Abdominal pain
7%
Kidney Injury and/or Infection
7%
Pneumonia
7%
Weight Loss
7%
Dyspnea
5%
Malnutrition, Hypercalcemia and Weakness
5%
Pneumothorax
5%
Intractable pain, back pain, hip pain
5%
Activated partial thromboplastin time prolonged
4%
Atrial fibrillation with rapid ventricular response
4%
Pleural effusion
2%
colitis
2%
Thrombocytopenia
2%
Respiratory failure
2%
Skin rash
100%
80%
60%
40%
20%
0%
Study treatment Arm
Single Arm

Trial Design

1Treatment groups
Experimental Treatment
Group I: Treatment (ST-alpha-DC1, pembrolizumab)Experimental Treatment6 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.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Biopsy
2014
Completed Phase 4
~1090
Computed Tomography
2017
Completed Phase 2
~2740
Leukapheresis
2016
Completed Phase 2
~700
Pembrolizumab
2017
Completed Phase 2
~2070

Find a Location

Who is running the clinical trial?

Roswell Park Cancer InstituteLead Sponsor
408 Previous Clinical Trials
32,399 Total Patients Enrolled
10 Trials studying Breast Cancer
1,638 Patients Enrolled for Breast Cancer
Shipra GandhiPrincipal InvestigatorRoswell Park Cancer Institute
4 Previous Clinical Trials
69 Total Patients Enrolled

Media Library

Alpha-type-1 Polarized Dendritic Cells (Cancer Vaccine) Clinical Trial Eligibility Overview. Trial Name: NCT05539365 — Phase 2
Breast Cancer Research Study Groups: Treatment (ST-alpha-DC1, pembrolizumab)
Breast Cancer Clinical Trial 2023: Alpha-type-1 Polarized Dendritic Cells Highlights & Side Effects. Trial Name: NCT05539365 — Phase 2
Alpha-type-1 Polarized Dendritic Cells (Cancer Vaccine) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05539365 — Phase 2
~13 spots leftby Oct 2026
Unbiased ResultsWe believe in providing patients with all the options.
Your Data Stays Your DataWe only share your information with the clinical trials you're trying to access.
Verified Trials OnlyAll of our trials are run by licensed doctors, researchers, and healthcare companies.
Back to top