Actively Recruiting
Dendritic Cell Vaccines Against Her2/Her3 and Pembrolizumab for Brain Metastases from Triple Negative or HER2+ Breast Cancer
Led by Roswell Park Cancer Institute ยท Updated on 2026-05-11
23
Participants Needed
3
Research Sites
26 weeks
Total Duration
On this page
Sponsors
R
Roswell Park Cancer Institute
Lead Sponsor
U
United States Department of Defense
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating dendritic cell vaccines targeting Her2/Her3 combined with pembrolizumab for treating women with triple negative breast cancer, HER2+ breast cancer, or hormone receptor positive breast cancer that has spread to the brain. This phase IIa trial aims to understand how well this combination works in shrinking brain metastases and improving survival while monitoring safety. The vaccines boost the immune system to fight cancer cells, and pembrolizumab is designed to enhance immune responses against cancer. During the treatment phase, participants receive the anti-HER2/HER3 dendritic cell vaccine injected into the skin on days 1, 22, and 43, alongside pembrolizumab given intravenously on the same days. In the maintenance phase, pembrolizumab infusions are given every 21 days for up to 2 years if the disease does not progress or cause unacceptable side effects. Booster doses of the vaccine may also be given every 3 to 6 months based on the investigator's decision. Participants will undergo brain scans to measure tumor changes, blood tests, and pregnancy tests as needed. Researchers will assess brain tumor response, progression-free survival in the brain and body, overall survival, and treatment safety for up to 2 years. The study also tracks the need for retreatment of brain metastases and evaluates the stability of previously irradiated brain lesions. Participants' health and response to treatment will be closely monitored throughout the study period.
CONDITIONS
Brief Title
Dendritic Cell Vaccines Against Her2/Her3 and Pembrolizumab for the Treatment of Brain Metastasis From Triple Negative Breast Cancer or HER2+ Breast Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Female participant who is not pregnant or breastfeeding
- Women of childbearing potential must agree to use effective birth control during the study and for at least two years after
- Negative pregnancy tests at screening and before leukapheresis, and as needed during treatment
- Confirmed diagnosis of triple negative breast cancer, HER2+ breast cancer, or hormone receptor positive breast cancer
- Measurable brain metastases meeting size criteria, asymptomatic and not requiring local therapy
- Prior radiotherapy allowed if completed at least 2 weeks before vaccine treatment and lesions meet criteria
- ECOG performance status of 0 or 1
- Adequate organ and marrow function based on blood tests within 10 days before treatment
- Life expectancy greater than 3 months
- Prior checkpoint inhibitors allowed if at least 3 weeks before enrollment
- Stable systemic disease or manageable progression under specified treatments
You will not qualify if you...
- Any condition interfering with study participation or results
- Symptomatic brain metastases not resolved with local therapy
- Participation in other investigational studies within 4 weeks before treatment
- Recent chemotherapy or targeted therapy within 4 weeks before treatment
- Rapidly progressing systemic disease
- Active autoimmune diseases requiring systemic treatment in past 2 years
- History of organ transplantation
- Active infections requiring systemic therapy
- Known active hepatitis B or C or immunosuppressive diseases
- Blood transfusion within 2 weeks before leukapheresis
- Pregnant or actively nursing females unwilling to stop nursing
- Unable or unwilling to follow study protocol
- Brain lesions causing significant midline shift or hydrocephalus
- High dose corticosteroid use above 10 mg prednisone equivalent daily
- Recent stroke or transient ischemic attack within 6 months
- History or current pneumonitis or interstitial lung disease requiring steroids
- Presence of leptomeningeal disease
- Contraindications to MRI
- Recent radiotherapy within 2 weeks before treatment
- Recent live vaccine within 30 days before treatment
- Immunodeficiency or recent immunosuppressive therapy
- Active malignancy requiring treatment within past 3 years except certain skin or in situ cancers
- Positive pregnancy test within 72 hours before leukapheresis
- Known carcinomatous meningitis
- Psychiatric or substance abuse disorders interfering with study participation
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Approximately 6 weeks
Participants receive anti-HER2/HER3 dendritic cell vaccine intradermally and pembrolizumab intravenously on days 1, 22, and 43.
3 visits (in-person) on days 1, 22, and 43
Duration - Up to 2 years
Participants receive pembrolizumab intravenously every 21 days for up to 2 years, with possible booster doses of anti-HER2/HER3 vaccine every 3 to 6 months as determined by the principal investigator.
Visits every 3 weeks for pembrolizumab infusion; booster vaccine visits every 3 to 6 months as needed
Trial Site Locations
Total: 3 locations
1
Moffitt Cancer Center
Tampa, Florida, United States, 33612
Active, Not Recruiting
2
Roswell Park Cancer Institute
Buffalo, New York, United States, 14263
Actively Recruiting
3
University of Virginia Comprehensive Cancer Center
Charlottesville, Virginia, United States, 22903
Actively Recruiting
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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