Actively Recruiting
Dendritic Cell Vaccines Against Her2/Her3 and Pembrolizumab for the Treatment of Brain Metastasis From Triple Negative Breast Cancer or HER2+ Breast Cancer
Led by Roswell Park Cancer Institute · Updated on 2026-05-11
23
Participants Needed
3
Research Sites
260 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
This phase IIa trial studies how well dendritic cell vaccines against Her2/Her3 and pembrolizumab work for the treatment of triple negative breast cancer or HER2+ breast cancer or HER+ Breast cancer that has spread to the brain (brain metastasis). Dendritic cell vaccines work by boosting the immune system (a system in the body that protect against infection) to recognize and destroy the cancer cells. . Pembrolizumab is an "immune checkpoint inhibitor" which is 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 vaccines and pembrolizumab may shrink the cancer.
CONDITIONS
Official 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 and is either not a woman of childbearing potential or agrees to follow contraceptive guidance
- Women of childbearing potential must agree to use acceptable birth control methods during the study and for several years after
- Negative serum and urine pregnancy tests at screening, before leukapheresis, prior to each pembrolizumab cycle, at end of treatment, and if pregnancy is suspected
- Histologically or cytologically confirmed diagnosis of triple negative breast cancer (TNBC), HER2+ breast cancer, or hormone receptor positive breast cancer
- Measurable asymptomatic brain metastases between 0.5 cm and less than 3.0 cm in size meeting specific MRI criteria
- Prior local therapy for brain metastases larger than or equal to 3.0 cm or causing symptoms is allowed
- Stereotactic radiosurgery or prior radiotherapy completed at least 2 weeks before starting dendritic cell vaccine
- Recovery from any major surgery before starting treatment
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
- Adequate organ and marrow function based on specified laboratory values
- No evidence of leptomeningeal disease
- Steroid use limited to prednisone 10 mg daily or less
- Life expectancy greater than 3 months
- Prior checkpoint inhibitor therapy permitted if given at least 3 weeks before enrollment
- Continued HER2-directed antibody treatment or chemotherapy allowed under specific conditions
- Management of systemic disease progression as detailed in the study protocol
You will not qualify if you...
- Any condition that may interfere with study participation or results as judged by the investigator
- Symptomatic brain metastases not resolved by local therapy
- Participation in other investigational agent studies within 4 weeks before starting treatment
- Chemotherapy or targeted therapy within 4 weeks or 5 half-lives before starting treatment or unresolved adverse events from prior therapies
- Rapidly progressing systemic disease preventing completion of vaccine doses
- Active autoimmune disease requiring systemic treatment in the past 2 years
- History of allogenic tissue or organ transplantation
- Active infection requiring systemic therapy
- Known active hepatitis B or C infection
- Known immunosuppressive disease such as HIV/AIDS
- Blood transfusion within 2 weeks prior to leukapheresis
- Pregnant or actively nursing participants unwilling to stop nursing
- Inability or unwillingness to follow protocol requirements
- Brain lesion causing significant midline shift or obstructive hydrocephalus
- Use of corticosteroids above prednisone 10 mg daily for cerebral edema or neurologic symptoms
- History of 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 starting dendritic cell vaccine
- Live vaccine within 30 days before first study drug dose except seasonal influenza injection
- Diagnosis of immunodeficiency or chronic systemic steroid therapy exceeding 10 mg prednisone equivalent
- Known additional malignancy progressing or actively treated within 3 years except certain skin and in situ cancers
- Positive pregnancy test at screening or before leukapheresis
- Known active carcinomatous meningitis
- Psychiatric or substance abuse disorders interfering with trial participation
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
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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