Dendritic Cell Vaccines Against Her2/Her3 and Pembrolizumab for the Treatment of Brain Metastasis From Triple Negative Breast Cancer or HER2+ Breast Cancer
Eligible age
18+ yrs
Accepts
Women
Locations
3 states
Healthy volunteers
No
See if you qualify for this study
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About this study
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.
Sponsor: Roswell Park Cancer Institute
You may qualify if…
- ✓ female participant is eligible to participate if she is not pregnant,not breastfeeding, and at least one of the following conditions applies:
- ✓ Not a woman of childbearing potential (WOCBP)
- ✓ A WOCBP who agrees to follow contraceptive guidance
- ✓ WOCBP must agree to use acceptable birth control methods for the duration of the study and until persistence of the study drug is no longer detected in the peripheral blood:this may be a period of several years. Methods for acceptable birth control include: condoms, diaphragm or cervical cap with spermicide, intrauterine device, and hormonal contraception; it is recommended that a combination of two methods be used. NOTE: If the risk of conception exists, patients must agree to use highly effective contraception throughout the study and for at least two years following the last study treatment administration
- ✓ Negative serum and highly sensitive urine pregnancy test(s):
- ✓ At initial screening prior to eligibility confirmation
- ✓ within 72 hours prior to leukapheresis if \>72 hours have passed between screening test and the Leukapheresis visit
- ✓ Pregnancy testing will be performed for WOCBP and interpreted prior to every cycle of pembrolizumab (Initial Treatment Phase);
You may not qualify if…
- ✕ Any condition which might confound the results of the study, interfere with the subject's participation for full participation (for the full duration of the study) or in the Investigator's opinion deems the participant an unsuitable candidate for the study
- ✕ Symptomatic brain metastases. Any neurologic symptoms present must have resolved with local therapy by the time of administration of study drugs
- ✕ May not be receiving any other investigational agents and may not have participated in a study of an investigational agent or using an investigational device within 4 weeks of the first dose of DC vaccine treatment
- ✕ Has had prior chemotherapy or targeted small molecule therapy (except treatment mentioned in inclusion criteria 17) within 4 weeks or 5 half-lives (whichever is sooner) prior to start of treatment (first DC vaccine) or who has not recovered (i.e., =\< grade 1 or at baseline) from adverse events due to a previously administered agent. Previous radiation to extracranial sites may be completed at any time prior to initiation of study drugs (first DC vaccine) with a 2-week washout is required.
- ✕ Rapidly progressing systemic disease which might interfere with completion of all the vaccine doses
- ✕ Active autoimmune disease that has required systemic treatment in the past 2 years (i.e. with use of disease modifying agents, corticosteroids or immunosuppressive drugs). Replacement therapy (e.g., thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency, etc.) is not considered a form of systemic treatment and is allowed
- ✕ History of allogenic tissue/solid organ transplantation
- ✕ Has an active infection requiring systemic therapy which in the investigator's opinion will increase risk to the patient
Where it's recruiting
Source: ClinicalTrials.gov · NCT04348747 · last updated 2026-05-11