Dendritic Cell Vaccines Against Her2/Her3 and Pembrolizumab for the Treatment of Brain Metastasis From Triple Negative Breast Cancer or HER2+ Breast Cancer

Part of paid clinical trials in Tampa, Florida.

Sponsor
Roswell Park Cancer Institute
Study ID
NCT04348747
Phase
PHASE2
Status
Recruiting
Apply to this trial

Conditions

  • Anatomic Stage IV Breast Cancer AJCC v8
  • Metastatic Malignant Neoplasm in the Brain
  • Metastatic Triple-Negative Breast Carcinoma
  • Prognostic Stage IV Breast Cancer AJCC v8

Eligibility Criteria

Sex
FEMALE
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Anti-HER2/HER3 Dendritic Cell Vaccine — BIOLOGICAL
    Given ID
  • Pembrolizumab — BIOLOGICAL
    Given IV

Study Details

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.

Key Dates

Start date
Dec 19, 2022
Status verified
May 2026
Primary completion
Jun 15, 2027
Completion
Dec 15, 2027

Study Design

Enrollment
23 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Treatment (anti-HER2/3 dendritic cell vaccine)
    TREATMENT PHASE: Patients receive anti-HER2/HER3 dendritic cell vaccine ID on days 1, 22, and 43. Patients will also receive pembrolizumab IV on the same days. MAINTENANCE PHASE: Patients receive pembrolizumab IV over 30 minutes on day 1. Cycles repeat every 21 days for 2 years in the absence of disease progression or unacceptable toxicity. Patients may also receive a booster dose of anti-HER2/3 dendritic cell vaccine ID, every 3-6 months in the opinion of principal investigator.

Primary Outcome Measure

Central nervous system (CNS) objective response rate (ORR) [ Time Frame: Within 6 months of treatment start date ]

Locations (3)

FacilityCityStateZIPSite coordinators
Moffitt Cancer CenterTampaFlorida33612-
Roswell Park Cancer InstituteBuffaloNew York14263
Sheheryar Kabraji, BMBCh
[email protected]
716-845-1486
Sheheryar Kabraji (PRINCIPAL_INVESTIGATOR)
University of Virginia Comprehensive Cancer CenterCharlottesvilleVirginia22903
Patrick Dillon, MD
[email protected]
434-924-8073
Patrick Dillon, MD (PRINCIPAL_INVESTIGATOR)

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By research site
Moffitt Cancer Center· Tampa, FLRoswell Park Cancer Institute· Buffalo, NYUniversity of Virginia Comprehensive Cancer Center· Charlottesville, VA

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