Study on Dendritic Cell Vaccines and Pembrolizumab for Treating Brain Metastasis from Triple Negative or HER2+ Breast Cancer
Sponsor: Roswell Park Cancer Institute
ClinicalTrials ID:NCT04348747
This clinical trial is exploring a new treatment using dendritic cell vaccines and pembrolizumab to help the immune system fight brain metastases in patients with triple negative or HER2+ breast cancer.
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Program Overview
This study is testing how well dendritic cell vaccines, combined with pembrolizumab, work in treating brain metastases from triple negative breast cancer or HER2+ breast cancer. Dendritic cell vaccines aim to boost the immune system to recognize and destroy cancer cells, while pembrolizumab helps enhance the body's existing immune response against cancer. The goal is to see if this combination can shrink the cancer.
Description
The study has two main phases: Treatment and Maintenance.
Treatment Phase:
- Patients receive dendritic cell vaccines against HER2/HER3 under the skin on days 1, 22, and 43.
- Pembrolizumab is given through an IV on the same days.
Maintenance Phase:
- Patients continue to receive pembrolizumab every 21 days for up to 2 years, as long as the disease does not progress and side effects are manageable.
- A booster dose of the dendritic cell vaccine may be given every 3-6 months, based on the doctor's decision.
Primary Objective:
- To assess the best response of brain metastases using specific criteria.
Secondary Objectives:
- Measure the size of brain metastases.
- Evaluate the response of cancer outside the brain.
- Determine the time patients live without the disease getting worse and overall survival.
- Assess the safety of the treatment.
- Check how many patients do not need further treatment for brain metastases after 6 months.
- Monitor the failure rate of treated lesions.
Eligibility Criteria
Inclusion Criteria
- Female participants who are not pregnant or breastfeeding.
- Women of childbearing potential must agree to use effective birth control during the study and for a period after.
- Negative pregnancy tests are required at various points during the study.
- Diagnosed with triple negative breast cancer or HER2+ breast cancer.
- Have measurable brain metastases that meet specific size criteria.
- Have not received certain treatments recently or have recovered from them.
- Good overall health with specific blood and organ function levels.
- Life expectancy of more than 3 months.
- Previous treatments with checkpoint inhibitors are allowed under certain conditions.
- Willing to follow study procedures and provide informed consent.
Exclusion Criteria
- Conditions that could interfere with the study results or participation.
- Symptomatic brain metastases that have not been resolved with local therapy.
- Participation in another investigational study recently.
- Rapidly progressing disease that could prevent completion of the study.
- Active autoimmune disease requiring treatment in the past 2 years.
- History of organ transplantation.
- Active infections or known hepatitis B or C.
- Known immunosuppressive diseases.
- Recent blood transfusions.
- Pregnant or nursing women.
- Significant brain lesions or conditions affecting the brain.
- Recent use of certain medications or treatments.
- Known psychiatric or substance abuse disorders affecting participation.
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