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Dendritic Cell Vaccine + Pembrolizumab for Brain Metastasis from Breast Cancer
Study Summary
This trial is testing a dendritic cell vaccine in patients with either triple negative breast cancer or HER2+ breast cancer that has spread to the brain. The vaccine is designed to boost the immune system to recognize and destroy the cancer cells. Pembrolizumab is also being given in this trial. 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. The hope is that by giving both the vaccine and pembrolizumab, the cancer
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowTimeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Trial Design
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- I last used checkpoint inhibitors 3 weeks ago or more.I have an active hepatitis B or C infection.My illness is quickly getting worse, which may stop me from getting all vaccine doses.I have not had a stroke or mini-stroke in the last 6 months.I have been treated for an autoimmune disease in the last 2 years.I haven't had chemotherapy or targeted therapy within 4 weeks or before I fully recovered from their side effects.I have a brain tumor causing significant pressure or fluid buildup.I have another cancer that is growing or was treated in the last 3 years.I have an immune system disorder or have been on high-dose steroids or other immune-weakening medicines recently.I have or had lung inflammation that needed steroids.I can continue certain treatments if my breast cancer has spread to my brain.I am not pregnant or breastfeeding and follow the study's birth control requirements.My organ and bone marrow function is good, tested within the last 10 days.I have brain disease that can be measured and is larger than 0.5 cm.I am fully active or can carry out light work.You cannot have an MRI for medical reasons.I've had whole brain radiation before for my recurring, worsening brain cancer.You are expected to live for more than 3 months.I have not had radiotherapy or stereotactic radiosurgery within the last 2 weeks.My cancer has spread to the lining of my brain and spinal cord.I have an infection needing treatment that may increase my risk in the trial.I haven't been part of any clinical trials or used experimental treatments in the last 4 weeks.I had radiosurgery or radiotherapy at least 2 weeks before my first DC vaccine dose.You have had a transplant using tissue or organs from another person.I have brain metastases that are causing symptoms.My breast cancer is triple negative.I am not pregnant or nursing, or I agree to stop nursing.I have a condition that weakens my immune system, like HIV or AIDS.I have received a blood transfusion within the last two weeks.I have not received a live vaccine in the last 30 days.I have fully recovered from any major surgery before starting treatment.
- Group 1: Treatment (anti-HER2/3 dendritic cell vaccine)
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
What other scientific investigations have been conducted to evaluate the Anti-HER2/HER3 Dendritic Cell Vaccine?
"Currently, 1026 studies are active for the Anti-HER2/HER3 Dendritic Cell Vaccine with 137 trials in Phase 3. Although there is a significant presence of these clinical investigations in Scottsdale, Arizona, they span 39733 sites across the world."
How many participants are enrolled in this clinical trial?
"Affirmative. Clinicaltrials.gov currently displays data indicating that this research is actively searching for participants, with 23 patients needed from one medical centre. This clinical trial was initially posted on April 7th 2022 and most recently updated on April 29th 2022."
Is Anti-HER2/HER3 Dendritic Cell Vaccine hazardous for human health?
"Our team at Power assigned a safety rating of 2 to the Anti-HER2/HER3 Dendritic Cell Vaccine as this is still in its Phase 2 trial stage, with evidence backing its security but not yet any proof of effectiveness."
Are recruitment efforts underway for this research endeavor?
"Affirmative. Clinicaltrials.gov confirms that this research, which was first posted on April 7th 2022, is actively recruiting participants. 23 individuals are required to be recruited from one centre for the trial's completion."
In what conditions is Anti-HER2/HER3 Dendritic Cell Vaccine a viable treatment option?
"The Anti-HER2/HER3 Dendritic Cell Vaccine is prescribed to treat cancerous growths, as well as conditions such as microsatellite instability high, unresectable melanoma, and hepatitis c virus (HCV) infection."
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