Approval Probability
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ML Risk
Anti-HER2/HER3 Dendritic Cell Vaccine · 1 trial · 4 indications
Assessed per Response Assessment in Neuro-Oncology Brain Metastases (RANO-BM) working group. Will be summarized using frequencies and relative frequencies. A 90% confidence interval about the true ORR will be obtained using Jeffrey's prior method.
| Arm | Type | Description |
|---|---|---|
| Treatment (anti-HER2/3 dendritic cell vaccine) | EXPERIMENTAL | 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. |
| Name | Type | Description |
|---|---|---|
| Anti-HER2/HER3 Dendritic Cell Vaccine | BIOLOGICAL | Given ID |
| Pembrolizumab | BIOLOGICAL | Given IV |
Inclusion Criteria: * 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 ac...
Anti-HER2/HER3 Dendritic Cell Vaccine is an investigational cancer vaccine being studied for the treatment of Anatomic Stage IV Breast Cancer AJCC v8, including metastatic triple-negative breast carcinoma and HER2-positive breast cancer with brain metastasis. It is currently in Phase 2 clinical development and has not been approved by the FDA.
Anti-HER2/HER3 Dendritic Cell Vaccine targets the HER2 and HER3 receptors, which are proteins involved in the growth of certain breast cancers. The vaccine is designed to stimulate the immune system to recognize and attack cancer cells expressing these targets.
Anti-HER2/HER3 Dendritic Cell Vaccine is being developed by United Therapeutics Corporation, a biotechnology company traded on the NASDAQ under the ticker symbol UTHR. The company is conducting a Phase 2 clinical trial to evaluate the vaccine in patients with advanced breast cancer.
Anti-HER2/HER3 Dendritic Cell Vaccine is in Phase 2 clinical development. It is an investigational agent, meaning it has not been approved by the FDA and is still being studied for safety and efficacy in clinical trials.
Anti-HER2/HER3 Dendritic Cell Vaccine is being evaluated in a single Phase 2 clinical trial with the identifier NCT04348747. This trial is recruiting female patients aged 18 years and older with brain metastasis from triple-negative or HER2-positive breast cancer, and it is being conducted in the United States.