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NCT04348747 · ClinicalTrials.gov registry record · Phase 2
Dendritic Cell Vaccines Against Her2/Her3 and Pembrolizumab for the Treatment of Brain Metastasis From Triple Negative Breast Cancer or HER2+ Breast Cancer
A Phase 2 study of Anatomic Stage IV Breast Cancer AJCC v8 and Metastatic Malignant Neoplasm in the Brain, sponsored by Roswell Park Cancer Institute.
- Recruiting
- Registry status
- Phase 2
- Development phase
- 23
- Enrollment target
- 3
- Study locations
NCT04348747: Recruiting Phase 2 study of Anatomic Stage IV Breast Cancer AJCC v8 and Metastatic Malignant Neoplasm in the Brain, sponsored by Roswell Park Cancer Institute.
NCT04348747 is a Phase 2 study of Anatomic Stage IV Breast Cancer AJCC v8 and Metastatic Malignant Neoplasm in the Brain that is actively recruiting participants, run by Roswell Park Cancer Institute. The registered enrollment target is 23 participants, below the 166-participant average among 59 other Anatomic Stage IV Breast Cancer AJCC v8 trials with a reported enrollment target (86% lower). The trial reports 3 study locations across 3 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04348747, a Phase 2 study of Anatomic Stage IV Breast Cancer AJCC v8 and Metastatic Malignant Neoplasm in the Brain, is actively recruiting participants, sponsored by Roswell Park Cancer Institute.
- RECRUITING
- Registry status
- Phase 2
- Development phase
- 23 participants
- Enrollment target
- 3
- Study locations
Study Summary
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.
Primary Outcome
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.
Conditions Studied
Interventions
- BIOLOGICAL Pembrolizumab
- BIOLOGICAL Anti-HER2/HER3 Dendritic Cell Vaccine
Study Locations (3)
Florida
- Moffitt Cancer Center - Tampa
New York
- Roswell Park Cancer Institute - Buffalo
Virginia
- University of Virginia Comprehensive Cancer Center - Charlottesville
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 23 participants |
| Start Date | 2022-12-19 |
| Est. Completion | 2027-12-15 |
| Phase | Phase 2 |
What NCT04348747 shows while recruiting
NCT04348747 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 23 participants, a relatively small participant target, below the 166-participant average among 59 other Anatomic Stage IV Breast Cancer AJCC v8 trials with a reported enrollment target (86% lower).
The record links to 4 conditions, with Anatomic Stage IV Breast Cancer AJCC v8 appearing as the primary indexed condition, and to 2 interventions - of which Pembrolizumab is the first listed.
NCT04348747 reports a single indexed study location in Florida, New York, Virginia.
Frequently Asked Questions
What is clinical trial NCT04348747 about?
NCT04348747 is a clinical study titled "Dendritic Cell Vaccines Against Her2/Her3 and Pembrolizumab for the Treatment of Brain Metastasis From Triple Negative Breast Cancer or HER2+ Breast Cancer". 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 ...
What is the current status of trial NCT04348747?
This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 23 participants. The study started on 2022-12-19. Estimated completion is 2027-12-15.
What conditions does trial NCT04348747 study?
This clinical trial studies the following 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.
What interventions are being tested in trial NCT04348747?
The interventions under investigation include: Pembrolizumab (BIOLOGICAL), Anti-HER2/HER3 Dendritic Cell Vaccine (BIOLOGICAL).
Who is sponsoring clinical trial NCT04348747?
This trial is sponsored by Roswell Park Cancer Institute, which has 365 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04348747 being conducted?
This trial has 3 study locations across Florida, New York, Virginia. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT04348747's enrollment target sits among peer trials
23 44th of 59 higher than 15 of 59 other Anatomic Stage IV Breast Cancer AJCC v8 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Anatomic Stage IV Breast Cancer AJCC v8 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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