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NCT06324240 · ClinicalTrials.gov registry record · Phase 1
Personalized Vaccine Immunotherapy in Combination With Checkpoint Inhibitor for Treatment of Triple Negative Breast Cancer
A Phase 1 study of Anatomic Stage III Breast Cancer AJCC v8 and Anatomic Stage II Breast Cancer AJCC v8, sponsored by Emory University.
- Recruiting
- Registry status
- Phase 1
- Development phase
- 18
- Enrollment target
- 4
- Study locations
NCT06324240: Recruiting Phase 1 study of Anatomic Stage III Breast Cancer AJCC v8 and Anatomic Stage II Breast Cancer AJCC v8, sponsored by Emory University.
NCT06324240 is a Phase 1 study of Anatomic Stage III Breast Cancer AJCC v8 and Anatomic Stage II Breast Cancer AJCC v8 that is actively recruiting participants, run by Emory University. The registered enrollment target is 18 participants, below the 305-participant average among 84 other Anatomic Stage III Breast Cancer AJCC v8 trials with a reported enrollment target (94% lower). The trial reports 4 study locations across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06324240, a Phase 1 study of Anatomic Stage III Breast Cancer AJCC v8 and Anatomic Stage II Breast Cancer AJCC v8, is actively recruiting participants, sponsored by Emory University.
- RECRUITING
- Registry status
- Phase 1
- Development phase
- 18 participants
- Enrollment target
- 4
- Study locations
Study Summary
This phase I trial tests the safety, side effects, and best dose of a personalized vaccine (tumor membrane vesicle or TMV vaccine) by itself and in combination with checkpoint inhibitor (pembrolizumab or ipilimumab) in treating patients with triple negative breast cancer. This vaccine is made by taking a piece of patient's triple negative breast cancer to design a vaccine to stimulate the immune system's memory. Patients are treated with the personalized vaccine immunotherapy with or without monoclonal antibodies, such as pembrolizumab and ipilimumab. This approach may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Giving personalized TMV vaccine with pembrolizumab or ipilimumab may help the immune system attack cancer better and reduce the risk of this breast cancer coming back or growing.
Primary Outcome
Safety and tolerability will be assessed by adverse events (AE), vital signs, physical exam findings, clinical laboratory safety assessments and incidence of treatment-emergent AE. AE events will be assessed according to Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 and will be evaluated by grade and organ class.
Conditions Studied
Interventions
- BIOLOGICAL Pembrolizumab
- BIOLOGICAL Ipilimumab
- BIOLOGICAL Vaccine Therapy
Study Locations (4)
Georgia
- Grady Health System - Atlanta
- Emory University Hospital Midtown - Atlanta
- Emory University Hospital/Winship Cancer Institute - Atlanta
- Emory Saint Joseph's Hospital - Atlanta
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 18 participants |
| Start Date | 2025-12-02 |
| Est. Completion | 2026-12-31 |
| Phase | Phase 1 |
What NCT06324240 shows while recruiting
NCT06324240 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 18 participants, a relatively small participant target, below the 305-participant average among 84 other Anatomic Stage III Breast Cancer AJCC v8 trials with a reported enrollment target (94% lower).
The record links to 10 conditions, with Anatomic Stage III Breast Cancer AJCC v8 appearing as the primary indexed condition, and to 3 interventions - of which Pembrolizumab is the first listed.
NCT06324240 reports a single indexed study location in Georgia.
Frequently Asked Questions
What is clinical trial NCT06324240 about?
NCT06324240 is a clinical study titled "Personalized Vaccine Immunotherapy in Combination With Checkpoint Inhibitor for Treatment of Triple Negative Breast Cancer". This phase I trial tests the safety, side effects, and best dose of a personalized vaccine (tumor membrane vesicle or TMV vaccine) by itself and in combination with checkpoint inhibitor (pembrolizumab or ipilimumab) in treating patients with triple negative breast cancer. This vaccine is made by tak...
What is the current status of trial NCT06324240?
This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 18 participants. The study started on 2025-12-02. Estimated completion is 2026-12-31.
What conditions does trial NCT06324240 study?
This clinical trial studies the following conditions: Anatomic Stage III Breast Cancer AJCC v8, Anatomic Stage II Breast Cancer AJCC v8, Anatomic Stage I Breast Cancer AJCC v8, Anatomic Stage IIIA Breast Cancer AJCC v8, Anatomic Stage IIA Breast Cancer AJCC v8.
What interventions are being tested in trial NCT06324240?
The interventions under investigation include: Pembrolizumab (BIOLOGICAL), Ipilimumab (BIOLOGICAL), Vaccine Therapy (BIOLOGICAL).
Who is sponsoring clinical trial NCT06324240?
This trial is sponsored by Emory University, which has 1,208 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06324240 being conducted?
This trial has 4 study locations across Georgia. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Anatomic Stage III Breast Cancer AJCC v8
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT06324240's enrollment target sits among peer trials
18 77th of 84 higher than 5 of 84 other Anatomic Stage III Breast Cancer AJCC v8 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Anatomic Stage III 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.
Source ClinicalTrials.gov registry export · 2026-08-08
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