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NCT06492759 · ClinicalTrials.gov registry record · Phase 2
High Dose Radiation Therapy With Pembrolizumab and Chemotherapy for the Treatment of Patients With PD-L1 Positive Metastatic Triple Negative Breast Cancer
A Phase 2 study, sponsored by Emory University.
- Recruiting
- Registry status
- Phase 2
- Development phase
- 29
- Enrollment target
NCT06492759: Recruiting Phase 2 study, sponsored by Emory University.
NCT06492759 is a Phase 2 study that is actively recruiting participants, run by Emory University. The registered enrollment target is 29 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (78% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06492759, a Phase 2 study, is actively recruiting participants, sponsored by Emory University.
- RECRUITING
- Registry status
- Phase 2
- Development phase
- 29 participants
- Enrollment target
Study Summary
This phase II trial tests how well radiation therapy with pembrolizumab and chemotherapy (paclitaxel or nab-paclitaxel or carboplatin and gemcitabine) works in treating patients with PD-L1 positive triple negative breast cancer that has spread from where it first started (primary site) to other places in the body (metastatic). Radiation therapy uses high energy x-rays, particles, or radioactive seeds to kill tumor cells and shrink tumors. Immunotherapy with monoclonal antibodies, such as pembrolizumab, may help the body's immune system attack the tumor, and may interfere with the ability of tumor cells to grow and spread. Paclitaxel is in a class of medications called antimicrotubule agents. It stops cancer cells from growing and dividing and may kill them. Nab-paclitaxel is an albumin-stabilized nanoparticle formulation of paclitaxel which may have fewer side effects and work better than other forms of paclitaxel. Carboplatin is in a class of medications known as platinum-containing compounds. It works by killing, stopping or slowing the growth of cancer cells. Gemcitabine is a chemotherapy drug that blocks the cells from making DNA and may kill cancer cells. High dose radiation therapy with pembrolizumab and chemotherapy may effective in treating patients with PD-L1 positive metastatic triple negative breast cancer.
Primary Outcome
Progressive disease will be determined by Response Evaluation Criteria in Solid Tumors (RECIST) version (v)1.1. PFS will be estimated using the Kaplan-Meier method, and a 95% confidence interval for 1-year PFS will be estimated using the Greenwood formula. The 1-year PFS estimate will be compared to a null value of 30% using a one-sample log-rank test.
Interventions
- BIOLOGICAL Pembrolizumab
- DRUG Carboplatin
- DRUG Paclitaxel
- RADIATION Radiation Therapy
- DRUG Nab-paclitaxel
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 29 participants |
| Start Date | 2025-10-22 |
| Est. Completion | 2028-02-13 |
| Phase | Phase 2 |
What NCT06492759 shows while recruiting
NCT06492759 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 29 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (78% lower).
The record links to 0 conditions, and to 5 interventions - of which Pembrolizumab is the first listed.
NCT06492759 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT06492759 about?
NCT06492759 is a clinical study titled "High Dose Radiation Therapy With Pembrolizumab and Chemotherapy for the Treatment of Patients With PD-L1 Positive Metastatic Triple Negative Breast Cancer". This phase II trial tests how well radiation therapy with pembrolizumab and chemotherapy (paclitaxel or nab-paclitaxel or carboplatin and gemcitabine) works in treating patients with PD-L1 positive triple negative breast cancer that has spread from where it first started (primary site) to other plac...
What is the current status of trial NCT06492759?
This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 29 participants. The study started on 2025-10-22. Estimated completion is 2028-02-13.
What interventions are being tested in trial NCT06492759?
The interventions under investigation include: Pembrolizumab (BIOLOGICAL), Carboplatin (DRUG), Paclitaxel (DRUG), Radiation Therapy (RADIATION), Nab-paclitaxel (DRUG).
Who is sponsoring clinical trial NCT06492759?
This trial is sponsored by Emory University, which has 1,208 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT06492759's enrollment target sits among peer trials
29 1669th of 2000 higher than 324 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 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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