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NCT05318469 · ClinicalTrials.gov registry record · Phase 1
Ivermectin in Combination With Balstilimab or Pembrolizumab in Patients With Metastatic Triple Negative Breast Cancer
A Phase 1 study of Anatomic Stage IV Breast Cancer AJCC v8 and Metastatic Triple-Negative Breast Carcinoma, sponsored by Yuan Yuan.
- Recruiting
- Registry status
- Phase 1
- Development phase
- 34
- Enrollment target
- 1
- Study location
NCT05318469 is a Phase 1 study of Anatomic Stage IV Breast Cancer AJCC v8 and Metastatic Triple-Negative Breast Carcinoma that is actively recruiting participants, run by Yuan Yuan. The registered enrollment target is 34 participants, below the 166-participant average among 59 other Anatomic Stage IV Breast Cancer AJCC v8 trials with a reported enrollment target (80% lower). The trial reports 1 study location across 1 state.
The verdict
NCT05318469, a Phase 1 study of Anatomic Stage IV Breast Cancer AJCC v8 and Metastatic Triple-Negative Breast Carcinoma, is actively recruiting participants, sponsored by Yuan Yuan.
- RECRUITING
- Registry status
- Phase 1
- Development phase
- 34 participants
- Enrollment target
- 1
- Study location
Study Summary
This phase II trial studies the side effects and best dose of ivermectin in combination with balstilimab or pembrolizumab and to see how well they they work in shrinking tumors in patients with triple negative breast cancer that has spread to other places in the body (metastatic). Immunotherapy with monoclonal antibodies, such as balstilimab or pembrolizumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Ivermectin may help block the formation of growths that may become cancer. Giving ivermectin with balstilimab or pembrolizumab may increase the effect of balstilimab or pembrolizumab in shrinking tumors in patients with triple negative breast cancer. The secondary objectives of the study include evaluating the following efficacy outcomes: objective response rate (ORR), progression free survival (PFS), overall survival (OS), duration of response (DOR), clinical benefit rate (CBR), and patients' quality of life (QOL) by European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire Core 30 (QLQ-C30).
Conditions Studied
Interventions
- DRUG Pembrolizumab
- DRUG Ivermectin
- DRUG Balstilmab
Study Locations (1)
California
- Cedars-Sinai Medical Center - Los Angeles
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 34 participants |
| Start Date | 2023-10-13 |
| Est. Completion | 2026-10 |
| Phase | Phase 1 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05318469
The ClinicalTrials.gov registry entry for NCT05318469 describes a study currently listed as recruiting, categorized as Phase 1. The registered enrollment target is 34 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 166-participant average among 59 other Anatomic Stage IV Breast Cancer AJCC v8 trials with a reported enrollment target (80% lower). The listed sponsor is Yuan Yuan, which has 3 total studies on file at ClinicalTrials.gov.
The record links to 2 conditions, with Anatomic Stage IV Breast Cancer AJCC v8 appearing as the primary indexed condition, and to 3 interventions - of which Pembrolizumab is the first listed.
NCT05318469 reports 1 study location spanning 1 distinct geographic area - top geographies include California.
Frequently Asked Questions
What is clinical trial NCT05318469 about?
NCT05318469 is a clinical study titled "Ivermectin in Combination With Balstilimab or Pembrolizumab in Patients With Metastatic Triple Negative Breast Cancer". This phase II trial studies the side effects and best dose of ivermectin in combination with balstilimab or pembrolizumab and to see how well they they work in shrinking tumors in patients with triple negative breast cancer that has spread to other places in the body (metastatic). Immunotherapy with...
What is the current status of trial NCT05318469?
This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 34 participants. The study started on 2023-10-13. Estimated completion is 2026-10.
What conditions does trial NCT05318469 study?
This clinical trial studies the following conditions: Anatomic Stage IV Breast Cancer AJCC v8, Metastatic Triple-Negative Breast Carcinoma.
What interventions are being tested in trial NCT05318469?
The interventions under investigation include: Pembrolizumab (DRUG), Ivermectin (DRUG), Balstilmab (DRUG).
Who is sponsoring clinical trial NCT05318469?
This trial is sponsored by Yuan Yuan, which has 3 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05318469 being conducted?
This trial has 1 study location across California. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Anatomic Stage IV Breast Cancer AJCC v8
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