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NCT02453620 · ClinicalTrials.gov registry record · Phase 1
Entinostat, Nivolumab, and Ipilimumab in Treating Patients With Solid Tumors That Are Metastatic or Cannot Be Removed by Surgery or Locally Advanced or Metastatic HER2-Negative Breast Cancer
A Phase 1 study of Malignant Solid Neoplasm and Anatomic Stage III Breast Cancer AJCC v8, sponsored by National Cancer Institute (NCI).
- Active
- Registry status
- Phase 1
- Development phase
- 57
- Enrollment target
- 5
- Study locations
NCT02453620 is a Phase 1 study of Malignant Solid Neoplasm and Anatomic Stage III Breast Cancer AJCC v8 that is active but no longer recruiting, run by National Cancer Institute (NCI). The registered enrollment target is 57 participants, below the 1,141-participant average among 176 other Malignant Solid Neoplasm trials with a reported enrollment target (95% lower). The trial reports 5 study locations across 4 states.
The verdict
NCT02453620, a Phase 1 study of Malignant Solid Neoplasm and Anatomic Stage III Breast Cancer AJCC v8, is active but no longer recruiting, sponsored by National Cancer Institute (NCI).
- ACTIVE NOT RECRUITING
- Registry status
- Phase 1
- Development phase
- 57 participants
- Enrollment target
- 5
- Study locations
Study Summary
This phase I trial studies the side effects and best dose of entinostat and nivolumab when given together with ipilimumab in treating patients with solid tumors that have spread to other places in the body and usually cannot be cured or controlled with treatment (metastatic) or that cannot be removed by surgery (unresectable) or human epidermal growth factor receptor 2 (HER2)-negative breast cancer that has spread from where it started to nearby tissue or lymph nodes or other parts of the body. Entinostat is in a class of drugs called histone deacetylase (HDAC) inhibitors. It may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth (locally advanced/metastatic). Immunotherapy with monoclonal antibodies, such as nivolumab and ipilimumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Giving entinostat and nivolumab together with ipilimumab may work better in treating in patients with solid tumors.
Conditions Studied
Interventions
- PROCEDURE Computed Tomography
- PROCEDURE Biopsy Procedure
- PROCEDURE Bone Scan
- DRUG Entinostat
- OTHER Blood Sample
Study Locations (5)
Connecticut
- Smilow Cancer Center/Yale-New Haven Hospital - New Haven
- Yale University - New Haven
California
- City of Hope Comprehensive Cancer Center - Duarte
Maryland
- Johns Hopkins University/Sidney Kimmel Cancer Center - Baltimore
Pennsylvania
- University of Pittsburgh Cancer Institute (UPCI) - Pittsburgh
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 57 participants |
| Start Date | 2016-02-12 |
| Est. Completion | 2026-09-17 |
| Phase | Phase 1 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02453620
The ClinicalTrials.gov registry entry for NCT02453620 describes a study currently listed as active not recruiting, categorized as Phase 1. The registered enrollment target is 57 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 1,141-participant average among 176 other Malignant Solid Neoplasm trials with a reported enrollment target (95% lower). The listed sponsor is National Cancer Institute (NCI), which has 3,257 total studies on file at ClinicalTrials.gov.
The record links to 5 conditions, with Malignant Solid Neoplasm appearing as the primary indexed condition, and to 5 interventions - of which Computed Tomography is the first listed.
NCT02453620 reports 5 study locations spanning 4 distinct geographic areas - top geographies include Connecticut, California, Maryland.
Frequently Asked Questions
What is clinical trial NCT02453620 about?
NCT02453620 is a clinical study titled "Entinostat, Nivolumab, and Ipilimumab in Treating Patients With Solid Tumors That Are Metastatic or Cannot Be Removed by Surgery or Locally Advanced or Metastatic HER2-Negative Breast Cancer". This phase I trial studies the side effects and best dose of entinostat and nivolumab when given together with ipilimumab in treating patients with solid tumors that have spread to other places in the body and usually cannot be cured or controlled with treatment (metastatic) or that cannot be remove...
What is the current status of trial NCT02453620?
This trial is currently active not recruiting. It is a Phase 1 study. The enrollment target is 57 participants. The study started on 2016-02-12. Estimated completion is 2026-09-17.
What conditions does trial NCT02453620 study?
This clinical trial studies the following conditions: Malignant Solid Neoplasm, Anatomic Stage III Breast Cancer AJCC v8, Anatomic Stage IV Breast Cancer AJCC v8, Invasive Breast Carcinoma, Breast Adenocarcinoma.
What interventions are being tested in trial NCT02453620?
The interventions under investigation include: Computed Tomography (PROCEDURE), Biopsy Procedure (PROCEDURE), Bone Scan (PROCEDURE), Entinostat (DRUG), Blood Sample (OTHER).
Who is sponsoring clinical trial NCT02453620?
This trial is sponsored by National Cancer Institute (NCI), which has 3,257 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT02453620 being conducted?
This trial has 5 study locations across California, Connecticut, Maryland, Pennsylvania. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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