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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: Active Phase 1 study of Malignant Solid Neoplasm and Anatomic Stage III Breast Cancer AJCC v8, sponsored by National Cancer Institute (NCI).
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. According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
Graded per National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) version (v)5.0. Safety and tolerability will be analyzed through the incidence of adverse events, serious adverse events, and specific laboratory abnormalities (worst grade) in each arm. Toxicities will be tabulated by type and grade for all doses and presented using frequencies and percentages based on the CTCAE v5.0. The proportion of dose-limiting toxicities at each dose level will be reported with exa
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 |
What the registry record for NCT02453620 still lists
NCT02453620 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 57 participants, a relatively small participant target, below the 1,141-participant average among 176 other Malignant Solid Neoplasm trials with a reported enrollment target (95% lower).
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 lists 5 locations in 4 states (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.
Learn More About Clinical Trials
Similar trials for Malignant Solid Neoplasm
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 NCT02453620's enrollment target sits among peer trials
57 122nd of 176 higher than 55 of 176 other Malignant Solid Neoplasm trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Malignant Solid Neoplasm 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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