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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

StatusActive, Not Recruiting
PhasePhase 1
Started
View on ClinicalTrials.gov ↗

Record History

The 50 most recent of 116 record versions are accounted for below. See every version on ClinicalTrials.gov ↗

  1. Completion pushed from Sep 17, 2026 to Sep 11, 2027 Eligibility criteria revised · Study description revised · Site details revised at 2 of 5 sites Show 3 more changesShow less
    • Eligibility criteria revised
    • Study description revised
    • Site details revised at 2 of 5 sites
  2. Study Status, Contacts/Locationsv115
  3. 20 versions Re-verified since Mar 13, 2026, no change to tracked fieldsv95-v114
  4. Completion date: Sep 17, 2025 to Sep 17, 2026v94
  5. 2 versions Re-verified since Sep 2, 2025, no change to tracked fieldsv92-v93
Show 25 earlier versionsHide 25 earlier versions
  1. Interventions: Biopsy (Procedure), Blood Sample (Other), Bone Scan (Procedure), Computed Tomography (Procedure), Entinostat (Drug), Ipilimumab… to Biopsy Procedure (Procedure), Blood Sample (Other), Bone Scan (Procedure), Computed Tomography (Procedure), Entinostat (Drug), Ipilimumab…v91
  2. 2 versions Re-verified since Mar 4, 2025, no change to tracked fieldsv89-v90
  3. Completion date: Aug 30, 2024 to Sep 17, 2025v88
  4. 6 versions Re-verified since Sep 22, 2023, no change to tracked fieldsv82-v87
  5. Start date: Nov 6, 2015 to Feb 12, 2016 Completion date: Feb 22, 2024 to Aug 30, 2024 · Interventions: Entinostat (Drug), Ipilimumab (Biological), Nivolumab (Biological), Pharmacogenomic Study (Other), Pharmacological Study (Other) to Biopsy (Procedure), Blood Sample (Other), Bone Scan (Procedure), Computed Tomography (Procedure), Entinostat (Drug), Ipilimumab… · Eligibility criteria expanded, about 41 wordsv81 Show 3 more changesShow less
    • Completion date: Feb 22, 2024 to Aug 30, 2024
    • Interventions: Entinostat (Drug), Ipilimumab (Biological), Nivolumab (Biological), Pharmacogenomic Study (Other), Pharmacological Study (Other) to Biopsy (Procedure), Blood Sample (Other), Bone Scan (Procedure), Computed Tomography (Procedure), Entinostat (Drug), Ipilimumab…
    • Eligibility criteria expanded, about 41 words

    See this version in full on ClinicalTrials.gov ↗

  6. Primary completion date: Nov 29, 2019 to Apr 22, 2021 Completion date: Feb 13, 2024 to Feb 22, 2024v80 Show 1 more changeShow less
    • Completion date: Feb 13, 2024 to Feb 22, 2024
  7. Enrollment target: estimated 45 to confirmed 57 Primary completion date changed from estimate of Dec 30, 2023 to Nov 29, 2019 · Completion date: Dec 30, 2023 to Feb 13, 2024v79 Show 2 more changesShow less
    • Primary completion date changed from estimate of Dec 30, 2023 to Nov 29, 2019
    • Completion date: Dec 30, 2023 to Feb 13, 2024
  8. Primary and study completion dates: Dec 30, 2022 to Dec 30, 2023v78
  9. 5 versions Re-verified since Apr 5, 2022, no change to tracked fieldsv73-v77
  10. Primary completion date: Dec 30, 2021 to Dec 30, 2022 Completion date: Dec 30, 2022v72 Show 1 more changeShow less
    • Completion date: Dec 30, 2022
  11. 3 versions Re-verified since Apr 2, 2021, no change to tracked fieldsv69-v71
  12. Study Status, Eligibilityv68
  13. Re-verified, no change to tracked fieldsv67
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT02453620
Lead Sponsor National Cancer Institute (NCI)
Conditions Anatomic Stage III Breast Cancer AJCC v8, Anatomic Stage IV Breast Cancer AJCC v8, Breast Adenocarcinoma, Invasive Breast Carcinoma, Malignant Solid Neoplasm
Enrollment 57 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov