deltatrials
Active Not Recruiting PHASE1 INTERVENTIONAL 1-arm NCT02453620

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 Evaluating Safety, Tolerability, and Preliminary Antitumor Activity of Entinostat and Nivolumab With or Without Ipilimumab in Advanced Solid Tumors

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
Interventions Biopsy Procedure Blood Sample Bone Scan Computed Tomography Entinostat Ipilimumab Nivolumab Pharmacogenomic Study Pharmacological Study Positron Emission Tomography
Updated 45 times since 2017 Last updated: Oct 1, 2025 Started: Feb 12, 2016 Primary completion: Apr 22, 2021 Completion: Sep 17, 2026
This information is for research purposes only and is not medical advice. Consult a healthcare provider before making any medical decision.

A PHASE1 clinical study on Anatomic Stage III Breast Cancer AJCC v8 and Anatomic Stage IV Breast Cancer AJCC v8, this trial is ongoing. The trial is conducted by National Cancer Institute (NCI) and has accumulated 45 data snapshots since 2016. Oncology trials at this stage typically focus on safety, tolerability, and early efficacy signals.

Status Flow

~Jan 2017 – ~Feb 2017 · 31 days · monthly snapshot~Feb 2017 – ~Apr 2017 · 59 days · monthly snapshot~Apr 2017 – ~Jun 2017 · 2 months · monthly snapshot~Jun 2017 – ~Nov 2017 · 5 months · monthly snapshot~Nov 2017 – ~Dec 2017 · 30 days · monthly snapshot~Dec 2017 – ~Jun 2018 · 6 months · monthly snapshot~Jun 2018 – ~Dec 2018 · 6 months · monthly snapshot~Dec 2018 – ~Mar 2019 · 3 months · monthly snapshot~Mar 2019 – ~Apr 2019 · 31 days · monthly snapshot~Apr 2019 – ~May 2019 · 30 days · monthly snapshot~May 2019 – ~Aug 2019 · 3 months · monthly snapshot~Aug 2019 – ~Sep 2019 · 31 days · monthly snapshot~Sep 2019 – ~Nov 2019 · 2 months · monthly snapshot~Nov 2019 – ~Jan 2020 · 2 months · monthly snapshot~Jan 2020 – ~Feb 2020 · 31 days · monthly snapshot~Feb 2020 – ~Apr 2020 · 2 months · monthly snapshot~Apr 2020 – ~May 2020 · 30 days · monthly snapshot~May 2020 – ~Jun 2020 · 31 days · monthly snapshot~Jun 2020 – ~Oct 2020 · 4 months · monthly snapshot~Oct 2020 – ~Jan 2021 · 3 months · monthly snapshot~Jan 2021 – ~Feb 2021 · 31 days · monthly snapshot~Feb 2021 – ~Apr 2021 · 59 days · monthly snapshot~Apr 2021 – ~May 2021 · 30 days · monthly snapshot~May 2021 – ~Sep 2021 · 4 months · monthly snapshot~Sep 2021 – ~Nov 2021 · 2 months · monthly snapshot~Nov 2021 – ~Feb 2022 · 3 months · monthly snapshot~Feb 2022 – ~May 2022 · 3 months · monthly snapshot~May 2022 – ~Jul 2022 · 2 months · monthly snapshot~Jul 2022 – ~Sep 2022 · 2 months · monthly snapshot~Sep 2022 – ~Dec 2022 · 3 months · monthly snapshot~Dec 2022 – ~Feb 2023 · 2 months · monthly snapshot~Feb 2023 – ~Mar 2023 · 28 days · monthly snapshot~Mar 2023 – ~Oct 2023 · 7 months · monthly snapshot~Oct 2023 – ~Dec 2023 · 2 months · monthly snapshot~Dec 2023 – ~Mar 2024 · 3 months · monthly snapshot~Mar 2024 – ~Apr 2024 · 31 days · monthly snapshot~Apr 2024 – ~Jul 2024 · 3 months · monthly snapshot~Jul 2024 – ~Aug 2024 · 31 days · monthly snapshot~Aug 2024 – ~Sep 2024 · 31 days · monthly snapshot~Sep 2024 – ~Oct 2024 · 30 days · monthly snapshot~Oct 2024 – ~Apr 2025 · 6 months · monthly snapshot~Apr 2025 – ~May 2025 · 30 days · monthly snapshot~May 2025 – ~Oct 2025 · 5 months · monthly snapshot~Oct 2025 – ~Nov 2025 · 31 days · monthly snapshot~Nov 2025 – present · 9 months · monthly snapshot

Change History

45 versions recorded

  1. Nov 2025 — Present [monthly]

    Active Not Recruiting PHASE1

  2. Oct 2025 — Nov 2025 [monthly]

    Active Not Recruiting PHASE1

  3. May 2025 — Oct 2025 [monthly]

    Active Not Recruiting PHASE1

  4. Apr 2025 — May 2025 [monthly]

    Active Not Recruiting PHASE1

  5. Oct 2024 — Apr 2025 [monthly]

    Active Not Recruiting PHASE1

▶ Show 40 earlier versions

  1. Sep 2024 — Oct 2024 [monthly]

    Active Not Recruiting PHASE1

  2. Aug 2024 — Sep 2024 [monthly]

    Active Not Recruiting PHASE1

  3. Jul 2024 — Aug 2024 [monthly]

    Active Not Recruiting PHASE1

  4. Apr 2024 — Jul 2024 [monthly]

    Active Not Recruiting PHASE1

  5. Mar 2024 — Apr 2024 [monthly]

    Active Not Recruiting PHASE1

  6. Dec 2023 — Mar 2024 [monthly]

    Active Not Recruiting PHASE1

  7. Oct 2023 — Dec 2023 [monthly]

    Active Not Recruiting PHASE1

  8. Mar 2023 — Oct 2023 [monthly]

    Active Not Recruiting PHASE1

  9. Feb 2023 — Mar 2023 [monthly]

    Active Not Recruiting PHASE1

  10. Dec 2022 — Feb 2023 [monthly]

    Active Not Recruiting PHASE1

  11. Sep 2022 — Dec 2022 [monthly]

    Active Not Recruiting PHASE1

  12. Jul 2022 — Sep 2022 [monthly]

    Active Not Recruiting PHASE1

  13. May 2022 — Jul 2022 [monthly]

    Active Not Recruiting PHASE1

  14. Feb 2022 — May 2022 [monthly]

    Active Not Recruiting PHASE1

  15. Nov 2021 — Feb 2022 [monthly]

    Active Not Recruiting PHASE1

  16. Sep 2021 — Nov 2021 [monthly]

    Active Not Recruiting PHASE1

  17. May 2021 — Sep 2021 [monthly]

    Active Not Recruiting PHASE1

  18. Apr 2021 — May 2021 [monthly]

    Active Not Recruiting PHASE1

  19. Feb 2021 — Apr 2021 [monthly]

    Active Not Recruiting PHASE1

  20. Jan 2021 — Feb 2021 [monthly]

    Active Not Recruiting PHASE1

  21. Oct 2020 — Jan 2021 [monthly]

    Active Not Recruiting PHASE1

  22. Jun 2020 — Oct 2020 [monthly]

    Active Not Recruiting PHASE1

  23. May 2020 — Jun 2020 [monthly]

    Active Not Recruiting PHASE1

  24. Apr 2020 — May 2020 [monthly]

    Active Not Recruiting PHASE1

  25. Feb 2020 — Apr 2020 [monthly]

    Active Not Recruiting PHASE1

    Status: Recruiting → Active Not Recruiting

  26. Jan 2020 — Feb 2020 [monthly]

    Recruiting PHASE1

  27. Nov 2019 — Jan 2020 [monthly]

    Recruiting PHASE1

  28. Sep 2019 — Nov 2019 [monthly]

    Recruiting PHASE1

  29. Aug 2019 — Sep 2019 [monthly]

    Recruiting PHASE1

  30. May 2019 — Aug 2019 [monthly]

    Recruiting PHASE1

  31. Apr 2019 — May 2019 [monthly]

    Recruiting PHASE1

  32. Mar 2019 — Apr 2019 [monthly]

    Recruiting PHASE1

  33. Dec 2018 — Mar 2019 [monthly]

    Recruiting PHASE1

  34. Jun 2018 — Dec 2018 [monthly]

    Recruiting PHASE1

  35. Dec 2017 — Jun 2018 [monthly]

    Recruiting PHASE1

  36. Nov 2017 — Dec 2017 [monthly]

    Recruiting PHASE1

  37. Jun 2017 — Nov 2017 [monthly]

    Recruiting PHASE1

  38. Apr 2017 — Jun 2017 [monthly]

    Recruiting PHASE1

  39. Feb 2017 — Apr 2017 [monthly]

    Recruiting PHASE1

  40. Jan 2017 — Feb 2017 [monthly]

    Recruiting PHASE1

    First recorded

Feb 2016

Trial started

Per CT.gov start date — pre-dates our first snapshot

Eligibility Summary

No eligibility information available.

Contact Information

Sponsor contact:
  • National Cancer Institute (NCI)
Data source: National Cancer Institute (NCI)

For direct contact, visit the study record on ClinicalTrials.gov .

Study Locations