OncRef

Clinical Trial: 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

Status:

ACTIVE NOT RECRUITING

Phase:

Phase 1

Lead Sponsor:National Cancer Institute (NCI)
Information Provided By:National Cancer Institute (NCI)
Last Update Posted:2026-09-15

Study Overview

Brief 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.

Official Title

A Phase 1 Study Evaluating Safety, Tolerability, and Preliminary Antitumor Activity of Entinostat and Nivolumab With or Without Ipilimumab in Advanced Solid Tumors

Conditions

Anatomic Stage III Breast Cancer AJCC v8, Anatomic Stage IV Breast Cancer AJCC v8, Breast Adenocarcinoma, Invasive Breast Carcinoma, Malignant Solid Neoplasm

Intervention / Treatment

  • Procedure: Biopsy Procedure
  • Other: Blood Sample
  • Procedure: Bone Scan
  • Procedure: Computed Tomography
  • Drug: Entinostat
  • Biological: Ipilimumab
  • Biological: Nivolumab
  • Other: Pharmacogenomic Study
  • Other: Pharmacological Study
  • Procedure: Positron Emission Tomography

Other Study ID Numbers

  • NCI-2015-00741
  • NCI-2015-00741
  • SKCCC J15221
  • L9844
  • J15221
  • 9844
  • 9844
  • UM1CA186689
  • UM1CA186690
  • UM1CA186691
  • UM1CA186717

Start Date (Actual)

2016-02-12

Primary Completion Date (Actual)

2021-04-22

Study Completion Date (Estimated)

2027-09-11

Enrollment (Actual)

57

Study Type

Interventional

Phase

Phase 1