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

Part of paid clinical trials in Duarte, California.

Sponsor
National Cancer Institute (NCI)
Study ID
NCT02453620
Phase
PHASE1
Status
Active Not Recruiting

Conditions

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

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Biopsy Procedure — PROCEDURE
    Undergo tissue biopsy
  • Blood Sample — OTHER
    Undergo blood sample collection
  • Bone Scan — PROCEDURE
    Undergo bone scan
  • Computed Tomography — PROCEDURE
    Undergo CT or PET/CT
  • Entinostat — DRUG
    Given PO
  • Ipilimumab — BIOLOGICAL
    Given IV
  • Nivolumab — BIOLOGICAL
    Given IV
  • Pharmacogenomic Study — OTHER
    Correlative studies
  • Pharmacological Study — OTHER
    Correlative studies
  • Positron Emission Tomography — PROCEDURE
    Undergo PET/CT

Study Details

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.

Key Dates

Start date
Feb 12, 2016
Status verified
Mar 2026
Primary completion
Apr 22, 2021
Completion
Sep 17, 2026

Study Design

Enrollment
57 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Treatment (entinostat, nivolumab, ipilimumab)
    Patients receive entinostat PO on days -14 and -7 and then weekly, nivolumab IV over 60 minutes on day 1 and then every 2 weeks, and ipilimumab IV over 90 minutes on day 1 and then every 6 weeks for 4 doses. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients undergo CT as clinically indicated throughout the trial. Patients may undergo PET/CT or bone scan throughout the trial. Patients also undergo tissue biopsy and blood sample collection during screening and on the trial.

Primary Outcome Measure

Incidence of adverse events of entinostat and nivolumab in combination with ipilimumab [ Time Frame: Up to 100 days after last dose of nivolumab ]

Locations (5)

FacilityCityStateZIPSite coordinators
City of Hope Comprehensive Cancer CenterDuarteCalifornia91010-
Smilow Cancer Center/Yale-New Haven HospitalNew HavenConnecticut06510-
Yale UniversityNew HavenConnecticut06520-
Johns Hopkins University/Sidney Kimmel Cancer CenterBaltimoreMaryland21287-
University of Pittsburgh Cancer Institute (UPCI)PittsburghPennsylvania15232-

Find similar trials in Duarte, CA

By research site
City of Hope Comprehensive Cancer Center· Duarte, CASmilow Cancer Center/Yale-New Haven Hospital· New Haven, CTYale University· New Haven, CTJohns Hopkins University/Sidney Kimmel Cancer Center· Baltimore, MDUniversity of Pittsburgh Cancer Institute (UPCI)· Pittsburgh, PA

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