← Back to Search

Histone Deacetylase Inhibitor

Triple Therapy for Breast Cancer

Phase 1
Waitlist Available
Led By Roisin M Connolly
Research Sponsored by National Cancer Institute (NCI)
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Dose escalation: patients must have histologically or cytologically confirmed solid tumor malignancy that is metastatic or unresectable and for whom either standard curative or palliative measures do not exist or are no longer effective, or for whom anti-PD-L1/cytotoxic T-lymphocyte antigen (CTLA)-4 is appropriate
Dose expansion: patients must have histologically or cytologically confirmed invasive adenocarcinoma of the breast (human epidermal growth factor receptor 2 [HER2]-negative) that is locally advanced/metastatic and has progressed despite standard therapy; at least 1 prior chemotherapy regimen in the metastatic setting, and two lines of hormonal therapy (administered in the adjuvant or metastatic setting) for patients with hormone receptor-positive disease; NOTE: HER2-negativity will be defined per American Society of Clinical Oncology (ASCO)-College of American Pathologists (CAP) guidelines; patients whose tumors have HER2 immunohistochemistry (IHC) 3+, in situ hybridization (ISH) >= 2.0, or average HER2 copy number >= 6.0 signals per cell are not eligible
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Awards & highlights

Study Summary

This trial is testing entinostat, nivolumab, and ipilimumab to see if they're effective and have manageable side effects in treating patients with metastatic or unresectable solid tumors or HER2-negative breast cancer.

Who is the study for?
Adults with solid tumors that are metastatic/unresectable or HER2-negative breast cancer that's advanced despite treatment. Must have had prior chemotherapy for metastatic breast cancer and hormone therapy if applicable. No active autoimmune diseases, untreated brain metastases, another recent malignancy, or need for immune suppressive drugs.Check my eligibility
What is being tested?
The trial is testing the combination of entinostat (an HDAC inhibitor) with nivolumab and ipilimumab (monoclonal antibodies) to see if they can better treat patients with advanced cancers by inhibiting enzymes needed for cell growth and boosting the immune system's ability to fight cancer.See study design
What are the potential side effects?
Potential side effects include reactions related to the immune system attacking normal organs, infusion-related reactions, fatigue, gastrointestinal issues like bowel perforation risk, blood disorders such as anemia or clotting problems, increased infection risk due to immunosuppression.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
My cancer is advanced, cannot be surgically removed, and standard treatments haven't worked or aren't suitable.
Select...
My breast cancer is advanced, HER2-negative, and didn't respond to standard treatments.
Select...
I am 18 years old or older.
Select...
My kidney function, measured by creatinine levels or clearance, is normal.
Select...
My cancer can be measured or seen but hasn't spread only to my bones.
Select...
My oxygen levels stay above 90% when I move around without needing extra oxygen.
Select...
I can have a biopsy taken from my tumor, not in the bone.
Select...
I am using or willing to use birth control during the study and am not pregnant or breastfeeding.
Select...
I am willing to go back to the hospital where I enrolled for my check-ups.
Select...
I am fully active or able to carry out light work.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Incidence of adverse events of entinostat and nivolumab in combination with ipilimumab
Secondary outcome measures
Changes in ratio of effector T cell (Teff) to regulatory T cell (Treg) in tumor biopsies
Disease control rate (expansion cohort of patients with advanced breast cancer)
Duration of overall response (expansion cohort of patients with advanced breast cancer)
+3 more
Other outcome measures
CD86 gene polymorphisms as genetic determinants of immune mediated adverse events
Changes in candidate gene re-expression in malignant tissue, gene methylation silencing in circulating deoxyribonucleic acid (DNA) and malignant tissue pre and post-therapy
Changes in frequency of T cells recognizing tumor-specific mutant neo-antigens in tumor biopsies pre and post-therapy
+5 more

Trial Design

1Treatment groups
Experimental Treatment
Group I: Treatment (entinostat, nivolumab, ipilimumab)Experimental Treatment10 Interventions
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.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Positron Emission Tomography
2008
Completed Phase 2
~2240
Computed Tomography
2017
Completed Phase 2
~2720
Entinostat
2017
Completed Phase 2
~1170
Ipilimumab
2014
Completed Phase 3
~2670
Biopsy
2014
Completed Phase 4
~850
Nivolumab
2014
Completed Phase 3
~4750

Find a Location

Who is running the clinical trial?

National Cancer Institute (NCI)Lead Sponsor
13,654 Previous Clinical Trials
40,933,096 Total Patients Enrolled
940 Trials studying Breast Cancer
1,543,360 Patients Enrolled for Breast Cancer
Roisin M ConnollyPrincipal InvestigatorJHU Sidney Kimmel Comprehensive Cancer Center LAO
3 Previous Clinical Trials
680 Total Patients Enrolled

Media Library

Entinostat (Histone Deacetylase Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT02453620 — Phase 1
Breast Cancer Research Study Groups: Treatment (entinostat, nivolumab, ipilimumab)
Breast Cancer Clinical Trial 2023: Entinostat Highlights & Side Effects. Trial Name: NCT02453620 — Phase 1
Entinostat (Histone Deacetylase Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT02453620 — Phase 1

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What afflictions has Entinostat been demonstrated to alleviate?

"Entinostat is a recommended therapeutic option for individuals who have resisted anti-angiogenic therapies. Additionally, it can be used as an effective treatment modality for malignant neoplasms, squamous cell carcinoma and unresectable melanomas."

Answered by AI

Are there historical precedents for clinical trials involving Entinostat?

"Back in 2009, the first clinical trials for entinostat were conducted at Texas Children's Hospital. Since then, 562 similar studies have been concluded and there are 778 active ones currently taking place across Baltimore, Maryland."

Answered by AI

What is the aggregate number of participants enrolled in this clinical trial?

"This trial has reached its recruitment quota, as the last update was November 10th 2022. If one is interested in looking into other trials concerning breast cancer, 6669 studies are currently running while 778 seek to evaluate Entinostat's efficacy."

Answered by AI

Are there any openings available for volunteers in this experiment?

"As per the details provided on clinicaltrials.gov, this specific medical trial is not currently recruiting patients. Initially posted in November 6th 2015 and most recently updated on November 10th 2022, it has since ceased patient recruitment; nevertheless 7447 other studies are actively enlisting participants."

Answered by AI

Is Entinostat a reliable medication with minimal risks?

"Due to the limited data available, our experts at Power assign Entinostat a safety rating of 1 on their scale. This is mainly because this trial is only in Phase 1 and has yet to gather sufficient evidence supporting its efficacy or safety."

Answered by AI

Are there any medical facilities in North America engaging with this trial?

"This trial is being conducted at 5 locations, such as Johns Hopkins University/Sidney Kimmel Cancer Center in Baltimore and the University of Pittsburgh Cancer Institute (UPCI) in Pittsburgh. Additionally, Yale University in New Haven will be hosting this study alongside other medical centres."

Answered by AI
~6 spots leftby Apr 2025