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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
Must not have
Subjects with interstitial lung disease that is symptomatic or may interfere with the detection or management of suspected drug-related pulmonary toxicity; NOTE: subjects must have baseline oxygen/saturation level requirements as above
Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that in the judgment of the investigator would limit compliance with study requirements
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Awards & highlights
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 belowSelect...
My cancer is advanced, cannot be surgically removed, and standard treatments haven't worked or aren't suitable.
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My breast cancer is advanced, HER2-negative, and didn't respond to standard treatments.
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I am 18 years old or older.
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My kidney function, measured by creatinine levels or clearance, is normal.
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My oxygen levels stay above 90% when I move around without needing extra oxygen.
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I am fully active or able to carry out light work.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I do not have lung disease that causes symptoms or could affect lung toxicity treatment.
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I do not have any severe illnesses that would stop me from following the study's requirements.
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I am not taking valproic acid.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 5 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
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 moreOther 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 moreTrial 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
Bone Scan
2015
Completed Phase 2
~50
Positron Emission Tomography
2008
Completed Phase 2
~2210
Computed Tomography
2017
Completed Phase 2
~2720
Entinostat
2017
Completed Phase 2
~1210
Ipilimumab
2014
Completed Phase 3
~2610
Biopsy
2014
Completed Phase 4
~1090
Nivolumab
2014
Completed Phase 3
~4740
Find a Location
Who is running the clinical trial?
National Cancer Institute (NCI)Lead Sponsor
13,748 Previous Clinical Trials
40,959,344 Total Patients Enrolled
944 Trials studying Breast Cancer
1,544,008 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
Eligibility Criteria:
This trial includes the following eligibility criteria:- I do not have HIV, hepatitis B, or hepatitis C.You are allergic to entinostat, nivolumab, or ipilimumab, or have had a severe allergic reaction to any monoclonal antibody.Patients with certain autoimmune diseases or a history of these diseases that may affect vital organ function or require immune suppressive treatment should be excluded. This includes diseases such as multiple sclerosis, lupus, and inflammatory bowel disease. However, patients with certain autoimmune conditions that are well-controlled with medication may be eligible.Your platelet count is at least 100,000 per microliter.If you are a woman who could become pregnant, you need to have a negative pregnancy test.I do not have lung disease that causes symptoms or could affect lung toxicity treatment.I do not have active brain metastases and have not needed high doses of steroids recently.My oxygen levels stay above 90% when I move around without needing extra oxygen.I can have a biopsy taken from my tumor, not in the bone.I am 18 years old or older.I am using or willing to use birth control during the study and am not pregnant or breastfeeding.I am willing to go back to the hospital where I enrolled for my check-ups.I have been checked for serious gut issues before joining the study.My cancer can be measured or seen but hasn't spread only to my bones.I am not taking valproic acid.I do not have any severe illnesses that would stop me from following the study's requirements.I am not on high-dose steroids or strong immune system medications.My kidney function, measured by creatinine levels or clearance, is normal.I haven't had any cancer except for non-dangerous skin cancer or early-stage cancer in the last 3 years.My cancer is advanced, cannot be surgically removed, and standard treatments haven't worked or aren't suitable.My breast cancer is advanced, HER2-negative, and didn't respond to standard treatments.I have recovered from side effects of any previous cancer treatments.I have recovered from side effects of previous treatments, except for hair loss.Your total bilirubin level should be within a certain range, unless you have Gilbert's syndrome and get special permission from the study's leader.Your body has enough white blood cells called neutrophils.I am fully active or able to carry out light work.Your white blood cell count is at least 3,000 per microliter.You are expected to live for at least 12 weeks.Your hemoglobin level is at least 9.0 grams per deciliter.Women who are pregnant or breastfeeding cannot participate in this study because the study drugs could harm the baby.Your AST and ALT levels in the blood are not more than 2.5 times the normal limit set by the hospital.I have previously used specific cancer drugs like HDAC inhibitors or demethylating agents.
Research Study Groups:
This trial has the following groups:- Group 1: Treatment (entinostat, nivolumab, ipilimumab)
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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