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Triple Therapy for Breast Cancer
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.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowTimeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Trial Design
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Who is running the clinical trial?
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- 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.
- Group 1: Treatment (entinostat, nivolumab, ipilimumab)
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- 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.
Frequently Asked Questions
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."
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."
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."
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."
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."
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."
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