Triple Therapy for Breast Cancer

Palo Alto (17 mi)

Overseen byRoisin Connolly, MD

Age: 18+

Sex: Any

Travel: May be covered

Time Reimbursement: Varies

Trial Phase: Phase 1

Waitlist Available

Sponsor: National Cancer Institute (NCI)

No Placebo Group

Breakthrough Therapy

Trial Summary

What is the purpose of this trial?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.

Eligibility Criteria

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.

Inclusion Criteria

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 am 18 years old or older.

My kidney function, measured by creatinine levels or clearance, is normal.

My oxygen levels stay above 90% when I move around without needing extra oxygen.

I am fully active or able to carry out light work.

Exclusion Criteria

I do not have lung disease that causes symptoms or could affect lung toxicity treatment.

I do not have any severe illnesses that would stop me from following the study's requirements.

I am not taking valproic acid.

Treatment Details

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.

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.

Entinostat is already approved in China, European Union for the following indications:

🇨🇳 Approved in China as Entinostat for: