Triple Therapy for Breast Cancer

Recruiting in Palo Alto (17 mi)

+4 other locations

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

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.

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

+17 more

Exclusion 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.

+11 more

Participant Groups

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: