A Randomized Phase II Study of Pembrolizumab an anti-PD (programmed cell death)-1 Antibody in Combination with Carboplatin Compared to Carboplatin Alone in Breast Cancer Patients with Chest Wall Disease
Are you eligible to participate in this study?
You may be eligible for this study if you meet the following criteria:
Conditions: chest wall disease | breast cancer
Age: Between 18 - 100 Years
Gender: Male or Female
Advanced breast cancer with locally recurrent chest wall disease not amenable to surgical excision
Either triple negative disease or hormone receptor positive, HER2 negative disease with evidence of progression on at lease two prior lines of hormone therapy
Any number of prior lines of therapy are allowed
At least two weeks from last systemic therapy for breast cancer, with recovery of all treatment related toxicity to grade 1 or less
At least two weeks from last radiation therapy, with recovery of all treatment related toxicity to grade 1 or less
Prior CNS disease is allowed if stable for at least one month since whole brain radiation therapy, and 2 weeks since stereotactic radiotherapy, and not requiring steroids
Able to provide tissue from a newly obtained core or excisional biopsy of a chest wall tumor lesion
Adequate organ function
Female patients of childbearing potential should have a negative urine or serum pregnancy within 72 hours prior to receiving the first dose of study medication
Female subjects of childbearing potential should be willing to use an acceptable form of birth control or be surgically sterile, or abstain from heterosexual activity for the course of the study through 120 days after the last dose of study medication
Male subjects should agree to use an adequate method of contraception starting with the first dose of study therapy through 120 days after the last dose of study therapy
Treatment with an investigational agent within 4 weeks of the first dose of treatment
A diagnosis of immunodeficiency or is currently receiving systemic steroid therapy at any dose or is receiving any other form of immunosuppressive therapy. Steroid therapy is not allowed within 7 days prior to the first dose of trial treatment. However, topical and intranasal corticosteroids are allowed, and not an exclusion for participation.
Known active TB (Bacillus Tuberculosis). Patients with a distant history of tuberculosis that was appropriately treated and have no evidence of active infection are eligible to participate. Patients with a history of latent tuberculosis that was appropriately treated are also eligible to participate.
Hypersensitivity to pembrolizumab or any of its excipients.
Hypersensitivity to carboplatin or cisplatin.
Has had prior chemotherapy, targeted small molecule therapy, or radiation therapy within 2 weeks prior to study Day 1 or who has not recovered from adverse events due to a previously administered agent
Has a known additional malignancy that is progressing or requires active treatment. Exceptions include basal cell carcinoma of the skin or squamous cell carcinoma of the skin that has undergone potentially curative therapy or in situ cervical cancer.
Has known active central nervous system (CNS) metastases and/or carcinomatous meningitis.
Has active autoimmune disease that has required systemic treatment in the past 2 years (i.e., with use of disease modifying agents, corticosteroids or immunosuppressive drugs). Replacement therapy (e.g., thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency, etc.) is not considered a form of systemic treatment.
Has active pneumonitis requiring treatment with steroids or active interstitial lung disease.
Has an active infection requiring systemic therapy.
Has a history or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the trial, interfere with the subject?s participation for the full duration of the trial, or is not in the best interest of the subject to participate, in the opinion of the treating investigator.
Has known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial.
Is pregnant or breastfeeding, or expecting to conceive or father children within the projected duration of the trial, screening visit through 120 days after the last dose of trial treatment.
Has received prior therapy with an anti-PD-1, anti-PD-L1, or anti-PD-L2 agent. Has been on any prior Merck MK-3475 (pembrolizumab) studies.
Has a known history of Human Immunodeficiency Virus (HIV) (HIV 1/2 antibodies).
Has known active Hepatitis B (e.g., HBsAg reactive) or Hepatitis C (e.g., HCV RNA [qualitative] is detected).
Has received a live vaccine within 30 days of planned start of study therapy.