A Randomized Phase II Clinical Trial Assessing the Efficacy and Safety of MK-3475 (Pembrolizumab) in Combination With Carboplatin and Gemcitabine in Patients With Metastatic Triple Negative Breast Cancer

K
Kathy Miller, MD

Primary Investigator

Overview

The main purpose of this study is to see if Pembrolizumab in combination with chemotherapy (carboplatin and gemcitabine) is safe and effective in treating patients with metastatic triple negative breast cancer.

Description

The main purpose of this study is to see if Pembrolizumab in combination with chemotherapy (carboplatin and gemcitabine) is safe and effective in treating patients with metastatic triple negative breast cancer.

Eligibility

You may be eligible for this study if you meet the following criteria:

  • Conditions:
    breast cancer
  • Age: Between 18 Years - 100 Years
  • Gender: Female

Inclusion Criteria
Women diagnosed with pathologically confirmed metastatic triple negative invasive breast cancer (centrally confirmed immunophenotype negative for all three receptors ER, PR and HER2)
Have either evaluable disease, or have measurable clinical disease
Patients received up to 2 prior regimens for their disease in the metastatic setting
Patients are candidates for chemotherapy with carboplatin and gemcitabine
Demonstrate adequate organ function
Exclusion Criteria
Patients participating in another trial of an investigational agent within 4 weeks of the first dose of the study
Patients who received prior therapy using carboplatin/gemcitabine less than 12 months from the beginning of their enrollment or subjects whose tumor progressed while on treatment with carboplatin or cisplatin
Patients with baseline grade 2 neuropathy
Diagnosis of immunosuppression or receiving steroid therapy or other immunosuppressive therapy within 4 weeks of the study
Active autoimmune disease or a documented history of autoimmune disease, or a syndrome that has required systemic treatment in the past 2 years
Has evidence of interstitial lung disease or active, non-infectious pneumonitis
Has had a prior monoclonal antibody within 4 weeks prior to study Day 1 or who has not recovered (i.e., ? Grade 1 or at baseline) from adverse events due to agents administered more than 4 weeks earlier
Has had prior chemotherapy, targeted small molecule therapy, or radiation therapy within 2 weeks prior to study Day 1 or who has not recovered (i.e., ? Grade 1 or at baseline) from adverse events due to a previously administered agent
If subject received major surgery, they must have recovered adequately from the toxicity and/or complications from the intervention prior to starting therapy
Known additional malignancy that progressed and/or required treatment in the last 5 years. Except that for basal and squamous cell carcinoma of the skin or in situ cervical carcinoma that has completed potentially curative therapy
Life expectancy of less than 3 months
Prior therapy with an anti-programmed cell death 1 (PD-1), anti-programmed cell death 1 ligand (PDL-1), anti-PD-L2, anti-CD137 antibody, or anti-cytotoxic T-lymphocyte -associated antigen-4 (CTLA-4) antibody
Pregnant, breastfeeding, or expecting to conceive children within the projected time of the trial, starting with the pre-screening or screening visit and through 120 days after the last dose of trial treatment
Active infection requiring systemic therapy
Has known active central nervous system (CNS) metastases and/or carcinomatous meningitis. Subjects with previously treated brain metastases may participate provided they are stable (without evidence of progression by imaging for at least four weeks prior to the first dose of trial treatment and any neurologic symptoms have returned to baseline), have no evidence of new or enlarging brain metastases, and are not using steroids for at least 7 days prior to trial treatment
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 received a live vaccine within 30 days prior to the first dose of trial treatment


Additional Information:
Participants will not be paid for their participation.

Updated on 20 Nov 2022. Study ID: 1704195527 (BR-076)

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