Closing Soon
Biological and Drug for Metastatic Triple Negative Breast Cancer, sponsored by Merck Sharp & Dohme Corp.
Get in touch This trial recruits from October 2015 for 100 weeks
Australian Medical Information Centre
Phone: 61 2 8988 8428
Inclusion Criteria
Age: From 18 Years To N/A
Gender: Both
Inclusion Criteria
Centrally confirmed mTNBC
Newly obtained tumor biopsy from metastatic site
Central determination of programmed cell death ligand 1 (PD-L1) tumor status
Received either one or two prior systemic treatments for metastatic breast cancer
Documented disease progression on the most recent therapy
Previously treated with an anthracycline and/or taxane in the neoadjuvant/adjuvant or metastatic setting
Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
Adequate organ function
Exclusion Criteria
Participation in another clinical trial within 4 weeks
Monoclonal antibody (mAb) for direct anti-neoplastic treatment within 4 weeks
Chemotherapy, targeted small molecule therapy, or radiation therapy within at least 2 weeks
Active autoimmune disease that required systemic treatment in the past 2 years
Diagnosed with immunodeficiency or receiving systemic steroid therapy or another form of immunosuppressive therapy within 7 days
Known additional malignancy that required treatment or progressed in last 5 years
Known active brain metastases and/or carcinomatous meningitis
Prior therapy with an anti-programmed cell death (PD)-1, anti-PD-ligand-1 (anti-PD-L1), anti-PD-L2 agent or with an agent directed to another co-inhibitory T-cell receptor (e.g. cytotoxic T-lymphocyte associated protein 4 [CTLA-4], OX-40, CD137) or previously participated in any Merck pembrolizumab (MK-3475) clinical studies
Exclusion Criteria
NCT02555657
A Randomized Open-Label Phase III Study of Single Agent Pembrolizumab Versus Single Agent Chemotherapy Per Physician's Choice for Metastatic Triple Negative Breast Cancer (mTNBC) - (KEYNOTE-119)
Study of Single Agent Pembrolizumab (MK-3475) Versus Single Agent Chemotherapy for Metastatic Triple Negative Breast Cancer (MK-3475-119/KEYNOTE-119)