None listed
Conditions
Interventions
1. Pembrolizumab: 200 mg IV Q3W
2. Medications used as treatments of physician´s choice (TPC) will be handled according to local regulations and guidelines in participating countries. Sites may cho
Sponsors
MERCK SHARP & DOHME PERU S.R.L.,
Eligibility
Sex/Gender
All
Age
18 Years to 100 Years
Inclusion criteria
Inclusion criteria: 1 Have signed informed consent 2 Be ≥18 years of age on day of signing informed consent. 3 Have received either one or two prior systemic treatments for metastatic breast cancer and have documented disease progression on the most recent therapy. 4 Have been previously treated with an anthracycline and/or taxane in the (neo)adjuvant or metastatic setting 5 Have centrally confirmed mTNBC 6 Have measurable disease based on RECIST 1.1 7 Have provided a newly obtained core or excisional biopsy from a metastatic, notpreviously irradiated, tumor lesion for central determination of triple-negative breast cancer status and PD-L1 biomarker analysis. 8 Have an ECOG performance status of 0 or 1 assessed within 10 days prior of treatment initiation. 9 Demonstrate adequate organ function 10 Female subjects of childbearing potential must have a negative serum pregnancy testwithin 72 hours prior to randomization and agree to use effective contraception. Male subjects should agree to use an adequate method of contraception starting at randomization through at least 120 days after the last dose of pembrolizumab or TPC, according to local standard of care.
Exclusion criteria
Exclusion criteria: 1Participated in a study of an investigational agent/device and has received it within 4 weeks of randomization 2 Monoclonal antibody (mAb) for direct anti-neoplastic treatment (4 weeks of randomization) 3 Chemotherapy, targeted small molecule therapy, or radiation therapy (2 weeks of randomization) 4 Not recovered from AE due to previous therapy 5 Active autoimmune disease that required systemic treatment (past 2 years) 6 Diagnosis of immunodeficiency or receiving systemic steroid or immunosuppressive therapy (7 days of randomization) 7 Additional malignancy that progressed or required reatment (last 5 years) 8 Known active brain metastases and/or carcinomatous meningitis 9 Active/history of pneumonitis requiring treatment with steroids or active/history of interstitial lung disease. 10 Active infection requiring systemic therapy 11 History or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the trial 12 Known psychiatric or substance abuse disorders 13 Pregnant or breastfeeding, or expecting to conceive or father children 14 Has received prior therapy with an anti-PD-1, anti-PD-L1, anti-PD-L2 agent or with an agent directed to another co-inhibitory T-cell receptor 15 Known history of HIV 16 Known history of Hepatitis B or C 17 Has received a live vaccine (30 days of randomization) 18. Is or has an immediate family member who is part of site staff or sponsor
Countries
Australia, Belgium, Brazil, Colombia, Denmark, France, Germany, Ireland, Italy, Japan, Korea South, Malasya, Netherlands, New Zealand, Peru, Philippines, Poland, Russian Federation, Singapore, South Africa, Spain, Sweden, Switzerland, Taiwan, Thailand, Turkey, United Kindgdom, United States
Contacts
Public ContactMariapia Urgelles
MERCK SHARP & DOHME PERU S.R.L
Outcome results
None listed