A RANDOMIZED OPEN-LABEL PHASE III STUDY OF SINGLE AGENT PEMBROLIZUMAB VERSUS SINGLEAGENT CHEMOTHERAPY PER PHYSICIAN’S CHOICE FOR METASTATIC TRIPLE NEGATIVE BREAST CANCER(MTNBC) – (KEYNOTE-119)
- Conditions
- -C50 Malignant neoplasm of breastMalignant neoplasm of breastC50
- Registration Number
- PER-066-15
- Lead Sponsor
- MERCK SHARP & DOHME PERU S.R.L.,
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 8
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.
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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method