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)

MERCK SHARP & DOHME PERU S.R.L.,0 个研究点目标入组 8 人开始时间: 2016年3月23日最近更新: 2023年9月4日

适应症

试验速览

暂无简介。

•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

发起方

MERCK SHARP & DOHME PERU S.R.L.,