A PHASE II CLINICAL TRIAL OF PEMBROLIZUMAB AS MONOTHERAPY AND IN COMBINATION WITH CISPLATIN+5-FLUOROURACIL IN SUBJECTS WITH RECURRENT OR METASTATIC GASTRIC OR GASTROESOPHAGEAL JUNCTION ADENOCARCINOMA (KEYNOTE-059)

MERCK SHARP & DOHME PERU S.R.L.,0 个研究点目标入组 1 人开始时间: 2015年7月7日最近更新: 2023年9月4日

适应症

试验速览

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•1 Have received, and progressed on, at least 2 prior chemotherapy regimens
•2 HER-2/neu neg, or, HER2/neu pos previously treated with trastuzumab
•Cohorts 2 or 3:
•3 HER2/neu neg
•4 Have not received prior systemic anti-cancer therapy for their metastatic or advanced gastric or gastroesophageal junction adenocarcinoma
•For all potential subjects:
•5 Provide written informed consent
•6 Be >= 18 years of age
•7 Have histologically or cytologically-confirmed recurrent or metastatic gastric or gastroesophageal junction adenocarcinoma incurable by local therapies
•8 Provide tissue for PD-L1 biomarker analysis from a newly-obtained endoscopic tumor biopsy from the stomach and/or gastroesophageal junction
•9 Be PD-L1 pos, if allocated to a cohort only enrolling PD-L1 pos subjects
•10 Have measurable disease based on RECIST 1.1
•11 Have a performance status of 0 or 1 on the ECOG Performance Scale
•12 Female of childbearing potential should use 2 methods of birth control or be surgically sterile, or abstain from heterosexual activity for the course of the study through 120 or 180 days after the last dose of study drug
•Male should use an adequate method of contraception starting with the first dose of study through 120 or 180 days after the last dose of study drug
•13 Demonstrate adequate organ function
•14 Female of childbearing potential have a negative urine or serum pregnancy test within 72h prior to receiving the first dose of study drug.

•1 Is or has participated in a study of an investigational agent
•2 Has active autoimmune disease
•3 Has a diagnosis of immunodeficiency or is receiving systemic steroid therapy
•4 Has had a prior anti-cancer monoclonal antibody (mAb)
•5 Has had prior chemotherapy, targeted small molecule therapy, or radiation therapy
•6 Has a known additional malignancy that is progressing or requires active treatment.
•7 Has known active central nervous system (CNS) metastases and/or carcinomatous meningitis.
•8 Has known history of, or any evidence of active, non-infectious pneumonitis.
•9 Has an active infection requiring systemic therapy.
•10 Has a history or current evidence of any condition, therapy, or laboratory abnormality
•11 Has known psychiatric or substance abuse disorders
•12 Is pregnant or breastfeeding, or expecting to conceive or father children within the trial, through 120 or 180 days after the last dose of treatment
•13 Has received prior therapy with an anti-PD-1, anti-PD-L1 or anti-PD-L2 agent, or has previously in Merck MK-3475 clinical trials
•14 Has a known history of HIV
•15 Has known active Hepatitis B or C
•16 Has received a live vaccine within 30 days of start of therapy
•17 Is or has an immediate family member who is investigational site or sponsor staff directly involved with this trial

发起方

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