None listed
Conditions
Interventions
Cohort 1: Pembrolizumab as monotherapy in 3L+ subjects.
Cohort 2: Pembrolizumab in combination with cisplatin + 5-FU in 1L subjects.
Cohort 3: Pembrolizumab as monotherapy in PD-L1 positive 1
Day 1 of each 3 week cycle up to 2 years.
Cisplatin. Dose 80 mg/m2
Day 1 of each 3 week cycle for 6 cycles.
5-Fluorouracil: Dose 800 mg/m2
Continuous 5-day IV infusion
Day 1-5 of each 3 week cycle for 6 cycles.
Treatment will continue until documented confirmed disease progression (DP), unacceptable adverse event(s), intercurrent illness that prevents further ad
Sponsors
MERCK SHARP & DOHME PERU S.R.L.,
Eligibility
Sex/Gender
All
Age
18 Years to 100 Years
Inclusion criteria
Inclusion criteria: Cohort 1: 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.
Exclusion criteria
Exclusion criteria: 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
Countries
Chile, Colombia, Estonia, France, Israel, Italy, Japan, Korea South, Liechtenstein, Lithuania, Peru, Portugal, Romania, Russian Federation, United Kindgdom, United States
Contacts
Public ContactNelva Garcia
MERCK SHARP & DOHME PERU S.R.L
Outcome results
None listed