None listed
Conditions
Interventions
Arm 1: Pembrolizumab (MK-3475) 200 mg IV every 3-weeks
Arm 2: Investigator’s choice of:
- Paclitaxel 80-100 mg/m2 on Days 1, 8, and 15 of every 28-day (4-week)
cycle, OR
- Docetaxel 75 mg/
Sponsors
MERCK SHARP & DOHME PERU S.R.L.,
Eligibility
Sex/Gender
All
Age
18 Years to 100 Years
Inclusion criteria
Inclusion criteria: -Provide written informed consent -≥ 18 years of age -histologically or cytologically-confirmed diagnosis of adenocarcinoma or squamous cell carcinoma of the esophagus or Siewert type I adenocarcinoma of the EGJ. HER-2/neu negative tumors are eligible. HER2/neu positive tumors must have documentation of disease progression on treatment containing trastuzumab -Metastatic disease or locally advanced, unresectable disease -Life expectancy of greater than 3 months -Measurable disease based on RECIST 1.1 -Performance status of 0 or 1 on the Eastern Cooperative Oncology Group (ECOG) Performance Scale -Have experienced documented objective radiographic or clinical disease progression during or after first-line locally or globally recommended therapy -Provide a tissue sample for intratumoral immune-related GEP analysis -Female subjects of childbearing potential must have a negative urine or serum pregnancy test within 72 hours prior to receiving the first dose of study medication -Must be willing to use an adequate method of contraception; male participants should also agree not to not to donate sperm starting with the first dose of study therapy through 120 days after the last dose of pembrolizumab or through 180 days after the last dose of paclitaxel, docetaxel or irinotecan.
Exclusion criteria
Exclusion criteria: -Participating and receiving study therapy (or in the past) -4 weeks of 1st dose -Active autoimmune disease that has required systemic treatment -2 years -Immunodeficiency or receiving systemic steroid or immunosuppresive therapy -7 days of 1st dose -Active CNS metastases and/or carcinomatous meningitis -Prior anti-cancer monoclonal antibody, chemotherapy, targeted small molecule therapy, or radiation - 2 weeks prior to Day 1 or not recovered from AE -Prior therapy with an anti-PD-1, anti-PD-L1, or anti-PD-L2 agent, or if participated in pembrolizumab trial -Additional malignancy- 5 years prior to randomization -Live vaccine -30 days of 1st dose -history or current evidence of any condition, therapy, or laboratory abnormality that might confound the results -Know history of HIV -Known active Hepatitis B or C -History or evidence of interstitial lung disease or active, noninfectious pneumonitis -Active infection requiring systemic therapy -Psychiatric or substance abuse disorders -Pregnant or breastfeeding, or expecting to conceive or father children within the projected duration of trial -known allergy, hypersensitivity, or contraindication to paclitaxel, docetaxel, or irinotecan -Is or has an immediate family member who is investigational site or sponsor staff directly involved with this trial
Countries
Australia, Brazil, Canada, China, Colombia, Czech Republic, Denmark, Estonia, Finland, France, Germany, Ireland, Israel, Italy, Japan, Korea South, Malasya, Mexico, Netherlands, Norway, Peru, Portugal, Russian Federation, Singapore, Spain, Sweden, Taiwan, Thailand, Turkey, United Kindgdom, United States
Contacts
Public ContactNelva Garcia
MERCK SHARP & DOHME PERU S.R.L
Outcome results
None listed