Study of Pembrolizumab (MK-3475) in Previously-Treated Participants With Advanced Carcinoma of the Esophagus or Esophagogastric Junction (MK-3475-180/KEYNOTE-180)
Condition: Esophageal Carcinoma; Esophagogastric Junction Carcinoma
MeSH terms: Carcinoma; Esophageal Neoplasms
Intervention: pembrolizumab
Intervention description: IV Q3W
Intervention MeSH terms: Pembrolizumab
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 121.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Programmed Cell Death-1 (PD-1, PD1); Programmed Cell Death-Ligand 1 (PD-L1, PDL1); Programmed Cell Death-Ligand 2 (PD-L2, PDL2)

Summary:

      In this study participants with advanced/metastatic adenocarcinoma of the esophagus (EAC),
      squamous cell carcinoma of the esophagus (ESCC), or advanced/metastatic Siewert type I
      adenocarcinoma of the esophagogastric junction (EGJ), who had been previously treated with
      two standard therapies, will be treated with pembrolizumab.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Has an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1

          -  Life expectancy greater than 3 months

          -  Histologically-proven advanced/metastatic adenocarcinoma or squamous cell carcinoma of
             the esophagus or advanced/metastatic Siewert type 1 adenocarcinoma of the EGJ

          -  Documented objective radiographic or clinical disease progression on two previous
             lines of standard therapy

          -  Measurable disease based on Response Evaluation Criteria In Solid Tumors (RECIST) 1.1

          -  Can provide either a newly obtained or archival tumor tissue sample for intratumoral
             immune-related testing and for anti-programmed cell death (PD-1)

          -  Female participants of childbearing potential must be willing to use adequate
             contraception for the course of the study through 120 days after the last dose of
             study medication

          -  Male participants must agree to use adequate contraception starting with the first
             dose through 120 days after the last dose of study medication

          -  Adequate organ function

        Exclusion Criteria:

          -  Currently participating and receiving study therapy or has participated in a study of
             an investigational agent and received study therapy or used an investigational device
             within 4 weeks of the first dose of study medication

          -  Has active autoimmune disease that has required systemic treatment within the 2 years
             prior to the first dose of study medication

          -  Diagnosis of immunodeficiency or receiving systemic steroid therapy or any other form
             of immunosuppressive therapy within 7 days prior to the first dose of study medication

          -  Known central nervous system (CNS) metastases and/or carcinomatous meningitis

          -  Prior anti-cancer mAb, chemotherapy, targeted small molecule therapy, or radiation
             therapy within 2 weeks prior to first dose of study medication or not recovered from
             adverse events due to a previously administered agent

          -  Prior therapy with an anti-PD-1, anti-PD-Ligand 1 (PD-L1), or anti-PD-L2 agent, or
             previously participated in a Merck pembrolizumab (MK-3475) study

          -  Has a known additional malignancy that has progressed or required active treatment
             within the last 5 years with the exception of basal cell carcinoma of the skin,
             squamous cell carcinoma of the skin that has undergone potentially curative therapy,
             in-situ cervical cancer, and in-situ or intra-mucosal pharyngeal cancer

          -  Received a live vaccine within 30 days of the first dose of study medication

          -  Known history of Human Immunodeficiency Virus (HIV) infection

          -  Known active Hepatitis B or C

          -  History of non-infectious pneumonitis that required steroids or current pneumonitis

          -  Active infection requiring systemic therapy

          -  Known psychiatric or substance abuse disorders that would interfere with cooperation
             with the requirements of the study

          -  Pregnant, breastfeeding, or expecting to conceive or father children within the
             projected duration of the study, starting with the screening visit through 120 days
             after the last dose of study medication