study of pembrolizumab (mk-3475) in previously-treated participants with advanced carcinoma of the esophagus or esophagogastric junction (mk-3475-180/keynote-180)

Conditions: Esophageal Carcinoma; Esophagogastric Junction Carcinoma

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

Keywords: programmed cell death-1 (pd-1, pd1) programmed cell death-ligand 1 (pd-l1, pdl1) programmed cell death-ligand 2 (pd-l2, pdl2)