A Phase II study of Pembrolizumab in Previously Treated Subjects with Advanced/Metastatic Adenocarcinoma or Squamous Cell Carcinoma of the Esophagus

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 100

Inclusion Criteria

Subjects must:
- Be = 18 years of age on the day of signing the informed consent.
- Have an ECOG performance status of 0 or 1.
- Have a life expectancy greater than 3 months.
- Have histologically proven advanced/metastatic adenocarcinoma or squamous cell carcinoma of the esophagus or advanced/metastatic Siewert type 1 adenocarcinoma of the EGJ.
- Have experienced documented objective radiographic or clinical disease progression on two previous lines of Standard therapy. Third line subjects are defined as those who have progressed during or after receiving at least one dose of standard therapy given in a second line setting.
- Have measurable disease based on RECIST 1.1 as determined by central imaging vendor assessment.
- Provide either a newly obtained or archival tissue sample for intratumoral immune-related GEP and for PD-L1 by immunohistochemistry analysis. Newly-obtained tissue is preferred.
- Have demonstrated adequate organ function.
- Negative pregnancy test for females of child bearing potential prior to starting study and male and female subjects of childbearing potential must be willing to use an adequate method of contraception.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 50
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 50

Exclusion Criteria

The subject will be excluded from participating in the trial if the subject:
- Is currently participating and receiving study therapy or has participated in a study of an investigational agent and received study therapy or used an investigation device within 4 weeks of the first dose of treatment.
- Has an active autoimmune disease that has required systemic treatment in past 2 years.
- Has a diagnosis of immunodeficiency or is receiving systemic steroid therapy or any other form of immunosuppressive therapy within 7 days prior to the first dose of trial treatment.
- Has known active central nervous system (CNS) metastases and/or carcinomatous meningitis.
- Has received prior anti-cancer mAb, chemotherapy, targeted small molecule therapy, or radiation therapy within 2 weeks prior to first dose of trial Treatment or who has not recovered (i.e., = Grade 1 at baseline) from adverse events due to a previously administered agent.
- Has received prior therapy with an anti-PD-1, anti-PD-L1, or anti-PD-L2 agent or has previously participated in Merck pembrolizumab (MK-3475) clinical trials.
- Has a known additional malignancy that progressed or required active treatment within the last 5 years. Exceptions include 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 intramucosal pharyngeal cancer.
- Has received a live vaccine within 30 days of planned start of study therapy.
- Has a history or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the trial, interfere with the subject’s participation for the full duration of the trial, or is not in the best interest of the subject to participate, in the opinion of the treating investigator.
- Has a known history of Human Immunodeficiency Virus (HIV) infection.
- Has known active Hepatitis B (e.g., HBsAg reactive) or Hepatitis C (e.g., HCV RNA [qualitative] is detected).
- Has a history of (non-infectious) pneumonitis that required steroids or current pneumonitis.
- Has an active infection requiring systemic therapy.
- Has known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial.
- Is pregnant or breastfeeding, or expecting to conceive or father children within the projected duration of the trial, starting with the screening visit through 120 days after the last dose of trial treatment.

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method

Secondary Outcome Measures

Name	Time	Method

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