Gastric Cancer EMR100070-007

April 26, 2017

Sponsor: EMD Serono Research & Development Institute, Inc.

Number: EMR100070-007

The purpose of this study is to demonstrate superiority of treatment with Avelumab (an immunotherapy drug) versus continuation of first-line chemotherapy.

Who’s eligible:

  • The disease must be measurable by Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1). Subjects with histologically confirmed (tissue microscopically examined) unresectable locally advanced (cancer which has spread from the site of the primary (original) tumor only to surrounding tissue), or metastatic (the development of secondary malignant growths at a distance from a primary site of cancer) adenocarcinoma of the stomach or gastro-esophageal junction (GEJ) are eligible. The Eastern Cooperative Oncology Group Performance Status (ECOG PS) of 0 to 1 at trial entry. ECOG status is used by your doctor in order to assess how your disease is progressing, assess how the disease effects of your daily living abilities, and determine appropriate treatment and prognosis. The estimated life expectancy is more than 12 weeks for the patient.
  • The patient must have adequate hematological, hepatic (liver) and renal (kidney) functions defined by the protocol.
  • Negative blood pregnancy test at Screening for women of childbearing potential must be confirmed. Highly effective contraception for both male and female subjects if the risk of conception exists must be used.
  • This study is for patients age 18 and older.

Available at: Backus Hospital- Eastern Connecticut Hematology and Oncology.

Cancer Clinical Research Office