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American Family Children's Hospital

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Protocol No. UW17106

Principal Investigator Uboha, Nataliya

Phase I/II

Age Group Adult

Scope Local

Sponsor Type Industry; Institutional

Title Phase I/II Trial of Avelumab in Combination with Chemoradiation in the Treatment of Stage II/III Resectable Esophageal Cancer

Objective This study will be conducted in two parts. The purpose of the first part of the study will be to determine if the addition of avelumab to standard treatment before surgery for esophageal cancer and for a short period of time after surgery, is safe and does not produce any significant side effects. the purpose of the second part of this study will be to test the effectiveness of avelumab when added to standard treatment(that is, does it produce better results than standard treatment). Part II will also determine if the addition of avelumab to standard treatment is safe and does not produce any significant side effects.

Treatment Before surgery you will receive 5 sessions of chemotherapy with the drugs carboplatin and paciltaxel, you will also start radiation therapy treatment on the first day you start the chemotherapy. Then on day 29 you will receive avelumab every 2 weeks for a total of three treatments prior to surgery, Approximately 8 weeks after your last avelumab you will have surgery to reove the esophageal tumor. After your surgery about 2-3 weeks you will begin adjuvant treatment with avelumab for a total of 6 treatments every 2 weeks

Key Eligibility
  • Histologically confirmed, potentially curable squamous-cell carcinoma, adenocarcinoma, or large-cell undifferentiated carcinoma of the esophagus
  • Locoregional disease with clinical stage of T1N1 or T2-3N0-2
  • No clinical evidence of metastatic spread
  • Age 18 years or older
  • ECOG performance status 0-2
  • Subjects must be deemed to be potential surgical candidates by an evaluating surgeon
  • Adequate organ function
  • Male and female of child bearing potential must agree to use adequate birth control
  • Can not be pregnant or breast feeding
  • No prior history of radiation to the mediastinum
  • No Ddiagnosis of cervical esophageal carcinoma
  • No active or known autoimmune disease No active infection requiring systemic therapy
  • No prior organ transplantation including allogenic stem-cell transplantation
  • No known history of testing positive for HIV or known immunodeficiency syndrome
  • No Hepatitis B virus (HBV) or hepatitis C virus (HCV) infection at screening (positive HBV surface antigen or HCV RNA if anti-HCV antibody screening test positive)
  • No clinically significant (i.e., active) cardiovascular disease: cerebral vascular accident/stroke (< 6 months prior to enrollment), myocardial infarction (< 6 months prior to enrollment), unstable angina, congestive heart failure (≥ New York Heart Association Classification Class II), or serious cardiac arrhythmia requiring medication. Patients with stable rate-controlled atrial fibrillation will be allowed to participate
  • No other severe acute or chronic medical conditions including immune colitis, inflammatory bowel disease, immune pneumonitis, pulmonary fibrosis or psychiatric conditions

  • Applicable Disease Sites Esophagus

    Status Open

    Participating Institutions UW Hospital and Clinics