Study of Nivolumab in Unresectable Advanced or Recurrent Esophageal Cancer

Completed · Phase 3

Conditions studied: Esophageal Cancer

In brief

The purpose of study is to evaluate the efficacy and safety of Nivolumab in unresectable advanced or recurrent esophageal cancer patients who have failed in standard chemotherapies.

Key facts

Study ID

NCT02569242

Run by

Ono Pharmaceutical Co., Ltd.

People needed

419

Starts

2015-12-14

Expected to finish

2020-10-23

Last updated by the study team

2022-07-06

Who can join

Age: 20 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Men \& women ≥20 years of age
• Histologically confirmed unresectable advanced or recurrent esophageal cancer
• Refractory to or intolerant of standard therapy
• ECOG Performance Status score 0 or 1
• A life expectancy of at least 3 months

You may not qualify if…

• Current or past history of severe hypersensitivity to any other antibody products
• Patients with multiple primary cancers
• Patients with any metastasis in the brain or meninx that is symptomatic or requires treatment
• Patients with active, known or suspected autoimmune disease

Where it is running

• Georgetown University Med Ctr — Washington D.C., District of Columbia, United States
• Orlando Health, Inc — Orlando, Florida, United States
• Massachusetts General Hospital — Boston, Massachusetts, United States
• Duke Cancer Institute — Durham, North Carolina, United States
• Vanderbilt-Ingram Cancer Ctr — Nashville, Tennessee, United States
• The University Of Texas MD Anderson Cancer Center — Houston, Texas, United States
• Odense University Hospital — Odense C, Denmark
• RWTH Aachen University — Aachen, Germany
• Charite Campus Virchow Klinikum — Berlin, Germany
• University Hospital Heidelberg — Heidelberg, Germany
• Universitatsklinikum Jena, Innere Medizin II — Jena, Germany
• MVZ Mitte — Leipzig, Germany
• University Of Mainz Medical Center — Mainz, Germany
• Klinikum reechts der Isar, Technical University Munchen — Munich, Germany
• HPG23 — Bergamo, Italy
• Fondazione Irccs Istituto Nazionale Tumori — Milan, Italy
• Irccs Istituto Oncologico Veneto Iov — Padova, Italy
• Aichi Clinical Site — Nagoya, Aichi-ken, Japan
• Aichi Clinical Site — Nagoya, Aichi-ken, Japan
• Aomori Clinical Site — Hirosaki, Aomori, Japan
• Chiba Clinical Site — Kashiwa, Chiba, Japan
• Ehime Clinical Site — Matsuyama, Ehime, Japan
• Hokkaido Clinical Site — Sapporo, Hokkaido, Japan
• Hokkaido Clinical Site — Sapporo, Hokkaido, Japan
• Banner MD Anderson Cancer Center — Gilbert, Arizona, United States

Full record on ClinicalTrials.gov

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