Study of Nivolumab in Unresectable Advanced or Recurrent Esophageal Cancer

Phase 3

Completed

Brief Summary: 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.

Recruitment & Eligibility

Inclusion Criteria

Exclusion Criteria

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

Arm && Interventions

Group	Intervention	Description
Active Comparator Arm （Docetaxel/Paclitaxel）	Docetaxel/Paclitaxel	Docetaxel: Intravenously administered at a dose of 75 mg/m2 every 2 weeks until documented disease progression, discontinuation due to toxicity, withdrawal of consent or the study ends OR Paclitaxel: Intravenously administered at a dose of 100 mg/m2 weekly for 6 weeks followed by 2-week drug holiday until documented disease progression, discontinuation due to toxicity, withdrawal of consent or the study ends
Nivolumab Arm	Nivolumab	Nivolumab 240 mg/body solution intravenously every 2 weeks until documented disease progression, discontinuation due to toxicity, withdrawal of consent or the study ends

Primary Outcome Measures

Name	Time	Method
Overall Survival	("Date of death from any cause" - "Date of randomization" + 1) / 30.4375. For subjects lost to follow-up and subjects who are alive at the time of data cutoff date, data will be censored at the time the subject was last confirmed to be alive.

Secondary Outcome Measures

Name	Time	Method
Duration of Response	("Earlier date on which either the overall response was assessed as PD for the first time after confirmed response or the subject died of any cause" - "Date of first assessment of confirmed CR or PR" + 1) / 30.4375.	Please refer to the protocol, overall response and best overall response will be determined solely by imaging assessment according to the RECIST Guideline Version 1.1, and will not take into account any clinical/symptomatic progression. Evaluable imaging data will be overall response without an overall response of "Not Evaluable (NE)."
Progression-free Survival	("Earlier date on which either the overall response was assessed as PD or the subject died of any cause" - "Date of randomization" + 1) / 30.4375.	Please refer to the protocol, overall response and best overall response will be determined solely by imaging assessment according to the RECIST Guideline Version 1.1, and will not take into account any clinical/symptomatic progression. Evaluable imaging data will be overall response without an overall response of "Not Evaluable (NE)."

Locations (58): Banner MD Anderson Cancer Center
🇺🇸
Gilbert, Arizona, United States
Georgetown University Med Ctr
🇺🇸
Washington, 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
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Banner MD Anderson Cancer Center
🇺🇸Gilbert, Arizona, United States