Study of Nivolumab in Unresectable Advanced or Recurrent Esophageal Cancer

Study Overview
=================
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.

Official Title
-----------------
ONO-4538 Phase III Study A Multicenter, Randomized, Open-label Study in Patients With Esophageal Cancer Refractory or Intolerant to Combination Therapy With Fluoropyrimidine and Platinum-based Drugs

Conditions
-----------------
Esophageal Cancer

Intervention / Treatment
-----------------
* Drug: Nivolumab
* Drug: Docetaxel/Paclitaxel


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 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 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

Ages Eligible for Study
-----------------
Minimum Age: 20 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Nivolumab Arm<br>Nivolumab 240 mg/body solution intravenously every 2 weeks until documented disease progression, discontinuation due to toxicity, withdrawal of consent or the study ends | Drug: Nivolumab<br> <br> |
| Active Comparator: Active Comparator Arm （Docetaxel/Paclitaxel）<br>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 | Drug: Docetaxel/Paclitaxel<br> <br> |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Progression-free Survival | 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). | (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. | 
| Duration of Response | 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). | (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. |