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
Overview
- Phase
- Phase 3
- Intervention
- Nivolumab
- Conditions
- Esophageal Cancer
- Sponsor
- Ono Pharmaceutical Co. Ltd
- Enrollment
- 419
- Locations
- 58
- Primary Endpoint
- Overall Survival
- Status
- Completed
- Last Updated
- 3 years ago
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.
Investigators
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
Arms & Interventions
Nivolumab Arm
Nivolumab 240 mg/body solution intravenously every 2 weeks until documented disease progression, discontinuation due to toxicity, withdrawal of consent or the study ends
Intervention: Nivolumab
Active Comparator Arm （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
Intervention: Docetaxel/Paclitaxel
Outcomes
Primary Outcomes
Overall Survival
Time Frame: ("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 Outcomes
- 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.)
- 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.)