Study of Nivolumab in Unresectable Advanced or Recurrent Esophageal Cancer

Ono Pharmaceuticals

Status and phase: Completed; Phase 3

Conditions: Esophageal Cancer

Treatments: Drug: Nivolumab; Drug: Docetaxel/Paclitaxel

Study type: Interventional

Funder types: Industry

Identifiers

NCT02569242

ONO-4538-24/CA209-473

Details and patient eligibility

About

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.

Enrollment: 419 patients

Sex: All

Ages: 20+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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419 participants in 2 patient groups

Nivolumab Arm

Experimental group

Description:

Nivolumab 240 mg/body solution intravenously every 2 weeks until documented disease progression, discontinuation due to toxicity, withdrawal of consent or the study ends

Treatment:

Drug: Nivolumab

Active Comparator Arm （Docetaxel/Paclitaxel）

Active Comparator group

Description:

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

Treatment:

Drug: Docetaxel/Paclitaxel