Conditions: Squamous Cell Carcinoma of the Head and Neck
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 361
Healthy volunteers: no

Brief summary:
The purpose of this study is to find out whether Nivolumab will significantly improve overall survival as compared to therapy of investigator's choice in patients with recurrent or metastatic head and neck carcinoma.

Detailed description:

Arms:
arm 1: Nivolumab 3mg/kg intravenous (IV) Solution for Injection every 2 weeks until disease progression arm 2: Cetuximab intravenous (IV) Solution for Injection 400 mg/m2 (first dose) then 250 mg/m2 weekly until disease progression

OR

Methotrexate intravenous (IV) Solution for Injection 40 or 60 mg/m2 weekly until disease progression

OR

Docetaxel intravenous (IV) Solution for Injection 30 or 40 mg/m2 weekly until disease progression

Interventions: intervention 1: Nivolumab intervention 2: Cetuximab intervention 3: Methotrexate intervention 4: Docetaxel
Intervention descriptions: intervention 1: None intervention 2: None intervention 3: None intervention 4: None

Protocol document: