An Open Label, Randomized Phase 3 Clinical Trial of Nivolumab vs Therapy of Investigator's Choice in Recurrent or Metastatic Platinum-refractory Squamous Cell Carcinoma of the Head and Neck (SCCHN)
Trial Snapshot
- Phase
- Phase 3
- Status
- Completed
- Sponsor
- Enrollment
- 361
- Locations
- 47
- Primary Endpoint
- Overall Survival (OS)
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Men and women ≥ 18 years of age with an Eastern Cooperative Oncology Group (ECOG) performance status ≤ 1
- •Histologically confirmed recurrent or metastatic SCCHN (oral cavity, pharynx, larynx), stage III/IV and not amenable to local therapy with curative intent (surgery or radiation therapy with or without chemotherapy)
- •Tumor progression or recurrence within 6 months of last dose of platinum therapy in the adjuvant (ie with radiation after surgery), primary (ie, with radiation), recurrent, or metastatic setting
- •Measurable disease by Computed tomography (CT) or Magnetic resonance imaging (MRI) per Response Evaluation Criteria In Solid Tumors (RECIST 1.1) criteria
Exclusion Criteria
- •Active brain metastases or leptomeningeal metastases are not allowed
- •Histologically confirmed recurrent or metastatic carcinoma of the nasopharynx, squamous cell carcinoma of unknown primary, and salivary gland or non-squamous histologies (eg: mucosal melanoma) are not allowed
- •Subjects with active, known or suspected autoimmune disease
Arms & Interventions
Arm A: Nivolumab
Nivolumab 3mg/kg intravenous (IV) Solution for Injection every 2 weeks until disease progression
Intervention: Nivolumab (Drug)
Arm B: Cetuximab/Methotrexate/Docetaxel
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
Intervention: Cetuximab (Drug)
Arm B: Cetuximab/Methotrexate/Docetaxel
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
Intervention: Methotrexate (Drug)
Arm B: Cetuximab/Methotrexate/Docetaxel
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
Intervention: Docetaxel (Drug)
Outcomes
Primary Outcomes
Overall Survival (OS)
Time Frame: From date of randomization to date of death (Up to approximately 18 months)
OS was defined as the time from randomization to the date of death from any cause. Participants were censored at the date they were last known to be alive and at the date of randomization if they were randomized but had no follow-up. Median OS time was calculated using Kaplan-Meier (KM) method.
Secondary Outcomes
- Investigator-Assessed Progression-Free Survival (PFS)(From date of randomization to date of disease progression or death, whichever occurs first (Up to approximately 87 months))
- Investigator-Assessed Objective Response Rate (ORR)(From date of randomization to date of disease progression or study drug is discontinued, whichever occurs first (Up to approximately 87 months))