A Study of Nivolumab in Participants With Squamous Cell Carcinoma of the Head & Neck (SCCHN) - Patient Reported Outcomes (PRO)

Study Overview
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Brief Summary
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The purpose of the study is to capture the utilization of nivolumab among participants with squamous cell carcinoma of the head and neck (SCCHN) since its approval, and to describe the health related quality of life (HRQoL) among participants treated with nivolumab in a real-world setting.

Detailed Description
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This is a phase 4 prospective chart review study with patient reported outcome (PRO) administration. The study population consists of participants diagnosed with squamous cell carcinoma of the head and neck (SCCHN) and are being treated with nivolumab. Eligible participants will be enrolled and observed from enrollment up to eight weeks. Demographic and clinical characteristics will be collected at enrollment. PROs will be administered at enrollment and again at a follow-up standard of care visit approximately eight weeks after enrollment.

Official Title
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Nivolumab in the Real World in Patients With Squamous Cell Carcinoma of the Head & Neck (SCCHN) - Patient Reported Outcomes (PRO)

Conditions
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Squamous Cell Carcinoma of the Head and Neck

Intervention / Treatment
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* Biological: Nivolumab


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Diagnosis of recurrent/metastatic squamous cell carcinoma of the head and neck (SCCHN) Age ≥18 years at time of nivolumab treatment initiation Investigator has decided that nivolumab is appropriate therapy and the participant had received at least one administration of nivolumab for the treatment of recurrent/metastatic SCCHN prior to enrolment in the study Charts/records include treatment start date of nivolumab Provide consent and is willing to self-complete on-site patient reported outcomes (PROs) on at least one occasion Exclusion Criteria: Currently enrolled in an interventional clinical trial for their SCCHN Received systemic treatment for any other primary cancer within 6 months of study enrolment

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Cohort 1<br>Participants with squamous cell carcinoma of the head and neck (SCCHN) treated with nivolumab | Biological: Nivolumab<br>* Participants in this study are being treated with nivolumab for SCCHN<br>* Other names: Opdivo®, BMS-936558;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Distribution of demographic characteristics of R/M SCCHN participants treated with nivolumab: Month and year of birth | Recurrent/Metastatic (R/M) Squamous Cell Carcinoma of the Head & Neck (SCCHN) | At enrollment | 
| Distribution of demographic characteristics of R/M SCCHN participants treated with nivolumab: Sex |  | At enrollment | 
| Distribution of demographic characteristics of R/M SCCHN participants treated with nivolumab: Race/ethnicity |  | At enrollment | 
| Distribution of demographic characteristics of R/M SCCHN participants treated with nivolumab: Smoking status |  | At enrollment | 
| Distribution of clinical characteristics of R/M SCCHN participants treated with nivolumab: Primary tumor location |  | At enrollment | 
| Distribution of clinical characteristics of R/M SCCHN participants treated with nivolumab: Metastasis locations |  | At enrollment | 
| Distribution of clinical characteristics of R/M SCCHN participants treated with nivolumab: Histology |  | At enrollment | 
| Distribution of clinical characteristics of R/M SCCHN participants treated with nivolumab: Date of diagnosis of R/M SCCHN |  | At enrollment | 
| Distribution of clinical characteristics of R/M SCCHN participants treated with nivolumab: Stage at locally advanced/metastatic SCCHN diagnosis |  | At enrollment | 
| Distribution of patterns of use of nivolumab treatment in participants with R/M SCCHN: Duration of nivolumab therapy |  | Up to 8 weeks following enrollment | 
| Distribution of patterns of use of nivolumab treatment in participants with R/M SCCHN: Drug discontinuation |  | Up to 8 weeks following enrollment | 
| Distribution of doses of nivolumab therapy in participants with R/M SCCHN |  | Up to 8 weeks following enrollment | 
| Distribution of subsequent treatment in participants discontinuing nivolumab |  | Up to 8 weeks following enrollment | 
| Distribution of patient reported health-related quality of life (HRQoL) measures through European Organisation for Research and Treatment of Cancer Quality of Life- Core Questionnaire in participants treated with nivolumab for R/M SCCHN |  | At enrollment, Up to 8 weeks | 
| Distribution of patient reported HRQoL measures through EQ-5D-5L in participants treated with nivolumab for R/M SCCHN |  | At enrollment, Up to 8 weeks | 
| Distribution of patient reported HRQoL measures through European Organisation for Research and Treatment of Cancer Head and Neck Cancer Module in participants treated with nivolumab for R/M SCCHN |  | At enrollment, Up to 8 weeks | 
| Distribution of patient reported HRQoL measures through CTSQ in participants treated with nivolumab for R/M SCCHN | Cancer Therapy Satisfaction Questionnaire (CTSQ) | At enrollment, Up to 8 weeks | 
| Distribution of patient reported HRQoL measures through WPAI:GH in participants treated with nivolumab for R/M SCCHN | Work Productivity and Activity Impairment Questionnaire: General Health (WPAI:GH) | At enrollment, Up to 8 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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BMS-936558, Health Related Quality of Life, Metastatic, Nivolumab, Opdivo®, Patient Reported Outcomes, Recurrent, Squamous Cell Carcinoma of the Head and Neck, VOLUME-PRO