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

Bristol-Myers Squibb509 enrolled

Overview

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.

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.

Study Type

OBSERVATIONAL

Enrollment

509

Conditions

Squamous Cell Carcinoma of the Head and Neck

Interventions

NivolumabBIOLOGICAL

Participants in this study are being treated with nivolumab for SCCHN

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

Local Institution

Mount Laurel, New Jersey, United States

Outcomes

Primary Outcomes

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)

Time frame: At enrollment

Distribution of demographic characteristics of R/M SCCHN participants treated with nivolumab: Sex

Time frame: At enrollment

Distribution of demographic characteristics of R/M SCCHN participants treated with nivolumab: Race/ethnicity

Time frame: At enrollment

Distribution of demographic characteristics of R/M SCCHN participants treated with nivolumab: Smoking status

Time frame: At enrollment

Distribution of clinical characteristics of R/M SCCHN participants treated with nivolumab: Primary tumor location

Time frame: At enrollment

Distribution of clinical characteristics of R/M SCCHN participants treated with nivolumab: Metastasis locations

Time frame: At enrollment

Distribution of clinical characteristics of R/M SCCHN participants treated with nivolumab: Histology

Time frame: At enrollment

Distribution of clinical characteristics of R/M SCCHN participants treated with nivolumab: Date of diagnosis of R/M SCCHN

Time frame: At enrollment

Distribution of clinical characteristics of R/M SCCHN participants treated with nivolumab: Stage at locally advanced/metastatic SCCHN diagnosis

Time frame: At enrollment

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.