NCT05068609

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

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

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 509 (actual)
• Sponsor: Bristol-Myers Squibb · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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

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.

Conditions

• Squamous Cell Carcinoma of the Head and Neck

Interventions

Type	Name	Description
BIOLOGICAL	Nivolumab	Participants in this study are being treated with nivolumab for SCCHN

Timeline

• Start date: 2020-08-13
• Primary completion: 2021-10-18
• Completion: 2021-10-18
• First posted: 2021-10-06
• Last updated: 2022-05-05

Locations

1 site across 1 country: United States