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

Bristol-Myers Squibb (BMS)

Status: Completed

Conditions: Squamous Cell Carcinoma of the Head and Neck

Treatments: Biological: Nivolumab

Study type: Observational

Funder types: Industry

Identifiers

NCT05068609

CA209-7F9

Details and patient eligibility

About

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.

Full 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.

Enrollment: 509 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

509 participants in 1 patient group

Cohort 1

Description:

Participants with squamous cell carcinoma of the head and neck (SCCHN) treated with nivolumab

Treatment:

Biological: Nivolumab