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

Squamous Cell Carcinoma of the Head and Neck Clinical Trial

— VOLUME-PRO  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05068609
• Other study ID #: CA209-7F9
• Status: Completed
• Start date: August 13, 2020
• Est. completion date: October 18, 2021

Study information

• Verified date: May 2022
• Source: Bristol-Myers Squibb
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 509
• Est. completion date: October 18, 2021
• Est. primary completion date: October 18, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Carcinoma
• Carcinoma, Squamous Cell
• Squamous Cell Carcinoma of Head and Neck
• Squamous Cell Carcinoma of the Head and Neck

Intervention

Biological:
• Nivolumab
Participants in this study are being treated with nivolumab for SCCHN

Locations

Country	Name	City	State
United States	Local Institution	Mount Laurel	New Jersey

Sponsors (1)

Lead Sponsor	Collaborator
Bristol-Myers Squibb

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	Distribution of demographic characteristics of R/M SCCHN participants treated with nivolumab: Sex		At enrollment
Primary	Distribution of demographic characteristics of R/M SCCHN participants treated with nivolumab: Race/ethnicity		At enrollment
Primary	Distribution of demographic characteristics of R/M SCCHN participants treated with nivolumab: Smoking status		At enrollment
Primary	Distribution of clinical characteristics of R/M SCCHN participants treated with nivolumab: Primary tumor location		At enrollment
Primary	Distribution of clinical characteristics of R/M SCCHN participants treated with nivolumab: Metastasis locations		At enrollment
Primary	Distribution of clinical characteristics of R/M SCCHN participants treated with nivolumab: Histology		At enrollment
Primary	Distribution of clinical characteristics of R/M SCCHN participants treated with nivolumab: Date of diagnosis of R/M SCCHN		At enrollment
Primary	Distribution of clinical characteristics of R/M SCCHN participants treated with nivolumab: Stage at locally advanced/metastatic SCCHN diagnosis		At enrollment
Primary	Distribution of patterns of use of nivolumab treatment in participants with R/M SCCHN: Duration of nivolumab therapy		Up to 8 weeks following enrollment
Primary	Distribution of patterns of use of nivolumab treatment in participants with R/M SCCHN: Drug discontinuation		Up to 8 weeks following enrollment
Primary	Distribution of doses of nivolumab therapy in participants with R/M SCCHN		Up to 8 weeks following enrollment
Primary	Distribution of subsequent treatment in participants discontinuing nivolumab		Up to 8 weeks following enrollment
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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

External Links

•   BMS Clinical Trial Information
•   BMS Clinical Trial Patient Recruiting
•   FDA Safety Alerts and Recalls
•   Investigator Inquiry Form