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

NCT05068609 | Completed

• 1 other identifier: CA209-7F9
• Study Type: observational
• Target: 509
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Squamous Cell Carcinoma of the Head and Neck

Keywords

BMS-936558; Health Related Quality of Life; Metastatic; Nivolumab; Opdivo®; Patient Reported Outcomes; Recurrent; Squamous Cell Carcinoma of the Head and Neck; VOLUME-PRO

Outcome Measures

Primary Outcomes (18)

• 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

Study Arms (1)

Cohort 1

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

Biological: Nivolumab

Interventions

Nivolumab BIOLOGICAL

Participants in this study are being treated with nivolumab for SCCHN

Also known as: Opdivo®, BMS-936558

Cohort 1

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The population for this study will be approximately 50 adult participants, with a diagnosis of recurrent or metastatic squamous cell carcinoma of the head and neck (SCCHN) currently being treated with nivolumab in the United Kingdom, Switzerland, Spain, or Canada. The study population will include participants with available data from medical records at enrollment who are willing to complete patient reported outcome (PRO) assessments.

You may qualify if:

• 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

You may not qualify if:

• Currently enrolled in an interventional clinical trial for their SCCHN
• Received systemic treatment for any other primary cancer within 6 months of study enrolment

Sponsors & Collaborators

• Bristol-Myers Squibb: lead

Study Sites (1)

Local Institution

Mount Laurel, New Jersey, 08054, United States

Location

Related Links

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

MeSH Terms

Conditions

Squamous Cell Carcinoma of Head and Neck; Neoplasm Metastasis; Recurrence

Interventions

Nivolumab

Condition Hierarchy (Ancestors)

Carcinoma, Squamous Cell; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Head and Neck Neoplasms; Neoplasms by Site; Neoplastic Processes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Disease Attributes

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Study Officials

• Bristol-Myers Squibb

  Bristol-Myers Squibb

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 8, 2021
• First Posted: October 6, 2021
• Study Start: August 13, 2020
• Primary Completion: October 18, 2021
• Study Completion: October 18, 2021
• Last Updated: May 5, 2022

Record last verified: 2022-05

Locations

US (1)