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Completed

NCT Number: NCT05068609

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

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.

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Key information

Conditions

Squamous Cell Carcinoma of the Head and Neck Carcinoma Carcinoma, Squamous Cell Disease Attributes Head and Neck Neoplasms Neoplasm Metastasis Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Glandular and Epithelial Neoplastic Processes Pathologic Processes Pathological Conditions, Signs and Symptoms Recurrence Squamous Cell Carcinoma of Head and Neck

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Local Institution

Mount Laurel, New Jersey, 08054, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Nivolumab

Biological

Participants in this study are being treated with nivolumab for SCCHN

Other names: Opdivo®, BMS-936558

Primary outcomes

  1. Distribution of demographic characteristics of R/M SCCHN participants treated with nivolumab: Month and year of birth

    Time frame: At enrollment

    Recurrent/Metastatic (R/M) Squamous Cell Carcinoma of the Head & Neck (SCCHN)

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

    Time frame: At enrollment

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

    Time frame: At enrollment

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

    Time frame: At enrollment

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

    Time frame: At enrollment

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

    Time frame: At enrollment

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

    Time frame: At enrollment

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

    Time frame: At enrollment

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

    Time frame: At enrollment

  10. Distribution of patterns of use of nivolumab treatment in participants with R/M SCCHN: Duration of nivolumab therapy

    Time frame: Up to 8 weeks following enrollment

  11. Distribution of patterns of use of nivolumab treatment in participants with R/M SCCHN: Drug discontinuation

    Time frame: Up to 8 weeks following enrollment

  12. Distribution of doses of nivolumab therapy in participants with R/M SCCHN

    Time frame: Up to 8 weeks following enrollment

  13. Distribution of subsequent treatment in participants discontinuing nivolumab

    Time frame: Up to 8 weeks following enrollment

  14. 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

    Time frame: At enrollment, Up to 8 weeks

  15. Distribution of patient reported HRQoL measures through EQ-5D-5L in participants treated with nivolumab for R/M SCCHN

    Time frame: At enrollment, Up to 8 weeks

  16. 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

    Time frame: At enrollment, Up to 8 weeks

  17. Distribution of patient reported HRQoL measures through CTSQ in participants treated with nivolumab for R/M SCCHN

    Time frame: At enrollment, Up to 8 weeks

    Cancer Therapy Satisfaction Questionnaire (CTSQ)

  18. Distribution of patient reported HRQoL measures through WPAI:GH in participants treated with nivolumab for R/M SCCHN

    Time frame: At enrollment, Up to 8 weeks

    Work Productivity and Activity Impairment Questionnaire: General Health (WPAI:GH)

Sponsors and collaborators

Lead sponsor

Bristol-Myers Squibb

Industry

Registry information

Official study title

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

Acronym: VOLUME-PRO

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Oct 6, 2021
Registry last updated
May 5, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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