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

May 2, 2022 updated by: Bristol-Myers Squibb

Nivolumab in the Real World in Patients 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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Actual)

509

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • New Jersey
      • Mount Laurel, New Jersey, United States, 08054
        • Local Institution

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Cohort 1
Participants with squamous cell carcinoma of the head and neck (SCCHN) treated with nivolumab
Biological: Nivolumab
Participants in this study are being treated with nivolumab for SCCHN
Other Names:
  • Opdivo®, BMS-936558

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Bristol-Myers Squibb

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 13, 2020

Primary Completion (Actual)

October 18, 2021

Study Completion (Actual)

October 18, 2021

Study Registration Dates

First Submitted

September 8, 2021

First Submitted That Met QC Criteria

September 24, 2021

First Posted (Actual)

October 6, 2021

Study Record Updates

Last Update Posted (Actual)

May 5, 2022

Last Update Submitted That Met QC Criteria

May 2, 2022

Last Verified

May 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CA209-7F9

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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