Clinical trial NCT05068609: A Study of Nivolumab in Participants With Squamous Cell Carcinoma of the Head & Neck (SCCHN) - Patient Reported Outcomes (PRO)
Official title: Nivolumab in the Real World in Patients With Squamous Cell Carcinoma of the Head & Neck (SCCHN) - Patient Reported Outcomes (PRO)
Study type: OBSERVATIONAL
Overall status: COMPLETED
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
Lead sponsor: Bristol-Myers Squibb
Sponsor class: INDUSTRY
First posted: 2021-10-06
Enrollment: 509
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Distribution of demographic characteristics of R/M SCCHN participants treated with nivolumab: Month and year of birth
timeFrame: At enrollment
measure: Distribution of demographic characteristics of R/M SCCHN participants treated with nivolumab: Sex
timeFrame: At enrollment
measure: Distribution of demographic characteristics of R/M SCCHN participants treated with nivolumab: Race/ethnicity
timeFrame: At enrollment
measure: Distribution of demographic characteristics of R/M SCCHN participants treated with nivolumab: Smoking status
timeFrame: At enrollment
measure: Distribution of clinical characteristics of R/M SCCHN participants treated with nivolumab: Primary tumor location
timeFrame: At enrollment
measure: Distribution of clinical characteristics of R/M SCCHN participants treated with nivolumab: Metastasis locations
timeFrame: At enrollment
measure: Distribution of clinical characteristics of R/M SCCHN participants treated with nivolumab: Histology
timeFrame: At enrollment
measure: Distribution of clinical characteristics of R/M SCCHN participants treated with nivolumab: Date of diagnosis of R/M SCCHN
timeFrame: At enrollment
measure: Distribution of clinical characteristics of R/M SCCHN participants treated with nivolumab: Stage at locally advanced/metastatic SCCHN diagnosis
timeFrame: At enrollment
measure: Distribution of patterns of use of nivolumab treatment in participants with R/M SCCHN: Duration of nivolumab therapy
timeFrame: Up to 8 weeks following enrollment
measure: Distribution of patterns of use of nivolumab treatment in participants with R/M SCCHN: Drug discontinuation
timeFrame: Up to 8 weeks following enrollment
measure: Distribution of doses of nivolumab therapy in participants with R/M SCCHN
timeFrame: Up to 8 weeks following enrollment
measure: Distribution of subsequent treatment in participants discontinuing nivolumab
timeFrame: Up to 8 weeks following enrollment
measure: 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
timeFrame: At enrollment, Up to 8 weeks
measure: Distribution of patient reported HRQoL measures through EQ-5D-5L in participants treated with nivolumab for R/M SCCHN
timeFrame: At enrollment, Up to 8 weeks
measure: 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
timeFrame: At enrollment, Up to 8 weeks
measure: Distribution of patient reported HRQoL measures through CTSQ in participants treated with nivolumab for R/M SCCHN
timeFrame: At enrollment, Up to 8 weeks
measure: Distribution of patient reported HRQoL measures through WPAI:GH in participants treated with nivolumab for R/M SCCHN
timeFrame: At enrollment, Up to 8 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Mount Laurel
country: United States
facility: Local Institution
state: New Jersey
Study officials:
affiliation: Bristol-Myers Squibb
name: Bristol-Myers Squibb
role: STUDY_DIRECTOR
References: