Clinical trial · Observational
A Study of Nivolumab in Participants With Squamous Cell Carcinoma of the Head & Neck (SCCHN) - Patient Reported Outcomes (PRO)
Nivolumab in the Real World in Patients With Squamous Cell Carcinoma of the Head & Neck (SCCHN) - Patient Reported Outcomes (PRO)
NCT05068609CI-TRIAL-00058294VOLUME-PROcompletedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Squamous Cell Carcinoma of the Head and Neck | Head and Neck Squamous Cell Carcinoma | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Nivolumab | Biological | Nivolumab | ALIAS |
Design
Arms and outcomes
Arms (1)
- label
- Cohort 1
- description
- Participants with squamous cell carcinoma of the head and neck (SCCHN) treated with nivolumab
- interventionNames
- Biological: Nivolumab
Primary outcomes (18)
- measure
- Distribution of demographic characteristics of R/M SCCHN participants treated with nivolumab: Month and year of birth
- timeFrame
- At enrollment
- description
- Recurrent/Metastatic (R/M) Squamous Cell Carcinoma of the Head \& Neck (SCCHN)
- 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
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.