Clinical trial · Observational
A Study of Treatment Patterns and Clinical Outcomes in First Line Recurrent/Metastatic Squamous Cell Carcinoma of the Head and Neck (1L R/M SCCHN) Participants in Europe
Treatment Patterns and Clinical Outcomes in First Line Recurrent/Metastatic Squamous Cell Carcinoma of the Head and Neck (1L R/M SCCHN) Patients in Europe
NCT05123950CI-TRIAL-00055082completedClinicalTrials.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 this observational study is to collect real-world data that describes treatment patterns and clinical outcomes in participants with first line recurrent/metastatic squamous cell carcinoma of the head \& neck (1L R/M SCCHN).
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 (0)
Data not yet available
No intervention recorded.
Design
Arms and outcomes
Arms (2)
- label
- Cohort 1
- description
- Participants diagnosed with R/M SCCHN between 01-Jan-2014 and 31-Dec-2016
- label
- Cohort 1- Augment
- description
- Participants newly initiating 1L treatment for R/M SCCHN between 01-Jun-2017 and 01-Jun-2018
Primary outcomes (45)
- measure
- Distribution of demographic characteristics of 1L R/M SCCHN participants treated with nivolumab: Age
- timeFrame
- At Baseline
- description
- Recurrent/Metastatic (R/M) Squamous Cell Carcinoma of the Head \& Neck (SCCHN)
- measure
- Distribution of demographic characteristics of 1L R/M SCCHN participants treated with nivolumab: Height
- timeFrame
- At Baseline
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
For more information regarding Bristol-Myers Squibb Clinical Trial participation, please visit www.BMSStudyConnect.com Inclusion Criteria: Participants are included in Cohort 1 - Augment if they meet the following criteria: * Adults18 years or older * Diagnosis of histologically confirmed R/M SCCHN, from any of the following primary sites only: oral cavity, oropharynx, hypopharynx, and larynx between 01-Jun-2017 and 31-June-2018. * Prescribed 1L treatment for R/M SCCHN * Treatment history and response available for medical chart abstraction from date of diagnosis until death or the end of the study in living participants * Have available for review one month of follow-up data available post initiation of 1L R/M SCCHN therapy * Informed consent form (ICF) signature/collection of living participants, as required by country regulation and local ethics committees Participants are included in Cohort 1 if they meet the following criteria: * Adults 18 years or older * Diagnosis of histologically confirmed R/M SCCHN, from any of the following primary sites only: oral cavity, oropharynx, hypopharynx and larynx between 01-Jan-2014 and 31-Dec-2016. * Prescribed 1L treatment for R/M SCCHN * Treatment history and response available for medical chart abstraction from the date of diagnosis until death or the end of the study in living participants * Have available for review one month of follow-up data post initiation of 1L R/M SCCHN therapy * Informed consent form (ICF) signature/collection of living participants, as required by country regulation and local ethics committees Exclusion Criteria: Participants were excluded from either cohort if they meet the following criteria: * Were enrolled in a cancer treatment-related clinical trial since the diagnosis of R/M SCCHN * Recurrent or metastatic carcinoma of the nasopharynx, squamous cell carcinoma of unknown primary site, squamous cell carcinoma that originated from the skin and salivary gland or non-squamous histologies (e.g., mucosal melanoma).
References
Publications (0)
Data not yet available
No reference posted for this study.