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

Bristol-Myers Squibb (BMS)

Status: Completed

Conditions: Squamous Cell Carcinoma of the Head and Neck

Study type: Observational

Funder types: Industry

Identifiers

NCT05123950

CA209-8HX

Details and patient eligibility

About

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).

Enrollment: 304 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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).

Trial design

304 participants in 2 patient groups

Cohort 1

Description:

Participants diagnosed with R/M SCCHN between 01-Jan-2014 and 31-Dec-2016

Cohort 1- Augment

Description:

Participants newly initiating 1L treatment for R/M SCCHN between 01-Jun-2017 and 01-Jun-2018