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Completed

NCT Number: NCT05123950

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

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).

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Key information

Conditions

Squamous Cell Carcinoma of the Head and Neck Carcinoma Carcinoma, Squamous Cell Disease Attributes Head and Neck Neoplasms Neoplasm Metastasis Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Glandular and Epithelial Neoplastic Processes Pathologic Processes Pathological Conditions, Signs and Symptoms Recurrence Squamous Cell Carcinoma of Head and Neck

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Medical Data Analytics

Parsippany, New Jersey, 07054, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

Primary outcomes

  1. Distribution of demographic characteristics of 1L R/M SCCHN participants treated with nivolumab: Age

    Time frame: At Baseline

    Recurrent/Metastatic (R/M) Squamous Cell Carcinoma of the Head & Neck (SCCHN)

  2. Distribution of demographic characteristics of 1L R/M SCCHN participants treated with nivolumab: Height

    Time frame: At Baseline

  3. Distribution of demographic characteristics of 1L R/M SCCHN participants treated with nivolumab: Weight

    Time frame: At Baseline

  4. Distribution of demographic characteristics of 1L R/M SCCHN participants treated with nivolumab: Body surface area (BSA)

    Time frame: At Baseline

  5. Distribution of demographic characteristics of 1L R/M SCCHN participants treated with nivolumab: Health insurance coverage

    Time frame: At Baseline

  6. Distribution of demographic characteristics of 1L R/M SCCHN participants treated with nivolumab: Tobacco use

    Time frame: At Baseline

  7. Distribution of demographic characteristics of 1L R/M SCCHN participants treated with nivolumab: Patient comorbidities

    Time frame: At Baseline

  8. Distribution of demographic characteristics of 1L R/M SCCHN participants treated with nivolumab: Alcohol use

    Time frame: At Baseline

  9. Distribution of clinical characteristics of 1L R/M SCCHN participants treated with nivolumab: Human papillomavirus(HPV) p -16 status

    Time frame: At Baseline

  10. Distribution of clinical characteristics of 1L R/M SCCHN participants treated with nivolumab: Date of early stage diagnosis

    Time frame: At Baseline

  11. Distribution of clinical characteristics of 1L R/M SCCHN participants treated with nivolumab: Receive a platinum-based agent for early stage diagnosis

    Time frame: At Baseline

  12. Distribution of clinical characteristics of 1L R/M SCCHN participants treated with nivolumab: Receive radiation within 6 months prior to early stage diagnosis

    Time frame: At Baseline

  13. Distribution of clinical characteristics of 1L R/M SCCHN participants treated with nivolumab: Undergo related surgeries within 6 months prior to early stage diagnosis

    Time frame: At Baseline

  14. Distribution of clinical characteristics of 1L R/M SCCHN participants treated with nivolumab: Date of R/M SCCHN diagnosis

    Time frame: At Baseline

  15. Distribution of clinical characteristics of 1L R/M SCCHN participants treated with nivolumab: Specialty of diagnosing physician

    Time frame: At Baseline

  16. Distribution of clinical characteristics of 1L R/M SCCHN participants treated with nivolumab: Primary site of SCCHN at R/M diagnosis

    Time frame: At Baseline

  17. Distribution of clinical characteristics of 1L R/M SCCHN participants treated with nivolumab: Clinical stage at R/M diagnosis

    Time frame: At Baseline

  18. Distribution of clinical characteristics of 1L R/M SCCHN participants treated with nivolumab: Primary tumor stage at R/M diagnosis

    Time frame: At Baseline

  19. Distribution of clinical characteristics of 1L R/M SCCHN participants treated with nivolumab: Lymph node involvement at R/M diagnosis

    Time frame: At Baseline

  20. Distribution of clinical characteristics of 1L R/M SCCHN participants treated with nivolumab: Metastasis at R/M diagnosis

    Time frame: At Baseline

  21. Distribution of clinical characteristics of 1L R/M SCCHN participants treated with nivolumab: Histologic tumor grade at R/M diagnosis

    Time frame: At Baseline

  22. Distribution of clinical characteristics of 1L R/M SCCHN participants treated with nivolumab: Overall prognosis at R/M diagnosis

    Time frame: At Baseline

  23. Distribution of clinical characteristics of 1L R/M SCCHN participants treated with nivolumab: Platinum-based grouping

    Time frame: At Baseline

  24. Distribution of diagnostic procedures of 1L R/M SCCHN participants treated with nivolumab

    Time frame: At Baseline

  25. Distribution of treatment patterns of 1L R/M SCCHN participants treated with nivolumab: First (second, third+) Line of therapy (LOT)

    Time frame: At Baseline

  26. Distribution of treatment patterns of 1L R/M SCCHN participants treated with nivolumab: Duration of LOT

    Time frame: At Baseline

  27. Distribution of treatment patterns of 1L R/M SCCHN participants treated with nivolumab: Administration form

    Time frame: At Baseline

  28. Distribution of treatment patterns of 1L R/M SCCHN participants treated with nivolumab: Dose

    Time frame: At Baseline

  29. Distribution of treatment patterns of 1L R/M SCCHN participants treated with nivolumab: Dose changes

    Time frame: At Baseline

  30. Distribution of treatment patterns of 1L R/M SCCHN participants treated with nivolumab: Frequency of treatment regimen

    Time frame: At Baseline

  31. Distribution of treatment patterns of 1L R/M SCCHN participants treated with nivolumab: Schedule of agent administration

    Time frame: At Baseline

  32. Distribution of treatment patterns of 1L R/M SCCHN participants treated with nivolumab: Number of planned cycles

    Time frame: At Baseline

  33. Distribution of treatment patterns of 1L R/M SCCHN participants treated with nivolumab: Number of completed cycles

    Time frame: At Baseline

  34. Distribution of treatment patterns of 1L R/M SCCHN participants treated with nivolumab: Reasons for prescribing therapy

    Time frame: At Baseline

  35. Distribution of treatment patterns of 1L R/M SCCHN participants treated with nivolumab: Reasons for discontinuing therapy

    Time frame: At Baseline

  36. Distribution of treatment patterns of 1L R/M SCCHN participants treated with nivolumab: Dose delays

    Time frame: At Baseline

  37. Distribution of treatment patterns of 1L R/M SCCHN participants treated with nivolumab: Radiation performed for R/M disease

    Time frame: At Baseline

  38. Distribution of treatment patterns of 1L R/M SCCHN participants treated with nivolumab: Surgical procedures performed for R/M disease

    Time frame: At Baseline

  39. Distribution of adverse events of 1L R/M SCCHN participants treated with nivolumab

    Time frame: At Baseline

  40. Distribution of adverse events of 1L R/M SCCHN participants treated with nivolumab: Action taken

    Time frame: At Baseline

  41. Distribution of adverse events of 1L R/M SCCHN participants treated with nivolumab: Resolution

    Time frame: At Baseline

  42. Distribution of clinical outcomes of 1L R/M SCCHN participants treated with nivolumab: Response to therapy

    Time frame: At Baseline

  43. Distribution of clinical outcomes of 1L R/M SCCHN participants treated with nivolumab: Duration of response

    Time frame: Up to approximately 36 months

  44. Distribution of clinical outcomes of 1L R/M SCCHN participants treated with nivolumab: Overall survival

    Time frame: Up to approximately 36 months

  45. Distribution of clinical outcomes of 1L R/M SCCHN participants treated with nivolumab: Progression free survival

    Time frame: Up to approximately 36 months

Secondary outcomes

  1. Comparison of patient demographics, clinical characteristics, and treatment patterns between the Cohort 1- Augment and Cohort 1

    Time frame: At Baseline

  2. Comparison of time to event endpoints of OS, PFS, and DOR between Cohort 1- Augment and Cohort 1

    Time frame: Up to approximately 36 months

Sponsors and collaborators

Lead sponsor

Bristol-Myers Squibb

Industry

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2021
Study completion
2021
First posted
Nov 17, 2021
Registry last updated
Nov 17, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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