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Completed

NCT Number: NCT05432622

A Study of Treatment Patterns and Outcomes in Participants With Stage IIIA Melanoma Receiving Adjuvant Systemic Therapy

The purpose of this study is to examine real-world data among participants with stage IIIa melanoma initiating nivolumab as adjuvant treatment in the community practice setting by utilizing patient data from the United States Oncology Network (USON) iKnowMed (iKM) electronic health records (EHR) database.

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Key information

Conditions

Melanoma Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Germ Cell and Embryonal Neoplasms, Nerve Tissue Neuroectodermal Tumors Neuroendocrine Tumors Nevi and Melanomas Parkinson Disease 4, Autosomal Dominant Lewy Body Skin Diseases Skin Neoplasms Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Local Institution

The Woodlands, Texas, 77380, United States

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Participants diagnosed with Stage IIIA melanoma during identification period
  • Participants underwent sentinel lymph node biopsy (SLNB) (index-event) during identification period
  • Participants with a complete surgical resection at or following SLNB during the identification period
  • Participants received nivolumab, pembrolizumab or dabrafenib/trametinib as adjuvant therapy in USON post-index event during the identification period (i.e., within 12 weeks of SLNB/resection); or received no treatment during the index period
  • Participants receiving care at a USON site utilizing the full EHR capacities of the iKM database at the time of treatment
  • Participants with ≥2 visits within the USON during the observation period
  • Participants ≥18 years of age at first clinical diagnosis of melanoma

Exclusion criteria

  • Participants with a previous systemic therapy prior to index
  • Participants with a diagnosis of ocular or uveal melanoma during the study period
  • Participants with a previous nonmelanoma cancer without complete remission for more than 3 years prior to index
  • Participants with mucosal or acral melanoma during the study period
  • Participants with systemic use of glucocorticoids during at the initiation of adjuvant therapy
  • Participants enrolled in a clinical trial at any time during the study period
  • Participants with a diagnosis and receiving treatment for another malignancy during the study observation period

Treatment and study plan

Primary outcomes

  1. Time to Treatment Discontinuation (TTD)

    Time frame: Up to 39 Months

  2. Recurrence-free Survival (RFS)

    Time frame: Up to 39 Months

Secondary outcomes

  1. Number of Participants with Treatment-related Adverse Events (AEs)

    Time frame: Up to 39 Months

  2. Time to Next Treatment (TTNT)

    Time frame: Up to 39 Months

  3. Number of Participants with Treatment-Related Hospitalizations

    Time frame: Up to 39 Months

  4. Number of Participants with Emergency Department Visits

    Time frame: Up to 39 Months

  5. Overall Survival (OS)

    Time frame: Up to 39 Months

Sponsors and collaborators

Lead sponsor

Bristol-Myers Squibb

Industry

Registry information

Official study title

Treatment Patterns and Outcomes for Patients With Stage IIIA Melanoma Receiving Adjuvant Systemic Therapy in the US Community Oncology Setting

Important dates

Study start
2019
Primary completion
2023
Study completion
2023
First posted
Jun 27, 2022
Registry last updated
Jan 18, 2024

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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