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

NCT05432622 | Completed

• 1 other identifier: CA209-7PG
• Study Type: observational
• Target: 95
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Melanoma

Keywords

Anti-programmed cell death protein 1 (PD-1); Watchful waiting

Outcome Measures

Primary Outcomes (2)

• Time to Treatment Discontinuation (TTD)

  Up to 39 Months

• Recurrence-free Survival (RFS)

  Up to 39 Months

Secondary Outcomes (5)

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

  Up to 39 Months

• Time to Next Treatment (TTNT)

  Up to 39 Months

• Number of Participants with Treatment-Related Hospitalizations

  Up to 39 Months

• Number of Participants with Emergency Department Visits

  Up to 39 Months

• Overall Survival (OS)

  Up to 39 Months

Study Arms (4)

Nivolumab Monotherapy

Participants who started adjuvant nivolumab

Pembrolizumab Monotherapy

Participants who started adjuvant pembrolizumab

Dabrafenib + Trametinib Combination Therapy

Participants who started adjuvant dabrafenib + trametinib combination therapy

No Treatment of a Systemic Therapy

Participants with no systemic treatment during the study observation period until record of recurrence

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Adult participants diagnosed with stage IIIA melanoma receiving an adjuvant systemic treatment regimen in the USON iKM EHR database were identified.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Bristol-Myers Squibb: lead

Study Sites (1)

Local Institution

The Woodlands, Texas, 77380, United States

Location

Related Links

• BMS Clinical Trial Information
• FDA Safety Alerts and Recalls
• Investigator Inquiry Form

MeSH Terms

Conditions

Melanoma; Parkinson Disease 4, Autosomal Dominant Lewy Body

Condition Hierarchy (Ancestors)

Neuroendocrine Tumors; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Nerve Tissue; Nevi and Melanomas; Skin Neoplasms; Neoplasms by Site; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Bristol-Myers Squibb

  Bristol-Myers Squibb

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 21, 2022
• First Posted: June 27, 2022
• Study Start: December 19, 2019
• Primary Completion: April 26, 2023
• Study Completion: July 11, 2023
• Last Updated: January 18, 2024

Record last verified: 2024-01

Locations

US (1)