Study of First-line Treatment Patterns and Clinical Outcomes in Patients With Advanced Melanoma in the United Kingdom

NCT03448497 | Completed FDA Drug

• 1 other identifier: CA209-9TW
• Study Type: observational
• Target: 333
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to describe the first-line therapy landscape for patients with advanced melanoma and to describe clinical outcomes and healthcare resource utilization in a subset of treatment-naïve patients who initiated nivolumab + ipilimumab combination therapy.

Conditions

Melanoma

Outcome Measures

Primary Outcomes (1)

• Best Overall Response (BOR) rate

  In a subset of patients treated with first-line nivolumab + ipilimumab combination therapy

  Up to 18 months

Secondary Outcomes (14)

• Distribution of patient demographic characteristics

  At baseline

• Prior melanoma treatment history

  At baseline

• Serum concentration of lactate dehydrogenase (LDH)

  At baseline

• Eastern Cooperative Oncology Group (ECOG) score

  Up to 18 months

• Distribution of first-line treatment patterns

  Up to 18 months

Study Arms (1)

Advanced Melanoma patients who intiated first-line therapy

patients who initiated any first-line therapy for advanced melanoma and had not previously received treatment for their advanced disease

Other: Non-interventional

Interventions

Non-interventional OTHER

Non-interventional

Advanced Melanoma patients who intiated first-line therapy

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

The study population includes treatment-naïve patients with advanced (unresectable or metastatic) melanoma who initiated first-line therapy.

You may qualify if:

• Patient has medical chart documentation of advanced (unresectable or metastatic) melanoma.
• Patient initiated a first-line therapy for the treatment of advanced melanoma during the eligibility period (01 July 2016 to 01 July 2017; index event).
• Patient did not receive systemic treatment for their advanced (unresectable or metastatic) melanoma prior to index event
• Patient initiated first-line therapy at least six months before the date their chart abstraction initiated

You may not qualify if:

• Patient was enrolled in an investigational drug clinical trial or participating in medical research judged to directly affect how the patient was being monitored/treated while receiving first-line therapy
• Patient had another active concurrent malignancy other than advanced melanoma, which required systemic treatment at the time of index event
• Part or all of the patient's first-line treatment was received at a different site and the patient's medical chart pertaining to this care is not accessible
• Patient medical chart is missing, empty, or not retrievable

Sponsors & Collaborators

• Bristol-Myers Squibb: lead

Study Sites (1)

Local Institution

Cambridge, Cambridgeshire, CB16GQ, United Kingdom

Location

Related Links

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

MeSH Terms

Conditions

Melanoma

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: February 12, 2018
• First Posted: February 28, 2018
• Study Start: December 14, 2017
• Primary Completion: April 27, 2018
• Study Completion: April 27, 2018
• Last Updated: August 6, 2019

Record last verified: 2019-08

Locations

GB (1)