Real-world Evaluation of the Impact of Baseline Metastases on Clinical Outcomes Among BRAF Positive Metastatic Melanoma Patients

This was a retrospective real-world evidence cohort study.

Study Overview

• Status: Completed
• Conditions: BRAF Positive Metastatic Melanoma

• Study Type: Observational
• Enrollment (Actual): 1961

Contacts and Locations

Study Locations

• United States
  • New Jersey
    • East Hanover, New Jersey, United States, 07936
      • Novartis

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

This was a retrospective, noninterventional cohort study

Description

Inclusion criteria:

• Diagnosis of melanoma (The International Classification of Diseases, 9th Revision [ICD-9] 172.x & 10th revision [ICD-10] C43 or D03x).
• Pathologic stage IV at initial diagnosis on or after 01 January 2011.
• First-line treatment with IO monotherapy or combination therapy (nivolumab, pembrolizumab, ipilimumab + nivolumab) or TT combination therapy (dabrafenib + trametinib, vemurafenib+cobimetinib, encorafenib+binimetinib) on or after 01 January 2014.
• Evidence of a BRAF test.
• Evidence of a BRAF-positive result prior to or up to 30 days after first-line (1L) therapy initiation.
• At least 18 years of age at the time of initiation of 1L treatment.

Exclusion criteria:

• Documented receipt of a clinical trial treatment for cancer at any time on or after 01 January 2014.
• Diagnosis of a second primary cancer or secondary cancer following initiation of 1L metastatic melanoma (MM) treatment.

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
Immunotherapy (IO) Cohort
Targeted Therapy (TT) Cohort

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Race		Baseline
Mean age		Baseline
Number of male patients		Baseline
Mean Charlson comorbidity index (CCI) score	Comorbidity was categorized into three grades: mild, with CCI scores of 1-2; moderate, with CCI scores of 3-4; and severe, with CCI scores ≥5.	Baseline
Eastern Cooperative Oncology Group performance status (ECOG PS)	The ECOG scale consists of 4 grades (from 0 to 4) where 0 implies fully active, and 4 implies completely disabled.	Baseline
Number of patients with study-related biomarkers	Study-related biomarkers included BRAF and PD1/PDL1 test dates and results.	Baseline
Number of metastatic sites		Baseline

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Progression-free survival (PFS)	PFS was defined as the time from the initiation of a line of therapy until the date of progression or death.	6 months and 1, 1.5, and 2 years
Overall survival (OS)	OS was defined as the time from the initiation of a line of therapy until death from any cause.	6 months and 1, 1.5, and 2 years

Collaborators and Investigators

• Sponsor: Novartis Pharmaceuticals
• Investigators: Study Director: Novartis Pharmaceuticals, Novartis Pharmaceuticals

Study record dates

Study Major Dates

• Study Start (Actual): June 8, 2022
• Primary Completion (Actual): August 24, 2022
• Study Completion (Actual): August 24, 2022

Study Registration Dates

• First Submitted: August 2, 2023
• First Submitted That Met QC Criteria: August 2, 2023
• First Posted (Actual): August 9, 2023

Study Record Updates

• Last Update Posted (Actual): August 9, 2023
• Last Update Submitted That Met QC Criteria: August 2, 2023
• Last Verified: August 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms by Histologic Type; Neoplasms; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms, Nerve Tissue; Neuroendocrine Tumors; Nevi and Melanomas; Melanoma
• Other Study ID Numbers: CTMT212AUS63