Treatment Patterns and Outcomes Study in Patients With Unresectable Stage III and Metastatic (Stage IV) Melanoma in the United States

This study will collect real-world data from advanced melanoma diagnosis through most recent visit and data sourced from patient medical records following a 2-part study design consisting of a random sample (Part 1) and an oversample (Part 2).

Study Overview

• Status: Completed
• Conditions: Melanoma
• Intervention / Treatment: Other: Non-Interventional

• Study Type: Observational
• Enrollment (Actual): 650

Contacts and Locations

Study Locations

• United States
  • New Jersey
    • Morristown, New Jersey, United States, 07960
      • Local Institution

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients initiating a new line of therapy for unresectable stage III and/or metastatic (stage IV) melanoma during the index period between 01-Jan-2015 and 31-May-2016.

Description

Inclusion Criteria:

• Adults 18 years or older
• Diagnosis of unresectable stage III and/or metastatic (stage IV) melanoma before 01-Nov-2015
• Initiating a new line of therapy during the index period between 01-Jan-2015 and 31-May-2016, irrespective of advanced melanoma diagnosis date
• Medical history available for medical chart abstraction from date of diagnosis through most recent or current therapy (defined as end of data collection period)

Exclusion Criteria:

• Physicians unwilling or unable to follow study instructions
• Patients who were previously enrolled in a cancer treatment-related clinical trial since the diagnosis of unresectable stage III and/or metastatic (stage IV) melanoma

Study Plan

How is the study designed?

Number of groups / cohorts

6

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
advanced melanoma patients; Part 1 will consist of a representative sample of advanced melanoma patients, irrespective of date of diagnosis of stage III unresectable and metastatic/stage IV, to address information objectives on treatment patterns, clinical outcomes, and resource use after the start of treatment post-launch of new drugs, ie, since 2011 for ipi and 2015 for ipi + nivo in advanced melanoma	Other: Non-Interventional; Non-Interventional
Ipi monotherapy; Part 2: patients must have been prescribed Ipi monotherapy during the index period between 01-Jan-2015 and 31-May-2016.	Other: Non-Interventional; Non-Interventional
Ipi + nivo combination therapy; Part 2: patients must have been prescribed Ipi + nivo combination therapy during the index period between 01-Jan-2015 and 31-May-2016.	Other: Non-Interventional; Non-Interventional
Dabrafenib + trametinib combination therapy; Part 2: patients must have been prescribed Dabrafenib + trametinib combination therapy during the index period between 01-Jan-2015 and 31-May-2016.	Other: Non-Interventional; Non-Interventional
Pembro monotherapy; Part 2: patients must have been prescribed Pembro monotherapy during the index period between 01-Jan-2015 and 31-May-2016	Other: Non-Interventional; Non-Interventional
Nivo monotherapy; Part 2: patients must have been prescribed Nivo monotherapy during the index period between 01-Jan-2015 and 31-May-2016	Other: Non-Interventional; Non-Interventional

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Distribution of treatment patterns for advanced melanoma patients	Distribution of treatment patterns for advanced melanoma patients including, treatment regimen selection and rationale, as well as time to initiation of therapy and type of therapy	Aproximately 6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Distribution of prescribing patterns	Distribution of prescribing patterns by type of practice setting and melanoma patient volume	Approximately 16 months
Distribution of Patient Age at index date	Patient Age at index date will be determined from Medical Records	at baseline
Distribution of Patient's Sex at Index Date	Patient's sex will be determined from Medical Records	At Baseline
Distribution of Comorbidities at index date	Comorbidities will be determined using the Charlson Comorbidity Index (CCI)	At Baseline
Distribution of Healthcare Coverage type	Healthcare Coverage type will be determined using Medical Records	At Baseline
Distribution of Diagnosis Date	Melanoma Diagnosis Date will be determined using medical records	At Baseline
Distribution of Advanced Diagnosis Date	Date of advanced/ metastatic melanoma diagnosis will be determined using medical records	At Baseline
Distribution of Age at Onset	Diagnosis date-Date of Birth	At Baseline
Distribution of Disease stage at time of diagnosis	Disease stage at time of diagnosis will be determined using medical records	At Baseline
Distribution of Disease stage at subsequent visits	Disease stage at subsequent visits will be determined using medical records	Approximately 16 months
Distribution of ECOG status at Baseline	Eastern Cooperative Oncology Group (ECOG) status at Baseline will be determined using medical records	At Baseline
Distribution of ECOG status at Last Visit	Eastern Cooperative Oncology Group (ECOG) status at Last Visit will be determined using medical records	Approximately 16 months
Distribution of Biomarker status at baseline	Biomarker status will be determined using Medical Records	at baseline
Distribution of treatment-related adverse events	treatment-related adverse events will be determined using medical records	Approximately 16 months
Distribution of Overall Survival (OS) from Advanced Diagnosis	Date of death minus advanced/metastatic diagnosis date, censoring for LTF or end of observation	Approximately 16 months
Distribution of Progression-Free Survival (PFS) at Advanced Diagnosis	Date of progression (increase in tumor size or increase in cancer stage)/start of next line of therapy minus advanced/metastatic diagnosis date, censoring for LTF or end of observation	Approximately 16 months
Distribution of Overall Response Rate (ORR)		Approximately 16 months
Distribution of Overall Survival (OS) from Index Date	Date of death minus index treatment start date, censoring for LTF or end of observation	Approximately 16 months
Distribution of Progression-Free Survival (PFS) at Index Date	Date of progression (increase in tumor size or increase in cancer stage)/start of next line of therapy minus index treatment start date, censoring for LTF or end of observation	Approximately 16 months
Distribution of melanoma related HCRU		Approximately 16 months

Collaborators and Investigators

• Sponsor: Bristol-Myers Squibb

Study record dates

Study Major Dates

• Study Start (Actual): October 25, 2016
• Primary Completion (Actual): October 30, 2017
• Study Completion (Actual): December 31, 2017

Study Registration Dates

• First Submitted: June 23, 2017
• First Submitted That Met QC Criteria: June 23, 2017
• First Posted (Actual): June 27, 2017

Study Record Updates

• Last Update Posted (Actual): February 6, 2018
• Last Update Submitted That Met QC Criteria: February 5, 2018
• Last Verified: February 1, 2018

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: CA209-983