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

Overview

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 Type

  • Study Type: Observational
  • Study Design
    • Time Perspective: Retrospective
  • Study Primary Completion Date: October 30, 2017

Interventions

  • Other: Non-Interventional
    • Non-Interventional

Arms, Groups and Cohorts

  • 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
  • Ipi monotherapy
    • Part 2: patients must have been prescribed Ipi monotherapy during the index period between 01-Jan-2015 and 31-May-2016.
  • 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.
  • 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.
  • Pembro monotherapy
    • Part 2: patients must have been prescribed Pembro monotherapy during the index period between 01-Jan-2015 and 31-May-2016
  • Nivo monotherapy
    • Part 2: patients must have been prescribed Nivo monotherapy during the index period between 01-Jan-2015 and 31-May-2016

Clinical Trial Outcome Measures

Primary Measures

  • Distribution of treatment patterns for advanced melanoma patients
    • Time Frame: Aproximately 6 months
    • 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

Secondary Measures

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

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Bristol-Myers Squibb
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Bristol-Myers Squibb, Study Director, Bristol-Myers Squibb

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