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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03199846
Recruitment Status : Completed
First Posted : June 27, 2017
Last Update Posted : February 6, 2018
Sponsor:
Information provided by (Responsible Party):
Bristol-Myers Squibb

Brief Summary:
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).

Condition or disease Intervention/treatment
Melanoma Other: Non-Interventional

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Study Type : Observational
Actual Enrollment : 650 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Treatment Patterns and Outcomes Study in Patients With Unresectable Stage III and Metastatic (Stage IV) Melanoma in the United States
Actual Study Start Date : October 25, 2016
Actual Primary Completion Date : October 30, 2017
Actual Study Completion Date : December 31, 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Melanoma

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




Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. Distribution of prescribing patterns [ Time Frame: Approximately 16 months ]
    Distribution of prescribing patterns by type of practice setting and melanoma patient volume

  2. Distribution of Patient Age at index date [ Time Frame: at baseline ]
    Patient Age at index date will be determined from Medical Records

  3. Distribution of Patient's Sex at Index Date [ Time Frame: At Baseline ]
    Patient's sex will be determined from Medical Records

  4. Distribution of Comorbidities at index date [ Time Frame: At Baseline ]
    Comorbidities will be determined using the Charlson Comorbidity Index (CCI)

  5. Distribution of Healthcare Coverage type [ Time Frame: At Baseline ]
    Healthcare Coverage type will be determined using Medical Records

  6. Distribution of Diagnosis Date [ Time Frame: At Baseline ]
    Melanoma Diagnosis Date will be determined using medical records

  7. Distribution of Advanced Diagnosis Date [ Time Frame: At Baseline ]
    Date of advanced/ metastatic melanoma diagnosis will be determined using medical records

  8. Distribution of Age at Onset [ Time Frame: At Baseline ]
    Diagnosis date-Date of Birth

  9. Distribution of Disease stage at time of diagnosis [ Time Frame: At Baseline ]
    Disease stage at time of diagnosis will be determined using medical records

  10. Distribution of Disease stage at subsequent visits [ Time Frame: Approximately 16 months ]
    Disease stage at subsequent visits will be determined using medical records

  11. Distribution of ECOG status at Baseline [ Time Frame: At Baseline ]
    Eastern Cooperative Oncology Group (ECOG) status at Baseline will be determined using medical records

  12. 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

  13. Distribution of Biomarker status at baseline [ Time Frame: at baseline ]
    Biomarker status will be determined using Medical Records

  14. Distribution of treatment-related adverse events [ Time Frame: Approximately 16 months ]
    treatment-related adverse events will be determined using medical records

  15. 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

  16. 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

  17. Distribution of Overall Response Rate (ORR) [ Time Frame: Approximately 16 months ]
  18. 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

  19. 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

  20. Distribution of melanoma related HCRU [ Time Frame: Approximately 16 months ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03199846


Locations
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United States, New Jersey
Local Institution
Morristown, New Jersey, United States, 07960
Sponsors and Collaborators
Bristol-Myers Squibb
Investigators
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Study Director: Bristol-Myers Squibb Bristol-Myers Squibb

Additional Information:
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Responsible Party: Bristol-Myers Squibb
ClinicalTrials.gov Identifier: NCT03199846    
Other Study ID Numbers: CA209-983
First Posted: June 27, 2017    Key Record Dates
Last Update Posted: February 6, 2018
Last Verified: February 2018
Additional relevant MeSH terms:
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Melanoma
Neuroendocrine Tumors
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Nerve Tissue
Nevi and Melanomas
Trametinib
Dabrafenib
Antineoplastic Agents
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action