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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

Tracking Information
First Submitted Date June 23, 2017
First Posted Date June 27, 2017
Last Update Posted Date February 6, 2018
Actual Study Start Date October 25, 2016
Actual Primary Completion Date October 30, 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: June 23, 2017)
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
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures
 (submitted: June 23, 2017)
  • 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 ]
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Treatment Patterns and Outcomes Study in Patients With Unresectable Stage III and Metastatic (Stage IV) Melanoma in the United States
Official Title Treatment Patterns and Outcomes Study in Patients With Unresectable Stage III and Metastatic (Stage IV) Melanoma in the United States
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).
Detailed Description Not Provided
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Retrospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
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.
Condition Melanoma
Intervention Other: Non-Interventional
Non-Interventional
Study Groups/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
    Intervention: Other: 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.
    Intervention: Other: 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.
    Intervention: Other: 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.
    Intervention: Other: 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
    Intervention: Other: 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
    Intervention: Other: Non-Interventional
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: June 23, 2017)
650
Original Estimated Enrollment Same as current
Actual Study Completion Date December 31, 2017
Actual Primary Completion Date October 30, 2017   (Final data collection date for primary outcome measure)
Eligibility 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
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT03199846
Other Study ID Numbers CA209-983
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Bristol-Myers Squibb
Study Sponsor Bristol-Myers Squibb
Collaborators Not Provided
Investigators
Study Director: Bristol-Myers Squibb Bristol-Myers Squibb
PRS Account Bristol-Myers Squibb
Verification Date February 2018