An observational study in Melanoma, sponsored by Bristol-Myers Squibb. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2018-02-06.
Sponsored by Bristol-Myers Squibb · Observational
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).
3,006 studies on the registry are indexed under Melanoma; 520 are open to participants now.
This study's enrollment of 650 is above the median of 182 across 438 observational studies indexed under Melanoma.
Browse Melanoma studies →Bristol-Myers Squibb is the lead sponsor of 1,538 studies on the registry; 116 are open to participants now.
Of its 429 completed or terminated interventional studies of FDA-regulated products, 223 (52%) have results posted.
Counted across the registry records on this site, refreshed daily.
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.
Exclusion Criteria:
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
Part 2: patients must have been prescribed Ipi monotherapy during the index period between 01-Jan-2015 and 31-May-2016.
Other: Non-Interventional
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
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
Part 2: patients must have been prescribed Pembro monotherapy during the index period between 01-Jan-2015 and 31-May-2016
Other: Non-Interventional
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
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
Time frame: Aproximately 6 months
Distribution of prescribing patterns
Distribution of prescribing patterns by type of practice setting and melanoma patient volume
Time frame: Approximately 16 months
Distribution of Patient Age at index date
Patient Age at index date will be determined from Medical Records
Time frame: at baseline
Distribution of Patient's Sex at Index Date
Patient's sex will be determined from Medical Records
Time frame: At Baseline
Distribution of Comorbidities at index date
Comorbidities will be determined using the Charlson Comorbidity Index (CCI)
Time frame: At Baseline
Distribution of Healthcare Coverage type
Healthcare Coverage type will be determined using Medical Records
Time frame: At Baseline
Distribution of Diagnosis Date
Melanoma Diagnosis Date will be determined using medical records
Time frame: At Baseline
Distribution of Advanced Diagnosis Date
Date of advanced/ metastatic melanoma diagnosis will be determined using medical records
Time frame: At Baseline
Distribution of Age at Onset
Diagnosis date-Date of Birth
Time frame: At Baseline
Distribution of Disease stage at time of diagnosis
Disease stage at time of diagnosis will be determined using medical records
Time frame: At Baseline
Distribution of Disease stage at subsequent visits
Disease stage at subsequent visits will be determined using medical records
Time frame: Approximately 16 months
Distribution of ECOG status at Baseline
Eastern Cooperative Oncology Group (ECOG) status at Baseline will be determined using medical records
Time frame: At Baseline
Distribution of ECOG status at Last Visit
Eastern Cooperative Oncology Group (ECOG) status at Last Visit will be determined using medical records
Time frame: Approximately 16 months
Distribution of Biomarker status at baseline
Biomarker status will be determined using Medical Records
Time frame: at baseline
Distribution of treatment-related adverse events
treatment-related adverse events will be determined using medical records
Time frame: 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
Time frame: 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
Time frame: Approximately 16 months
Distribution of Overall Response Rate (ORR)
Time frame: 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
Time frame: 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
Time frame: Approximately 16 months
Distribution of melanoma related HCRU
Time frame: Approximately 16 months
This study is completed, as verified in Feb 2018. You cannot join it, but the record below documents what was studied.
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Bristol-Myers Squibb