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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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 |
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| Ipi monotherapy | Part 2: patients must have been prescribed Ipi monotherapy during the index period between 01-Jan-2015 and 31-May-2016. |
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| 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. |
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| 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. |
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| Pembro monotherapy | Part 2: patients must have been prescribed Pembro monotherapy during the index period between 01-Jan-2015 and 31-May-2016 |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Non-Interventional | Other | Non-Interventional |
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| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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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.
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| Name | Affiliation | Role |
|---|---|---|
| Bristol-Myers Squibb | Bristol-Myers Squibb | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Local Institution | Morristown | New Jersey | 07960 | United States |
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| ID | Term |
|---|---|
| D008545 | Melanoma |
| ID | Term |
|---|---|
| D018358 | Neuroendocrine Tumors |
| D017599 | Neuroectodermal Tumors |
| D009373 | Neoplasms, Germ Cell and Embryonal |
| D009370 | Neoplasms by Histologic Type |
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| Nivo monotherapy | Part 2: patients must have been prescribed Nivo monotherapy during the index period between 01-Jan-2015 and 31-May-2016 |
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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 |
| D009369 | Neoplasms |
| D009380 | Neoplasms, Nerve Tissue |
| D018326 | Nevi and Melanomas |
| D012878 | Skin Neoplasms |
| D009371 | Neoplasms by Site |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |