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

Bristol-Myers Squibb (BMS)

Status: Completed

Conditions: Melanoma

Treatments: Other: Non-Interventional

Study type: Observational

Funder types: Industry

Identifiers

NCT03199846

CA209-983

Details and patient eligibility

About

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).

Enrollment: 650 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

650 participants in 6 patient groups

advanced melanoma patients

Description:

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

Treatment:

Other: Non-Interventional

Ipi monotherapy

Description:

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

Treatment:

Other: Non-Interventional

Ipi + nivo combination therapy

Description:

Part 2: patients must have been prescribed Ipi + nivo combination therapy during the index period between 01-Jan-2015 and 31-May-2016.

Treatment:

Other: Non-Interventional

Dabrafenib + trametinib combination therapy

Description:

Part 2: patients must have been prescribed Dabrafenib + trametinib combination therapy during the index period between 01-Jan-2015 and 31-May-2016.

Treatment:

Other: Non-Interventional

Pembro monotherapy

Description:

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

Treatment:

Other: Non-Interventional

Nivo monotherapy

Description:

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

Treatment:

Other: Non-Interventional