Long Term Quality of Life in Melanoma Patients in Netherlands

Bristol-Myers Squibb (BMS)

Status: Completed

Conditions: Melanoma

Treatments: Other: Non-Interventional

Study type: Observational

Funder types: Industry

Identifiers

NCT03450876

CA209-483

Details and patient eligibility

About

Study of late physical, psychological and social effects in patients treated with ipilimumab for advanced (stage IV or unresectable stage III) melanoma.

Enrollment: 89 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria-

• Patient population: Adults ≥ 18 years of age at diagnosis, diagnosed with histologically confirmed advanced (stage IV or unresectable stage III) melanoma, who have received at least one course of ipilimumab treatment (first, second, or second plus line; routine practice or study treatment) in one of the specified treatment centers, and who have survived at least 2 years after (completion of) ipilimumab treatment (measured from last ipilimumab administration)
• Matched healthy control population: Individuals without melanoma (stage III or IV) diagnosis that have been included in the PROFILES cohort

Exclusion Criteria

• Insufficient understanding of the Dutch language
• Other anticancer treatment after ipilimumab or during study entry
• Disease recurrence during the study

Other protocol defined inclusion/exclusion criteria could apply

Trial design

89 participants in 4 patient groups

Healthy Control

Description:

Individuals without melanoma (stage III or IV) diagnosis that have been included in the PROFILES cohort

Treatment:

Other: Non-Interventional

24 to < 36 months post-ipilimumab treatment

Description:

24 to 36 month post-ipilimumab treatment advanced melanoma patients that were treated with ipilimumab in 2014 in one of the 14 melanoma centers in the Netherlands

Treatment:

Other: Non-Interventional

≥ 36 to < 48 months post-ipilimumab treatment

Description:

36 to 48 month post-ipilimumab treatment advanced melanoma patients that were treated with ipilimumab in 2013 in one of the 14 melanoma centers in the Netherlands

Treatment:

Other: Non-Interventional

≥ 48 months post-ipilimumab treatment

Description:

Greater than 48 month post-ipilimumab treatment advanced melanoma patients that were treated with ipilimumab between 2011 and 2012 in one of the 14 melanoma centers in the Netherlands

Treatment:

Other: Non-Interventional