After the introduction of ipilimumab, an anti-CTLA-4 monoclonal antibody, durable, long term survival has become a possibility for a subgroup of advanced melanoma patients. Since ipilimumab is a relatively novel drug there are limited data on the long-term physical, psychological, and social functioning of these patients. This study will evaluate the long-term physical and psychosocial performances and the information needs of advanced melanoma survivors who have been treated with ipilimumab.
This is a prospectively enrolling, multicentre cohort study. Objectives: To assess health-related quality of life (HRQoL), anxiety, depression, fatigue, fear of cancer recurrence, sexual health and generic health status in patients with advanced melanoma who have survived at least 2 years after ipilimumab treatment (without subsequent other systemic therapies) as compared with healthy controls, and to describe the melanoma-specific HRQoL, impact of cancer, social functioning and information needs in patients with advanced melanoma who have survived at least 2 years after ipilimumab treatment. Patients and healthy control population: Patients with advanced (stage IV or unresectable stage III) melanoma who survived at least 2 years and were treated with ipilimumab between 2011 and 2015 in 14 hospitals in the Netherlands are included. The patient population consists of 3 treatment groups based on time since ipilimumab treatment: 24 to
Clinical trial identification
Date of release: November 2016
Legal entity responsible for the study
Netherlands Cancer Institute
A.H. Boekhout: Employee of Bristol-Myers Squibb. M. Lee, KJM Janssen: Employee of and receiving stock from Bristol-Myers Squibb, during the conduct of the study. All other authors have declared no conflicts of interest.