Symptoms of Immune Checkpoint Inhibitor Therapy in Cutaneous Melanoma

The introduction of immune checkpoint inhibitors (ICIs) for the treatment of patients with stages IIB to IV cutaneous melanoma resulted in dramatic improvements in mortality rates for this common form of cancer. With this rapid shift in treatment, significant gaps in knowledge exist regarding the impact of ICIs on patients' symptom experiences. An in-depth characterization of inter-individual differences in patients' symptom experiences will fill this knowledge gap and assist with the early detection of ICI toxicity; guide symptom management; inform treatment decision making; and refine ICI-symptom instrument development. Furthermore, given the limited knowledge in this area, the identification of demographic, clinical, environmental, and molecular risk factors associated with a worse symptom experience is warranted. This is a longitudinal, prospective study evaluating the symptoms that immune checkpoint inhibitors may cause in patients with cutaneous melanoma.

NCT Number	NCT07148245
Lead Sponsor	University of California, San Francisco Collaborators: National Cancer Institute (NCI)
Conditions	Cutaneous Melanoma, Cutaneous Melanoma, Stage III, Cutaneous Melanoma by AJCC V7 Stage, Cutaneous Melanoma, Stage IV
Enrollment	300 participants
Start Date	2025-10-13
Primary Completion	2027-06-30 (estimated)
Study Completion	2027-06-30 (estimated)
Updated on ClinicalTrials.gov	2025-11-10