Symptoms of Immune Checkpoint Inhibitor Therapy in Cutaneous Melanoma
Characterization of the Symptom Experience of Patients With Cutaneous Melanoma Receiving Immune Checkpoint Inhibitor Therapy
University of California, San Francisco
300 participants
Oct 13, 2025
OBSERVATIONAL
Conditions
Summary
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.
Eligibility
Inclusion Criteria6
- Adults ≥18 years of age
- Able to speak and read English
- Diagnosed with stage IIB, III, or IV cutaneous melanoma
- Participants who are scheduled to receive \>=1 immune checkpoint inhibitor at University of California San Francisco medical center locations. Participants on targeted therapies (e.g., BRAF or mitogen-activated extracellular signal-regulated kinase (MEK) inhibitors) will be eligible.
- Provide written informed consent to participate in this study.
- Participants with stage IIB or higher cutaneous melanoma
Exclusion Criteria1
- Participants will be excluded if they are unable to complete study requirements.
Interventions
Blood samples will be collected
Participants may be given HRQoLs during the course of data collection
Participants will undergo medical charts review during the course of data collection
Locations(1)
View Full Details on ClinicalTrials.gov
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NCT07148245