About this trial
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 criteria
Qualifiers
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.
Disqualifiers
Participants will be excluded if they are unable to complete study requirements.
Trial design
Treatments tested in this trial
- Blood Sample
- Health Related Quality of Life Questionnaires (HRQoL)
- Medical Chart Review
Treatment groups
Sponsors and collaborators
University of California, San Francisco
Lead sponsor
National Cancer Institute (NCI)
Collaborator