Understanding Symptoms of Immune Checkpoint Inhibitor Therapy for Melanoma
This study is looking at the symptoms people experience when treated with immune checkpoint inhibitors (ICIs) for advanced melanoma (stages IIB, III, or IV). ICIs have greatly improved outcomes for melanoma, but we need to better understand their side effects. This observational study will track how your symptoms change over time, identify common symptom patterns, and look for factors that might lead to worse symptoms. Researchers will review your medical charts, and you may be asked to complete questionnaires about your health and quality of life. Blood samples will also be collected during your regular clinic visits. The goal is to improve early detection of side effects, guide symptom management, and help doctors and patients make treatment decisions. This study is for adults aged 18 and older who can speak and read English, have been diagnosed with stage IIB, III, or IV cutaneous melanoma, and are scheduled to receive at least one immune checkpoint inhibitor at UCSF.
- Study design
- This is an observational study with a planned enrollment of 300 participants. It is not testing a new treatment but rather observing the effects of existing treatments.
- What's involved
- You will have your medical charts reviewed, potentially complete symptom and quality of life questionnaires, and provide blood samples during your regular clinic visits. This data collection will occur for up to 4 cycles of your treatment.
- Compensation
- Not stated in the trial record.
- Follow-up
- Your symptoms will be tracked and evaluated over time, for up to 5 months.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
Symptoms of Immune Checkpoint Inhibitor Therapy in Cutaneous Melanoma
At a glance
Conditions
Where it's being run
1 sites across 1 statesStudy leadership
- Carolyn Harris, PhD, RN · PRINCIPAL_INVESTIGATOR · University of California, San Francisco
Who to contact
Opens a ready-to-send draft in your own email app — review before sending.
Do you actually qualify for this trial?
Add a private profile and we'll compare every criterion below against your situation — and tell you which ones are met, uncertain, or excluding.
Inclusion
Exclusion
What this trial measures
- Frequency of symptoms reported over timeUp to 5 months
Evaluations of symptoms over time will be assessed via calculating the occurrence rates and means and standard deviations for the severity and distress ratings for all 53 symptoms and determine the most common, severe, and distressing symptoms over time.
- Number of distinct symptom profiles identifiedUp to 5 months
Latent class analysis will be used to identify subgroups of patients with distinct symptom occurrence profiles separately at each time point. Only symptoms that occurred in ≥20% of patients will used in the latent class analysis.
- Number of risk factors identified with worse symptom profile over time.Up to 5 months
Associations among the latent symptom occurrence profiles in demographic, clinical, environmental, and molecular characteristics along with financial toxicity, quality of life, and cancer-related distress will be evaluated using parametric and non-parametric methods to identify risk factors associated with a worse symptom profile over time.