Symptoms from immune checkpoint inhibitor therapy for cutaneous melanoma

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a prospective, longitudinal observational study enrolling adults with stage IIB–IV cutaneous melanoma who are starting or receiving immune checkpoint inhibitors at UCSF. Participants will have medical chart review for up to four treatment cycles, complete symptom and health-related quality-of-life questionnaires at clinic visits, and provide blood samples at scheduled visits. The study will map symptom trajectories, identify distinct symptom profiles over time, and analyze demographic, clinical, environmental, and molecular factors associated with worse symptom experiences. Results aim to improve early detection of immune-related toxicity and guide symptom management and instrument development.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* 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 Criteria:

* Participants will be excluded if they are unable to complete study requirements.

Where it's running

• University of California, San Francisco
  San Francisco, California, United States Recruiting

Study contacts

• Principal investigator: Carolyn Harris, PhD, RN — University of California, San Francisco
• Study coordinator: Erin Hubbard, MPH
• Email: Erin.Hubbard@ucsf.edu
• Phone: (415) 502-7774

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.