Symptoms from immune checkpoint inhibitor therapy for cutaneous melanoma
Characterization of the Symptom Experience of Patients With Cutaneous Melanoma Receiving Immune Checkpoint Inhibitor Therapy
University of California, San Francisco · NCT07148245
We will follow adults with stage IIB–IV cutaneous melanoma who are receiving immune checkpoint inhibitors to see how their symptoms change over time and which factors are linked to worse symptom patterns.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 300 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University of California, San Francisco (other) |
| Locations | 1 site (San Francisco, California) |
| Trial ID | NCT07148245 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Adults aged 18 or older with stage IIB, III, or IV cutaneous melanoma who are scheduled to receive one or more immune checkpoint inhibitors at University of California San Francisco medical center locations and can read English and give informed consent.
Not a fit: People who are not receiving immune checkpoint inhibitors, who have melanoma below stage IIB, who cannot complete study requirements, or who cannot consent or read English are unlikely to benefit from this study.
Why it matters
Potential benefit: If successful, this work could help clinicians detect immune checkpoint inhibitor toxicity earlier and tailor symptom management for people with cutaneous melanoma.
How similar studies have performed: While immune checkpoint inhibitor toxicities are well described clinically, comprehensive longitudinal symptom profiling in cutaneous melanoma is limited, making this a relatively novel and needed approach.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
San Francisco, California
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Cutaneous Melanoma, Cutaneous Melanoma, Stage III, Cutaneous Melanoma by AJCC V7 Stage, Cutaneous Melanoma, Stage IV, Toxicity