Symptoms of Immune Checkpoint Inhibitor Therapy in Cutaneous Melanoma

What this study involves

The registry says this study is recruiting. Individual locations may have different availability.

Study type

Observational

Phase

Not applicable / not listed

Age range

18 years - Not specified

Sex eligible

All sexes

Healthy volunteers

Not accepted

Participants

300 Estimated

These are starting points, not an eligibility decision. The research team must review the full requirements.

About the research

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.

Who may be able to participate?

The list below is the sponsor’s full registry wording. It can include conditions, prior treatment, test results and other requirements. A match in search does not mean you qualify.

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.

Study population

Adult participants with stage IIB, III, or IV cutaneous melanoma who will receive ≥ 1 immune checkpoint inhibitor therapy as part of treatment for cutaneous melanoma.

Treatment, groups and participation

The registry may describe treatments and study duration without a complete visit calendar. Ask the study team for the exact schedule, procedures, risks, costs and alternatives. Keep your usual care plan unless your treating clinician tells you otherwise.

Assignment

Not reported

Masking

Not reported

What researchers are measuring

Outcome measures describe what is being studied. They are not proof that a treatment works.

Primary measures

Research locations (1)

The overall study status and a local site’s status can differ. Confirm that location’s availability before traveling.

1 locations

Study team and timeline

Lead sponsor

University of California, San Francisco

Study start

Oct 13, 2025 Actual

Primary completion

Jun 30, 2027 Estimated

Study completion

Jun 30, 2027 Estimated

First posted

Aug 29, 2025 Actual

Last updated

Nov 10, 2026 Actual

Official study contacts