Symptoms of Immune Checkpoint Inhibitor Therapy in Cutaneous Melanoma

University of California San Francisco (UCSF)

Status: Enrolling

Conditions: Cutaneous Melanoma, Stage III; Cutaneous Melanoma by AJCC V7 Stage; Cutaneous Melanoma, Stage IV; Cutaneous Melanoma

Treatments: Other: Medical Chart Review; Procedure: Blood Sample; Other: Health Related Quality of Life Questionnaires (HRQoL)

Study type: Observational

Funder types: Other; NIH

Identifiers

NCT07148245

NCI-2025-05718 (Registry Identifier)

4R00CA286967 (U.S. NIH Grant/Contract)

25858

Details and patient eligibility

About

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.

Full description

PRIMARY OBJECTIVES:

1. Evaluate for changes over time in the patients' symptom experience,
2. Identify distinct symptom profiles over time.
3. Evaluate for demographic, clinical, environmental, and molecular risk factors associated with a worse profile.

OUTLINE:

Participants receiving ICI outside the scope of this study as part of usual care will have a chart review from the first cycle of non-investigational treatment for up to 4 cycles. Participants may complete symptom and health-related quality of life questionnaires during the course of the study, and blood samples will be obtained at regular clinic visits.

Enrollment: 300 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

300 participants in 1 patient group

Adults treated with Immune Checkpoint Inhibitor Therapy

Description:

Adult participants diagnosed with stage IIB to IV cutaneous melanoma who will begin immune checkpoint therapy at University of California, San Francisco medical center locations.

Treatment:

Other: Health Related Quality of Life Questionnaires (HRQoL)

Procedure: Blood Sample

Other: Medical Chart Review