Symptoms of Immune Checkpoint Inhibitor Therapy in Cutaneous Melanoma

Not yet recruiting

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

• Registration Number: NCT07148245
• Lead Sponsor: University of California, San Francisco

Brief Summary

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.

Detailed 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.

Study Timeline

• Study First Submitted: 2025-08-22
• Study First Submitted QC: 2025-08-22
• Study First Posted: 2025-08-29
• Status Verified: 2025-09
• Last Update Submitted: 2025-09-03
• Last Update Posted: 2025-09-10
• Study Start: 2025-09-30
• Primary Completion: 2027-06-30
• Study Completion: 2027-06-30

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 300

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Frequency of symptoms reported over time	Up 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 identified	Up 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.

Trial Locations

Locations (1)

University of California, San Francisco; 🇺🇸 San Francisco, California, United States