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NCT Number: NCT07148245

Symptoms of Immune Checkpoint Inhibitor Therapy in Cutaneous Melanoma

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.

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Key information

Conditions

Cutaneous Melanoma Cutaneous Melanoma by AJCC V7 Stage Cutaneous Melanoma, Stage III Cutaneous Melanoma, Stage IV Melanoma Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Germ Cell and Embryonal Neoplasms, Nerve Tissue Neuroectodermal Tumors Neuroendocrine Tumors Nevi and Melanomas Skin Diseases Skin Neoplasms Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

About this study

PRIMARY OBJECTIVES:

  • Evaluate for changes over time in the patients' symptom experience,
  • Identify distinct symptom profiles over time.
  • 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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Blood sample

Procedure

Blood samples will be collected

Health Related Quality of Life Questionnaires (HRQOL)

Other

Participants may be given HRQoLs during the course of data collection

Other names: Quality of Life Questionnaires, Surveys

medical chart review

Other

Participants will undergo medical charts review during the course of data collection

Other names: Chart review

Primary outcomes

  1. Frequency of symptoms reported over time

    Time frame: 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.

  2. Number of distinct symptom profiles identified

    Time frame: 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.

  3. Number of risk factors identified with worse symptom profile over time.

    Time frame: 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Carolyn Harris, PhD, RN

CONTACT

[email protected]

Erin Hubbard, MPH

CONTACT

[email protected]

(415) 502-7774

Sponsors and collaborators

Lead sponsor

University of California, San Francisco

Other

Collaborators

  • National Cancer Institute (NCI)

Registry information

Official study title

Characterization of the Symptom Experience of Patients With Cutaneous Melanoma Receiving Immune Checkpoint Inhibitor Therapy

Important dates

Study start
2025
Primary completion
2027
Study completion
2027
First posted
Aug 29, 2025
Registry last updated
Nov 10, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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