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Recruiting NCT07148245

Symptoms of Immune Checkpoint Inhibitor Therapy in Cutaneous Melanoma

— Observational Cutaneous Melanoma Cutaneous Melanoma, Stage III Cutaneous Melanoma by AJCC V7 Stage Cutaneous Melanoma, Stage IV

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Blood Sample, Health Related Quality of Life Questionnaires (HRQoL), Medical Chart Review.
Who it may be relevant to
Registry conditions: Cutaneous Melanoma, Cutaneous Melanoma, Stage III, Cutaneous Melanoma by AJCC V7 Stage, Cutaneous Melanoma, Stage IV. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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.

Interventions

  • Procedure Blood Sample
    Blood samples will be collected
  • Other Health Related Quality of Life Questionnaires (HRQoL)
    Participants may be given HRQoLs during the course of data collection
  • Other Medical Chart Review
    Participants will undergo medical charts review during the course of data collection

Primary outcome measures

  • Frequency of symptoms reported over time [Time frame: Up to 5 months]
  • Number of distinct symptom profiles identified [Time frame: Up to 5 months]
  • Number of risk factors identified with worse symptom profile over time. [Time frame: Up to 5 months]

Eligibility 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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

United States · 1 center
  • University of California, San Francisco — San Francisco

Identifiers

NCT: NCT07148245 · 25858 · NCI-2025-05718 · 4R00CA286967

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗