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Symptoms of Immune Checkpoint Inhibitor Therapy in Cutaneous Melanoma

NCT07148245 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 300

Last updated 2025-11-10

No results posted yet for this study

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.

Conditions

  • Cutaneous Melanoma
  • Cutaneous Melanoma, Stage III
  • Cutaneous Melanoma by AJCC V7 Stage
  • Cutaneous Melanoma, Stage IV

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

Sponsors & Collaborators

Principal Investigators

  • Carolyn Harris, PhD, RN · University of California, San Francisco

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-10-13
Primary Completion
2027-06-30
Completion
2027-06-30

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07148245 on ClinicalTrials.gov