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

Status: Recruiting
Location: See location...
Intervention Type: Other, Procedure
Study Type: Observational
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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

Locations
United States
California
University of California, San Francisco
RECRUITING
San Francisco
Contact Information
Primary
Erin Hubbard, MPH
Erin.Hubbard@ucsf.edu
(415) 502-7774
Backup
Carolyn Harris, PhD, RN
Carolyn.Harris@ucsf.edu
Time Frame
Start Date: 2025-10-13
Estimated Completion Date: 2027-06-30
Participants
Target number of participants: 300
Treatments
Adults treated with Immune Checkpoint Inhibitor Therapy
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.
Related Therapeutic Areas
Sponsors
Leads: University of California, San Francisco
Collaborators: National Cancer Institute (NCI)

This content was sourced from clinicaltrials.gov