Symptoms of Immune Checkpoint Inhibitor Therapy in Cutaneous Melanoma

Part of paid clinical trials in San Francisco, California.

Sponsor
University of California, San Francisco
Study ID
NCT07148245
Status
Recruiting
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Conditions

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

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • 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
  • Medical Chart Review — OTHER
    Participants will undergo medical charts review during the course of data collection

Study Details

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.

Key Dates

Start date
Oct 13, 2025
Status verified
Nov 2025
Primary completion
Jun 30, 2027
Completion
Jun 30, 2027

Study Design

Enrollment
300 participants (estimated)

Arms

  • Arm: 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.

Primary Outcome Measure

Frequency of symptoms reported over time [ Time Frame: Up to 5 months ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
University of California, San FranciscoSan FranciscoCalifornia94143
Erin Hubbard, MPH
[email protected]
415-502-7774
[email protected]
877-827-3222
Carolyn Harris, PhD, RN (PRINCIPAL_INVESTIGATOR)

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