Recruiting

ICIs

Sponsor:

UCLA

Code:

NCT07148245

Conditions

Cutaneous Melanoma

Cutaneous Melanoma, Stage III

Cutaneous Melanoma by AJCC V7 Stage

Cutaneous Melanoma, Stage IV

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Blood Sample

Health Related Quality of Life Questionnaires (HRQoL)

Medical Chart Review

Study Details

Brief 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

Study ID

NCT07148245

Start date

Oct 13, 2025

Status verified date

Nov, 2025

Completion date

Jun 30, 2027

Anticipated

Primary completion date

Jun 30, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

300 participants

Anticipated

Interventions and Outcome Measures

Arms

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.

Interventions

Blood Sample

Blood samples will be collected

Health Related Quality of Life Questionnaires (HRQoL)

Participants may be given HRQoLs during the course of data collection

Medical Chart Review

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

Primary outcome measure

  • 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 ]

Central Contacts and Locations

Central contacts

Erin Hubbard, MPH

(415) 502-7774Erin.Hubbard@ucsf.edu

Carolyn Harris, PhD, RN

Carolyn.Harris@ucsf.edu

Locations

University of California, San Francisco

Recruiting

San Francisco, California, United States, 94143

Contacts

Erin Hubbard, MPH

415-502-7774Erin.Hubbard@ucsf.edu

877-827-3222cancertrials@ucsf.edu

Principal Investigator:

Carolyn Harris, PhD, RN

More Information

Sponsor

University of California, San Francisco

Last update posted

Nov 10, 2025

Last verified

Nov, 2025

Keywords

  • Toxicity

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of California, San Francisco on 2025-11-10.