NCT07148245 Symptoms of Immune Checkpoint Inhibitor Therapy in Cutaneous Melanoma
| NCT ID | NCT07148245 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University of California, San Francisco |
| Condition | Cutaneous Melanoma |
| Study Type | OBSERVATIONAL |
| Enrollment | 300 participants |
| Start Date | 2025-10-13 |
| Primary Completion | 2027-06-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 300 participants in total. It began in 2025-10-13 with a primary completion date of 2027-06-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
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.
Contact & Investigator
Carolyn Harris, PhD, RN
PRINCIPAL INVESTIGATOR
University of California, San Francisco
Frequently Asked Questions
Who can join the NCT07148245 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Cutaneous Melanoma. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07148245 currently recruiting?
Yes, NCT07148245 is actively recruiting participants. Contact the research team at Erin.Hubbard@ucsf.edu for enrollment information.
Where is the NCT07148245 trial being conducted?
This trial is being conducted at San Francisco, United States.
Who is sponsoring the NCT07148245 clinical trial?
NCT07148245 is sponsored by University of California, San Francisco. The principal investigator is Carolyn Harris, PhD, RN at University of California, San Francisco. The trial plans to enroll 300 participants.
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