NCT07148245Recruiting
Symptoms of Immune Checkpoint Inhibitor Therapy in Cutaneous Melanoma
Characterization of the Symptom Experience of Patients With Cutaneous Melanoma Receiving Immune Checkpoint Inhibitor Therapy
Source: ClinicalTrials.gov · Last updated 10 Nov 2025
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Observational
- Enrollment
- 300 (estimated)
- First submitted
- 22 Aug 2025
- Start date
- Oct 2025
- Primary completion date
- Jun 2027
- Lead sponsor
- University of California, San Francisco
- Diseases
- Melanoma
- NCT number
- NCT07148245
What you commit to
- Study type: Observational
- Planned participants: 300
- From Oct 2025 to the primary completion date, Jun 2027
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other
- Participants will be excluded if they are unable to complete study requirements.
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| University of California San Francisco Coordinator of this site? Confirm its status | San Francisco | United States | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.