Clinical trial · Observational
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
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (4)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Cutaneous Melanoma | Cutaneous Melanoma | ONTOLOGY_EXACT | 0.98 |
| Cutaneous Melanoma by AJCC V7 Stage | Cutaneous Melanoma by AJCC v7 Stage | ONTOLOGY_EXACT | 0.98 |
| Cutaneous Melanoma, Stage III | Cutaneous Melanoma | CURATED_BROADER | 0.78 |
| Cutaneous Melanoma, Stage IV | Cutaneous Melanoma | CURATED_BROADER | 0.78 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Blood Sample | Procedure | — | UNRESOLVED |
| Health Related Quality of Life Questionnaires (HRQoL) | Other | — | UNRESOLVED |
| Medical Chart Review | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- Adults treated with Immune Checkpoint Inhibitor Therapy
- description
- 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.
- interventionNames
- Procedure: Blood Sample
- Other: Health Related Quality of Life Questionnaires (HRQoL)
- Other: Medical Chart Review
Primary outcomes (3)
- measure
- Frequency of symptoms reported over time
- timeFrame
- Up to 5 months
- description
- Evaluations of symptoms over time will be assessed via calculating the occurrence rates and means and standard deviations for the severity and distress ratings for all 53 symptoms and determine the most common, severe, and distressing symptoms over time.
- measure
- Number of distinct symptom profiles identified
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available