Cutaneous MelanomaNCT07148245
Symptoms of Immune Checkpoint Inhibitor Therapy in Cutaneous Melanoma
An observational study of Cutaneous Melanoma and Cutaneous Melanoma, Stage III, run by University of California, San Francisco at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cutaneous Melanoma, Cutaneous Melanoma, Stage III, Cutaneous Melanoma by AJCC V7 Stage
- What is being tested?
- Blood Sample, Health Related Quality of Life Questionnaires (HRQoL) and Medical Chart Review
- Type of treatment
- Injection or infusion, Surgery or procedure
- How many people
- 300 participants
- Where
- 1 siteUnited States
- Study dates
- 13 Oct 2025to 30 Jun 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adult participants with stage IIB, III, or IV cutaneous melanoma who will receive ≥ 1 immune checkpoint inhibitor therapy as part of treatment for cutaneous melanoma.
Who may be able to join
- 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
Who cannot join
- Participants will be excluded if they are unable to complete study requirements.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Carolyn Harris, PhD, RN contact
United States1 site, 1 recruiting
- Recruiting
University of California, San Francisco
San Francisco, California, 94143
Erin Hubbard, MPH, 415-502-7774, Erin.Hubbard@ucsf.edu
877-827-3222, cancertrials@ucsf.edu
About this study
Official title: Characterization of the Symptom Experience of Patients With Cutaneous Melanoma Receiving Immune Checkpoint Inhibitor Therapy
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.
Read the detailed description
PRIMARY OBJECTIVES:
- Evaluate for changes over time in the patients' symptom experience,
- Identify distinct symptom profiles over time.
- Evaluate for demographic, clinical, environmental, and molecular risk factors associated with a worse profile.
OUTLINE:
Participants receiving ICI outside the scope of this study as part of usual care will have a chart review from the first cycle of non-investigational treatment for up to 4 cycles. Participants may complete symptom and health-related quality of life questionnaires during the course of the study, and blood samples will be obtained at regular clinic visits.
- Conditions
- Cutaneous Melanoma, Cutaneous Melanoma, Stage III, Cutaneous Melanoma by AJCC V7 Stage, Cutaneous Melanoma, Stage IV
- Being tested
- Blood Sample, Health Related Quality of Life Questionnaires (HRQoL), Medical Chart Review
- Keywords
- Toxicity
- Medical subject headings
- Melanoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blood SampleProcedure or surgery
Blood samples will be collected
Health Related Quality of Life Questionnaires (HRQoL)Other
Also called Quality of Life Questionnaires, Surveys
Participants may be given HRQoLs during the course of data collection
Medical Chart ReviewOther
Also called Chart review
Participants will undergo medical charts review during the course of data collection
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Procedure: Blood Sample; Other: Health Related Quality of Life Questionnaires (HRQoL); Other: Medical Chart Review |
What is being measured
The primary outcome is the main question the study is designed to answer.
Frequency of symptoms reported over time
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.
Measured: Up to 5 months
Number of distinct symptom profiles identified
Latent class analysis will be used to identify subgroups of patients with distinct symptom occurrence profiles separately at each time point. Only symptoms that occurred in ≥20% of patients will used in the latent class analysis.
Measured: Up to 5 months
Number of risk factors identified with worse symptom profile over time.
Associations among the latent symptom occurrence profiles in demographic, clinical, environmental, and molecular characteristics along with financial toxicity, quality of life, and cancer-related distress will be evaluated using parametric and non-parametric methods to identify risk factors associated with a worse symptom profile over time.
Measured: Up to 5 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Aug 2025
- Study start13 Oct 2025
- Primary completion30 Jun 2027 (estimated)
- Study completion30 Jun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cutaneous MelanomaStudies of the same condition, open and under way.
- More trials run by University of California, San FranciscoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of California, San Francisco
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Carolyn Harris, PhD, RN, Principal investigator, University of California, San Francisco
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07148245
- Sponsor's protocol ID
- 25858
- Other IDs
- NCI-2025-05718, 4R00CA286967
- Status last verified
- Nov 2025
- First submitted
- 22 Aug 2025
- Last updated
- 10 Nov 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified datasets may be shared with study collaborators during the course of the study.
Study at a glance
From the registry record, last updated by the sponsor on 10 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Characterization of the Symptom Experience of Patients With Cutaneous Melanoma Receiving Immune Checkpoint Inhibitor Therapy
- ClinicalTrials.gov ID
- NCT07148245
- Acronym / sponsor ID
- 25858
- Conditions
- Cutaneous Melanoma, Cutaneous Melanoma, Stage III, Cutaneous Melanoma by AJCC V7 Stage, Cutaneous Melanoma, Stage IV
- Keywords
- Toxicity
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- University of California, San FranciscoUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- 13 Oct 2025 (actual)
- Primary completion
- 30 Jun 2027 (estimated)
- Study completion
- 30 Jun 2027 (estimated)
- First posted
- 29 Aug 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
PRIMARY OBJECTIVES:
- Evaluate for changes over time in the patients' symptom experience,
- Identify distinct symptom profiles over time.
- Evaluate for demographic, clinical, environmental, and molecular risk factors associated with a worse profile.
OUTLINE:
Participants receiving ICI outside the scope of this study as part of usual care will have a chart review from the first cycle of non-investigational treatment for up to 4 cycles. Participants may complete symptom and health-related quality of life questionnaires during the course of the study, and blood samples will be obtained at regular clinic visits.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Adults treated with Immune Checkpoint Inhibitor Therapy | – | Procedure: Blood Sample, Other: Health Related Quality of Life Questionnaires (HRQoL), Other: Medical Chart ReviewAdult participants diagnosed with stage IIB to IV cutaneous melanoma who will begin immune checkpoint therapy at University of California, San Francisco medical center locations. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult participants with stage IIB, III, or IV cutaneous melanoma who will receive ≥ 1 immune checkpoint inhibitor therapy as part of treatment for cutaneous melanoma.
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (1 listed)
- Participants will be excluded if they are unable to complete study requirements.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Blood SampleBlood samples will be collected | Procedure or surgery | Adults treated with Immune Checkpoint Inhibitor Therapy |
| Health Related Quality of Life Questionnaires (HRQoL)Also: Quality of Life Questionnaires, SurveysParticipants may be given HRQoLs during the course of data collection | Other | Adults treated with Immune Checkpoint Inhibitor Therapy |
| Medical Chart ReviewAlso: Chart reviewParticipants will undergo medical charts review during the course of data collection | Other | Adults treated with Immune Checkpoint Inhibitor Therapy |
Primary outcome
Frequency of symptoms reported over time
Time frame: Up to 5 months
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.
Number of distinct symptom profiles identified
Time frame: Up to 5 months
Latent class analysis will be used to identify subgroups of patients with distinct symptom occurrence profiles separately at each time point. Only symptoms that occurred in ≥20% of patients will used in the latent class analysis.
Number of risk factors identified with worse symptom profile over time.
Time frame: Up to 5 months
Associations among the latent symptom occurrence profiles in demographic, clinical, environmental, and molecular characteristics along with financial toxicity, quality of life, and cancer-related distress will be evaluated using parametric and non-parametric methods to identify risk factors associated with a worse symptom profile over time.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Nov 2025.
- Individual participant dataSharing planned: Yes. De-identified datasets may be shared with study collaborators during the course of the study.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Carolyn Harris, PhD, RN contact
Carolyn Harris, PhD, RN principal investigator
University of California, San Francisco
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cutaneous Melanoma and Cutaneous Melanoma, Stage III, run by University of California, San Francisco at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 10 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Erin Hubbard, MPH ((415) 502-7774, Erin.Hubbard@ucsf.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Frequency of symptoms reported over time (time frame: Up to 5 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Nov 2025.