Symptoms of Immune Checkpoint Inhibitor Therapy in Cutaneous Melanoma

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorUniversity of California, San Francisco

About this trial

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

Qualifiers

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.

Disqualifiers

Participants will be excluded if they are unable to complete study requirements.

Trial design

Treatments tested in this trial

  • Blood Sample
  • Health Related Quality of Life Questionnaires (HRQoL)
  • Medical Chart Review

Treatment groups

300 Participants
are divided into 1 treatment group

Sponsors and collaborators

University of California, San Francisco

Lead sponsor

National Cancer Institute (NCI)

Collaborator