Psoriasis Clinical Trials

• Histologically confirmed advanced metastatic melanoma

• Participants of any gender who are at least 18 years of age on the day of signing informed consent

• Participants must be planned or scheduled by their treating physician to receive PD-1 therapy or PD-1 plus anti LAG3 or PD-1 plus anti CTLA-4 therapy as standard of care. Patients should either be restarting the same ICI regimen which contributed to the prior toxicity or have a clinical need to escalate to doublet (combination) ICI therapy, plan for therapy should be reviewed by the PI of this study.

• Participant (or legally acceptable representative if applicable) provides written informed consent for the trial

• Participant must have had prior treatment with ICI therapy (either PD-1 therapy or PD-1 plus anti LAG3 or PD-1 plus anti CTLA-4 therapy as standard of care) and experienced grade 2 or higher immune-related colitis, hepatitis, or skin rash leading to treatment interruption or discontinuation or requiring steroid administration (systemic or topical).

‣ Note that patients who experience more than one irAEs are eligible to participate

• Adequate organ function as defined below. Standard of care labs drawn within 42 days prior to consent may be used for the purposes of determining eligibility.

‣ Absolute Neutrophil Count (ANC) ≥ 1500/µL

⁃ Platelets ≥ 100,000/µL

⁃ Hemoglobin\* ≥ 9.0 g/dL or ≥ 5.6 mmol/L \*Criteria must be met without erythropoietin dependency and without packed red blood cell (pRBC) transfusion within the previous 2 weeks

⁃ AST/ALT 2.5x upper limit of normal