To assess the safety and efficacy of QD 0.3% topical roflumilast foam in patients with cutaneous adverse events due to checkpoint inhibitors over 16 weeks, with or without previous treatment.
Male or female subjects aged 18 years or older.
Life expectancy ≥ 36 weeks.
Eastern Cooperative Oncology Group (ECOG) performance score 0 or 1.
Participants are legally competent to sign and give informed consent.
Subjects who have pre-existing non-cutaneous toxicities requiring systemic immunosuppression.
Subjects who cannot discontinue medications and treatments prior to the Baseline visit and during the study according to Excluded Medications and Treatments (Table Excluded Medications and Treatments to be added).
Oral or colitis toxicities associated with immune checkpoint inhibitor therapy at time of study enrollment.
Subjects with any condition in the treatment area which, in the opinion of the Investigator, could confound efficacy measurements.
Single group
Roflumilast 0.3% topical foam
DrugQD treatment with roflumilast 0.3% foam
Percentage of patients achieving a 1+ point Change in CTCAE score at week 8
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