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NCT07639840
An Open-label, Single Center Study Evaluating the Safety and Efficacy of Roflumilast Foam 0.3% in Subjects With Cutaneous Adverse Events Due to Checkpoint Inhibitors
Conditions: Immune-related Dermatitis
Sex: All
Ages: 18 Years – N/A
Healthy volunteers: No
Phase: PHASE2
Enrollment: 20
Sponsor: Massachusetts General Hospital
Summary
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.
Eligibility Criteria
Inclusion Criteria:
1. Male or female subjects aged 18 years or older.
2. Life expectancy ≥ 36 weeks.
3. Eastern Cooperative Oncology Group (ECOG) performance score 0 or 1.
4. Participants are legally competent to sign and give informed consent.
5. Patients receiving current or recent (within 6-months) treatment with immune checkpoint inhibitor(s).
6. Diagnosis of Immune Checkpoint Inhibitor-Related Toxicities Mild (G1 or \
Source: ClinicalTrials.gov (NCT07639840). StuddyBuddy aggregates publicly available trial information.
