Not Yet RecruitingPhase 2

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

20 participantsStarted 2026-08-01

Plain-language 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.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. 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.
. Patients receiving current or recent (within 6-months) treatment with immune checkpoint inhibitor(s).
. Diagnosis of Immune Checkpoint Inhibitor-Related Toxicities Mild (G1 or \<10%), Moderate (G2 or 10-30% BSA), Severe (G3 or 30+ % BSA) using CTCAE v5.0 with the following: Maculopapular rash, pruritus, bullous dermatitis, eczematous rashes, lichenoid eruption, or Psoriasis/Psoriasiform.
. Agreement to NOT use topical and systemic corticosteroids for treatment of ICI-related toxicity during the study for first 2 weeks.
. Agreement to not use systemic or biologic immunomodulating therapies during trial term unless cutaneous toxicity is not responding to Roflumilast therapy within the first 4 weeks and toxicity severity increases to high-grade (grade 3-4).

Exclusion criteria

. Subjects who have pre-existing non-cutaneous toxicities requiring systemic immunosuppression.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Percentage of patients achieving a 1+ point Change in CTCAE score at week 8

Timeframe: 8 weeks

Trial details

NCT IDNCT07639840

SponsorMassachusetts General Hospital

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2027-08-01

Contact for this trial

Yevgeniy Semenov, MD

617-723-6974 YSEMENOV@mgh.harvard.edu

View on ClinicalTrials.gov More Immune-related Dermatitis trials