NCT04283539|Completed
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Sponsor study identifier
observational
255
1 country
3
Study Start
September 23, 2020
Actual (reported)Primary Completion
March 25, 2025
Actual (reported)Study Completion
February 28, 2026
Actual (reported)This protocol is a prospective, observational study of participants receiving immunotherapy (checkpoint inhibitors, CPI) for cancer therapy, testing the hypothesis that patients with immune related cutaneous adverse events (ircAEs) have unique immunologic endotypes associated with polarized immune responses.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
February 28, 2026
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
February 21, 2020
Actual (reported)February 25, 2020
Actual (reported)September 23, 2020
Actual (reported)March 25, 2025
Actual (reported)February 28, 2026
Actual (reported)Immune Biomarkers
cytokines and chemokines
30 days
Presence of skin and circulating lipid biomarkers which occur during and after ircAEs
30 days
Mechanisms associated with corticosteroid unresponsiveness in patients with ircAE
12 months
Participants on check point inhibitors with immune related cutaneous adverse event
Participants who do not have a cutaneous adverse event
Treatment with systemic corticosteroids or biologic therapies (for corticosteroid refractory patients or these in which corticosteroids are not the treatment of choice)
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Adult male or female with diagnosis of solid tumor
National Jewish Health
Denver, Colorado, 80206, United States
The Melanoma and Skin Cancer Institute
Denver, Colorado, 80206, United States
Memorial Sloan Kettering Cancer Center
New York, New York, 10065, United States
Wang EA, Goleva E, Ketosugbo K, Kern JA, Kraehenbuehl L, Lacouture ME, Leung DYM. Effect of immune checkpoint inhibitors on asthma. Ann Allergy Asthma Immunol. 2022 Aug;129(2):257-258. doi: 10.1016/j.anai.2022.05.019. Epub 2022 May 24. No abstract available.
Luo J, Beattie JA, Fuentes P, Rizvi H, Egger JV, Kern JA, Leung DYM, Lacouture ME, Kris MG, Gambarin M, Santomasso BD, Faleck DM, Hellmann MD. Beyond Steroids: Immunosuppressants in Steroid-Refractory or Resistant Immune-Related Adverse Events. J Thorac Oncol. 2021 Oct;16(10):1759-1764. doi: 10.1016/j.jtho.2021.06.024. Epub 2021 Jul 12.
Blood Skin biopsies Skin tape stripping Urine
Donald Leung, MD, PhD
National Jewish Health
255 participants (actual enrollment reported by the registry).
First Submitted
February 21, 2020
First Posted
February 25, 2020
Study Start
September 23, 2020
Actual (reported)Induction of Sensecence Using Dexamethasone to Re-sensitize NSCLC to Anti-PD1 Therapy
Contact the study team to confirm eligibility.
Goleva E, Lyubchenko T, Kraehenbuehl L, Lacouture ME, Leung DYM, Kern JA. Our current understanding of checkpoint inhibitor therapy in cancer immunotherapy. Ann Allergy Asthma Immunol. 2021 Jun;126(6):630-638. doi: 10.1016/j.anai.2021.03.003. Epub 2021 Mar 11.
Geisler AN, Phillips GS, Barrios DM, Wu J, Leung DYM, Moy AP, Kern JA, Lacouture ME. Immune checkpoint inhibitor-related dermatologic adverse events. J Am Acad Dermatol. 2020 Nov;83(5):1255-1268. doi: 10.1016/j.jaad.2020.03.132. Epub 2020 May 23.
Wang E, Kraehenbuehl L, Ketosugbo K, Kern JA, Lacouture ME, Leung DYM. Immune-related cutaneous adverse events due to checkpoint inhibitors. Ann Allergy Asthma Immunol. 2021 Jun;126(6):613-622. doi: 10.1016/j.anai.2021.02.009. Epub 2021 Feb 17.
Goleva E, Lacouture ME, Moy AP, Kern JA, Leung DYM. Phenotype/Immunologic Profiling in ircAEs-Response. Clin Cancer Res. 2024 Dec 16;30(24):5694. doi: 10.1158/1078-0432.CCR-24-2949. No abstract available.
Lacouture ME, Goleva E, Shah N, Rotemberg V, Kraehenbuehl L, Ketosugbo KF, Merghoub T, Maier T, Bang A, Gu S, Salvador T, Moy AP, Lyubchenko T, Xiao O, Hall CF, Berdyshev E, Crooks J, Weight R, Kern JA, Leung DYM. Immunologic Profiling of Immune-Related Cutaneous Adverse Events with Checkpoint Inhibitors Reveals Polarized Actionable Pathways. Clin Cancer Res. 2024 Jul 1;30(13):2822-2834. doi: 10.1158/1078-0432.CCR-23-3431.
Primary Completion
March 25, 2025
Actual (reported)Study Completion
February 28, 2026
Actual (reported)Last Updated
June 16, 2026
Record last verified: 2026-06
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Source: ClinicalTrials.gov.
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