Clinical trial · Observational
Identification of Pathways to Mitigate Immune-Related Adverse Events With Cancer Immunotherapy
NCT04283539CI-TRIAL-00114939completedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (4)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Cancer | Malignant Neoplasm | ALIAS | 0.90 |
| Immunotherapy | — | UNRESOLVED | — |
| Patients With Solid Tumors Receiving Immunotherapy With an ICI Will be Randomized to Participate in an SDoH and Side Effects Navigation Program vs. Control | — | UNRESOLVED | — |
| Skin Disease | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| systemic corticosteroid or biologic | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- label
- CPI with ircAE
- description
- Participants on check point inhibitors with immune related cutaneous adverse event
- interventionNames
- Drug: systemic corticosteroid or biologic
- label
- no ircAE
- description
- Participants who do not have a cutaneous adverse event
Primary outcomes (1)
- measure
- Immune Biomarkers
- timeFrame
- 30 days
- description
- cytokines and chemokines
Secondary outcomes (2)
- measure
- Presence of skin and circulating lipid biomarkers which occur during and after ircAEs
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 99 Years
Show eligibility criteria text
Inclusion Criteria: 1. Provision of signed and dated informed consent form 2. Stated willingness to comply with all study procedures and availability for the duration of the study 3. Male or female, \>18 yo 4. Diagnosis of solid tumor including, but not limited to, genitourinary/gynecologic, lung, gastrointestinal and melanoma 5. Received or receiving a Check Point Inhibitor, or prior to starting on a checkpoint inhibitor 6. Grade ≥ 1 ircAE (CTCAE v 5.0) (for cohort 1 only) 7. No ircAE (cohort 2 only) 8. An indication for system corticosteroids or biologic therapies as determined by the treating physician (for cohort 1 only) 8\. Life expectancy ≥ 12 weeks Exclusion Criteria: 1. Daily use of systemic steroid treatment in the past 4 weeks (prednisone \>10mg a day or equivalent) except for indications other than the cutaneous adverse event, and/or as an anti-emetic pre- or post-chemotherapy infusions. 2. Enrollment in any investigational drug trial with a drug that has not been approved 3. Taking other checkpoint inhibitors beyond anti-PD-(L)-1 or anti-CTLA-4 not yet indicated/approved for use 4. Pregnancy 5. Known blood borne infectious disease 6. Current or previous diagnosis of a leukemia or lymphoma 7. Unable to give consent for study participation 8. Life expectancy \< 12 weeks 9. Any other condition or diagnosis in the opinion of the investigator that would interfere with the study results
References
Publications (7)
- BACKGROUNDWang 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. PMID 35623586
- BACKGROUNDLuo 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. PMID 34265432
- BACKGROUNDGoleva 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. PMID 33716146
- BACKGROUNDGeisler 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. PMID 32454097
- RESULTWang 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. PMID 33609771
- RESULTGoleva 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. PMID 39676538
- RESULTLacouture 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.