CancerNCT04283539
Identification of Pathways to Mitigate Immune-Related Adverse Events With Cancer Immunotherapy
An observational study of Cancer and Skin Disease, run by National Jewish Health at 3 sites in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Cancer, Skin Disease, Immunotherapy
- What is being tested?
- systemic corticosteroid or biologic
- How many people
- 255 participants
- Where
- 3 sitesUnited States
- Study dates
- 23 Sep 2020to 28 Feb 2026
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adult male or female with diagnosis of solid tumor
Who may be able to join
- Provision of signed and dated informed consent form
- Stated willingness to comply with all study procedures and availability for the duration of the study
- Male or female, >18 yo
- Diagnosis of solid tumor including, but not limited to, genitourinary/gynecologic, lung, gastrointestinal and melanoma
- Received or receiving a Check Point Inhibitor, or prior to starting on a checkpoint inhibitor
- Grade ≥ 1 ircAE (CTCAE v 5.0) (for cohort 1 only)
Show all 9Show fewer
- No ircAE (cohort 2 only)
- An indication for system corticosteroids or biologic therapies as determined by the treating physician (for cohort 1 only)
- 8. Life expectancy ≥ 12 weeks
Who cannot join
- 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.
- Enrollment in any investigational drug trial with a drug that has not been approved
- Taking other checkpoint inhibitors beyond anti-PD-(L)-1 or anti-CTLA-4 not yet indicated/approved for use
- Pregnancy
- Known blood borne infectious disease
- Current or previous diagnosis of a leukemia or lymphoma
Show all 9Show fewer
- Unable to give consent for study participation
- Life expectancy < 12 weeks
- Any other condition or diagnosis in the opinion of the investigator that would interfere with the study results
Trial locations and contacts
3 sites in 1 country.
United States3 sites
National Jewish Health
Denver, Colorado, 80206
The Melanoma and Skin Cancer Institute
Denver, Colorado, 80206
Memorial Sloan Kettering Cancer Center
New York, New York, 10065
About this study
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.
Read the detailed description
This 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.
In addition, this 2-arm pilot randomized controlled trial evaluating the impact of a patient navigation/side effects management intervention versus usual and customary care, on immune checkpoint inhibitor (ICI) continuation at 6 months (primary outcome) as well as occurrence, severity, and management of immune-related AEs (irAEs); quality of life; and progression-free survival (PFS) (secondary outcomes) in a cohort of minoritized and/or low socioeconomic status (SES) cancer patients receiving ICIs.
- Conditions
- Cancer, Skin Disease, Immunotherapy, Patients With Solid Tumors Receiving Immunotherapy With an ICI Will be Randomized to Participate in an SDoH and Side Effects Navigation Program vs. Control
- Being tested
- systemic corticosteroid or biologic
- Keywords
- checkpoint inhibitor, immuno-oncology, cutaneous adverse events, immunotherapy
- Medical subject headings
- Neoplasms, Skin Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
systemic corticosteroid or biologicDrug
Treatment with systemic corticosteroids or biologic therapies (for corticosteroid refractory patients or these in which corticosteroids are not the treatment of choice)
| Study group | Role | What they receive |
|---|---|---|
| CPI with ircAE | Participants on check point inhibitors with immune related cutaneous adverse event Receives: Drug: systemic corticosteroid or biologic | |
| no ircAE | Participants who do not have a cutaneous adverse event |
What is being measured
The primary outcome is the main question the study is designed to answer.
Immune Biomarkers
cytokines and chemokines
Measured: 30 days
Secondary outcomes (2)
Presence of skin and circulating lipid biomarkers which occur during and after ircAEs
Proportion of long-chain and short-chain ceramides Amounts and relative proportion of lysophosphatidylcholine molecular species. sphingosine-1-phosphate, platelet activating factor, leukotriene E4, prostaglandin F2α, endocannabinoids anandamide and 2- arachidonoylglycerol.
Peripheral blood mononuclear cell RNA for expression of GRalpha, GRbeta, Vitamin D 24- Hydroxylase FK506 binding protein 5, mitogen induced kinase phosphatase 1, interleukin, tumor necrosis factor alphal
Measured: 30 days
Mechanisms associated with corticosteroid unresponsiveness in patients with ircAE
Proportion of long-chain and short-chain ceramides Amounts and relative proportion of lysophosphatidylcholine molecular species. sphingosine-1-phosphate, platelet activating factor, leukotriene E4, prostaglandin F2α, endocannabinoids anandamide and 2- arachidonoylglycerol.
Peripheral blood mononuclear cell RNA for expression of GRalpha, GRbeta, Vitamin D 24- Hydroxylase FK506 binding protein 5, mitogen induced kinase phosphatase 1, interleukin, tumor necrosis factor alphal
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Feb 2020
- Study start23 Sep 2020
- Primary completion25 Mar 2025
- Study completion28 Feb 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 255 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Jewish Health
- Sponsor type
- University, hospital or other
- Collaborators
- Memorial Sloan Kettering Cancer Center
- Responsible party
- Principal investigator, Jeffrey Kern, National Jewish Health
- Investigators
- Donald Leung, MD, PhD, Principal investigator, National Jewish Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04283539
- Sponsor's protocol ID
- ircAE HS-3411
- Status last verified
- Jun 2026
- First submitted
- 21 Feb 2020
- Last updated
- 16 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 35623586Luo 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.
PubMed 34265432Goleva 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.
PubMed 33716146Geisler 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.
PubMed 32454097Wang 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.
PubMed 33609771Goleva 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.
PubMed 39676538Lacouture 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.
PubMed 38652814
Study at a glance
From the registry record, last updated by the sponsor on 16 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Identification of Pathways to Mitigate Immune-Related Adverse Events With Cancer Immunotherapy
- ClinicalTrials.gov ID
- NCT04283539
- Acronym / sponsor ID
- ircAE HS-3411
- Conditions
- Cancer, Skin Disease, Immunotherapy, Patients With Solid Tumors Receiving Immunotherapy With an ICI Will be Randomized to Participate in an SDoH and Side Effects Navigation Program vs. Control
- Keywords
- checkpoint inhibitor, immuno-oncology, cutaneous adverse events, immunotherapy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 255 participants (actual)
- Lead sponsor
- National Jewish HealthUniversity, hospital or other
- Collaborators
- Memorial Sloan Kettering Cancer Center
- Study start
- 23 Sep 2020 (actual)
- Primary completion
- 25 Mar 2025 (actual)
- Study completion
- 28 Feb 2026 (actual)
- First posted
- 25 Feb 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
This 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.
In addition, this 2-arm pilot randomized controlled trial evaluating the impact of a patient navigation/side effects management intervention versus usual and customary care, on immune checkpoint inhibitor (ICI) continuation at 6 months (primary outcome) as well as occurrence, severity, and management of immune-related AEs (irAEs); quality of life; and progression-free survival (PFS) (secondary outcomes) in a cohort of minoritized and/or low socioeconomic status (SES) cancer patients receiving ICIs.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CPI with ircAE | – | Drug: systemic corticosteroid or biologicParticipants on check point inhibitors with immune related cutaneous adverse event |
| no ircAE | – | –Participants who do not have a cutaneous adverse event |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult male or female with diagnosis of solid tumor
Key inclusion criteria (9 listed)
- Provision of signed and dated informed consent form
- Stated willingness to comply with all study procedures and availability for the duration of the study
- Male or female, >18 yo
- Diagnosis of solid tumor including, but not limited to, genitourinary/gynecologic, lung, gastrointestinal and melanoma
- Received or receiving a Check Point Inhibitor, or prior to starting on a checkpoint inhibitor
Key exclusion criteria (9 listed)
- 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.
- Enrollment in any investigational drug trial with a drug that has not been approved
- Taking other checkpoint inhibitors beyond anti-PD-(L)-1 or anti-CTLA-4 not yet indicated/approved for use
- Pregnancy
- Known blood borne infectious disease
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| systemic corticosteroid or biologicTreatment with systemic corticosteroids or biologic therapies (for corticosteroid refractory patients or these in which corticosteroids are not the treatment of choice) | Drug | CPI with ircAE |
Primary outcome
Immune Biomarkers
Time frame: 30 days
cytokines and chemokines
2 secondary outcomes
Presence of skin and circulating lipid biomarkers which occur during and after ircAEs
Time frame: 30 days
Mechanisms associated with corticosteroid unresponsiveness in patients with ircAE
Time frame: 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jun 2026.
- Background: PubMed 35623586Wang 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.
- Background: PubMed 34265432Luo 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.
- Background: PubMed 33716146Goleva 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.
- Background: PubMed 32454097Geisler 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.
- Results publication: PubMed 33609771Wang 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.
- Results publication: PubMed 39676538Goleva 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.
- Results publication: PubMed 38652814Lacouture 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Donald Leung, MD, PhD principal investigator
National Jewish Health
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cancer and Skin Disease, run by National Jewish Health at 3 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Immune Biomarkers (time frame: 30 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04283539, which also lists 7 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jun 2026.