NCT04283539

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
255

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Sep 2020

Longer than P75 for all trials

Geographic Reach
1 country

3 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 21, 2020

Completed
4 days until next milestone

First Posted

Study publicly available on registry

February 25, 2020

Completed
7 months until next milestone

Study Start

First participant enrolled

September 23, 2020

Completed
4.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 25, 2025

Completed
11 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 28, 2026

Completed
Last Updated

June 16, 2026

Status Verified

June 1, 2026

Enrollment Period

4.5 years

First QC Date

February 21, 2020

Last Update Submit

June 12, 2026

Conditions

CancerSkin DiseaseImmunotherapyPatients 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 inhibitorimmuno-oncologycutaneous adverse eventsimmunotherapy

Outcome Measures

Primary Outcomes (1)

  • Immune Biomarkers

    cytokines and chemokines

    30 days

Secondary Outcomes (2)

  • 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

Study Arms (2)

CPI with ircAE

Participants on check point inhibitors with immune related cutaneous adverse event

Drug: systemic corticosteroid or biologic

no ircAE

Participants who do not have a cutaneous adverse event

Interventions

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)

CPI with ircAE

Eligibility Criteria

Age18 Years - 99 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Adult male or female with diagnosis of solid tumor

You may qualify if:

  • 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)
  • No ircAE (cohort 2 only)
  • An indication for system corticosteroids or biologic therapies as determined by the treating physician (for cohort 1 only)
  • \. Life expectancy ≥ 12 weeks

You may not qualify if:

  • 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
  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

National Jewish Health

Denver, Colorado, 80206, United States

Location

The Melanoma and Skin Cancer Institute

Denver, Colorado, 80206, United States

Location

Memorial Sloan Kettering Cancer Center

New York, New York, 10065, United States

Location

Related Publications (7)

  • 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.

    PMID: 35623586BACKGROUND

  • 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.

    PMID: 34265432BACKGROUND

  • 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.

    PMID: 33716146BACKGROUND

  • 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.

    PMID: 32454097BACKGROUND

  • 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.

    PMID: 33609771RESULT

  • 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.

    PMID: 39676538RESULT

  • 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.

    PMID: 38652814RESULT

Biospecimen

Retention: SAMPLES WITH DNA

Blood Skin biopsies Skin tape stripping Urine

MeSH Terms

Conditions

NeoplasmsSkin Diseases

Interventions

Biological Products

Condition Hierarchy (Ancestors)

Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Complex Mixtures

Study Officials

  • Donald Leung, MD, PhD

    National Jewish Health

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor of Medicine

Study Record Dates

First Submitted

February 21, 2020

First Posted

February 25, 2020

Study Start

September 23, 2020

Primary Completion

March 25, 2025

Study Completion

February 28, 2026

Last Updated

June 16, 2026

Record last verified: 2026-06

Locations

US(3)