Identification of Pathways to Mitigate Immune-Related Adverse Events With Cancer Immunotherapy

NCT04283539 | Unknown

• 1 other identifier: ircAE HS-3411
• Study Type: observational
• Target: 238
• Locations: 1 country
• Sites: 3

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.

Conditions

Cancer

Keywords

checkpoint inhibitor; immuno-oncology; cutaneous adverse events

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 biologic DRUG

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

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-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
• Receiving, or prior to starting on, a checkpoint inhibitor
• Grade ≥ 2 ircAE (CTCAE v 5.0) (for cohort 1 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 pervious 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

Sponsors & Collaborators

• National Jewish Health: lead
• Memorial Sloan Kettering Cancer Center: collaborator

Study Sites (3)

National Jewish Health

Denver, Colorado, 80206, United States

RECRUITING

The Melanoma and Skin Cancer Institute

Denver, Colorado, 80206, United States

RECRUITING

Memorial Sloan Kettering Cancer Center

New York, New York, 10065, United States

RECRUITING

MeSH Terms

Conditions

Neoplasms

Interventions

Biological Products

Intervention Hierarchy (Ancestors)

Complex Mixtures

Central Study Contacts

Joanne Streib

CONTACT

303-398-1731; streibj@njhealth.org

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: June 1, 2020
• Primary Completion: June 1, 2024
• Study Completion: February 1, 2025
• Last Updated: November 13, 2023

Record last verified: 2023-11

Locations

US (3)