Identification of Pathways to Mitigate Immune-Related Adverse Events With Cancer Immunotherapy
NCT ID: NCT04283539
Last Updated: 2023-11-13
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
238 participants
OBSERVATIONAL
2020-06-01
2025-02-28
Brief Summary
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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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CPI with ircAE
Participants on check point inhibitors with immune related cutaneous adverse event
systemic corticosteroid or biologic
Treatment with systemic corticosteroids or biologic therapies (for corticosteroid refractory patients or these in which corticosteroids are not the treatment of choice)
no ircAE
Participants who do not have a cutaneous adverse event
No interventions assigned to this group
Interventions
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systemic corticosteroid or biologic
Treatment with systemic corticosteroids or biologic therapies (for corticosteroid refractory patients or these in which corticosteroids are not the treatment of choice)
Eligibility Criteria
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Inclusion Criteria
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. Receiving, or prior to starting on, a checkpoint inhibitor
6. Grade ≥ 2 ircAE (CTCAE v 5.0) (for cohort 1 only)
7. 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
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 pervious 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
18 Years
ALL
No
Sponsors
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Memorial Sloan Kettering Cancer Center
OTHER
National Jewish Health
OTHER
Responsible Party
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Jeffrey Kern
Professor of Medicine
Locations
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National Jewish Health
Denver, Colorado, United States
The Melanoma and Skin Cancer Institute
Denver, Colorado, United States
Memorial Sloan Kettering Cancer Center
New York, New York, United States
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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ircAE HS-3411
Identifier Type: -
Identifier Source: org_study_id
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