Status:
UNKNOWN
Identification of Pathways to Mitigate Immune-Related Adverse Events With Cancer Immunotherapy
Lead Sponsor:
National Jewish Health
Collaborating Sponsors:
Memorial Sloan Kettering Cancer Center
Conditions:
Cancer
Eligibility:
All Genders
18+ years
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 cu...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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
Key Trial Info
Start Date :
June 1 2020
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
February 1 2025
Estimated Enrollment :
238 Patients enrolled
Trial Details
Trial ID
NCT04283539
Start Date
June 1 2020
End Date
February 1 2025
Last Update
November 13 2023
Active Locations (3)
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1
National Jewish Health
Denver, Colorado, United States, 80206
2
The Melanoma and Skin Cancer Institute
Denver, Colorado, United States, 80206
3
Memorial Sloan Kettering Cancer Center
New York, New York, United States, 10065