IRB #

STUDY00024032

Title

[NCI CIRB] S2013, IMMUNE CHECKPOINT INHIBITOR TOXICITY (I-CHECKIT): A PROSPECTIVE OBSERVATIONAL STUDY

Principal Investigator

Eric Roeland

Study Purpose

The purpose of this study is to see if we can predict who is likely to have serious side effects when treated with immunotherapy for cancer. Immunotherapy is the type of treatment that helps your immune system fight cancer. In the future, this information can help participants and their doctors make better decisions about cancer treatments.

Medical Condition(s)

ICI-based therapy for solid tumor malignancy

Eligibility Criteria

1- Must be planning to receive ICI-based therapy for a solid tumor malignancy

2- ICI-based therapy must have completed within 180 days prior to registration

3- Must not have discontinued any prior ICI-based therapy because of an irAE

4- Must not have received chemotherapy, biologic, or targeted-therapy within 21 days prior to registration

5- Must not be planning to receive ICI-based therapy in combination with chemotherapy or any other non-ICI therapy for treatment of their cancer.

6- Must be planning to begin standard of care ICI-based therapy within 3 calendar days after registration

7- Must have recovered from side effects of prior therapy to the following standards per treating physician’s discretion:
• < = Grade 1 for any non-hematologic side effects (excluding neuropathy and alopecia); lab-related parameters of liver and renal function will be considered at the discretion of the treating physician)
• < = Grade 2 for neuropathy and/or alopecia
• Grade 3 or less for any hematologic side effects

Age Range

18 - 99

Healthy Volunteers Needed

No

Duration of Participation

12 months

Minors Included

No

Contact

Knight Cancer Institute Clinical Trials
trials@ohsu.edu
503 494-1080

Sponsor

SWOG

Recruitment End

01/31/2024

Compensation Provided

No


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