Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 2:04 PM
Ignite Modification Date:
2025-12-24 @ 2:04 PM
NCT ID:
NCT04242095
Eligibility Criteria:
Inclusion Criteria:
* Received a regimen containing one or more immuno-oncology therapeutics
* Must have experienced one or more of the following:
* One or more serious (Grade 3-4) AEs that are likely immune-related
* One or more Grade 2 dermatologic or rheumatologic AEs that are likely immune-related
* Diagnosis of a rare infection, e.g., fungal or mycobacterial, after starting IO treatment
\*\* Note: Diagnosis of SARS-CoV-2 (COVID-19) is excluded
* Hyperprogression. Image submission for patients experiencing hyperprogression is required. For assistance in determining hyperprogression for purposes of eligibility, institutions may contact the study chair and submit images for central review
* Has not previously been registered to this study
Healthy Volunteers:
False
Sex:
ALL
Study:
NCT04242095
Study Brief:
Protocol Section:
NCT04242095