Establishment of a National Biorepository to Advance Studies of Immune-Related Adverse Events

  • End date
    Feb 14, 2025
  • participants needed
  • sponsor
    Alliance for Clinical Trials in Oncology
Updated on 14 October 2022
treatment regimen


This trial collects research data and samples from patients who experience immunotherapy side effects to store for use in future research studies. Studying research data and samples from patients who experience immunotherapy side effects may help researchers better understand how to predict, prevent, and treat these side effects.



To establish a national biorepository including biospecimen and clinical data collections from patients treated with immuno-oncology (IO) therapeutics who experience one or more serious (grade 3-4) immune-related adverse events (irAEs), rare infections or hyperprogression (acceleration of tumor growth).


Patients undergo collection of tissue and blood samples (and optional stool samples from patients experiencing colitis) at the time of registration (within 72 hours of confirmation of one or more severe irAEs) and at 1 month after registration. Patients' medical records are also reviewed for up to 1 year.

Condition Malignancy
Treatment medical chart review, biospecimen collection
Clinical Study IdentifierNCT04242095
SponsorAlliance for Clinical Trials in Oncology
Last Modified on14 October 2022


Yes No Not Sure

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
Diagnosis of a rare infection, e.g., fungal or mycobacterial, after starting IO treatment
One or more Grade 2 dermatologic or rheumatologic AEs that are likely immune-related
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
Note: Diagnosis of SARS-CoV-2 (COVID-19) is excluded
Has not previously been registered to this study
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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