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Collecting data and samples from patients with immunotherapy side effects

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

Alliance for Clinical Trials in Oncology · NCT04242095

This study is collecting blood, tissue, and stool samples from patients who have serious side effects from immunotherapy to help understand and improve how to manage these reactions.

Quick facts

Study typeObservational
Enrollment240 (estimated)
SexAll
SponsorAlliance for Clinical Trials in Oncology (other)
Drugs / interventionsimmunotherapy
Locations626 sites (Anchorage, Alaska and 625 other locations)
Trial IDNCT04242095 on ClinicalTrials.gov

What this trial studies

This observational trial aims to establish a national biorepository that collects biospecimens and clinical data from patients who experience serious immune-related adverse events (irAEs) after receiving immuno-oncology therapies. Patients will provide tissue and blood samples, and optional stool samples if they experience colitis, within 72 hours of severe irAE confirmation and again one month later. Additionally, their medical records will be reviewed for up to one year to gather comprehensive data on these side effects. The goal is to enhance understanding of how to predict, prevent, and treat these adverse effects.

Who should consider this trial

Good fit: Ideal candidates are patients who have received immuno-oncology treatments and experienced serious immune-related adverse events or rare infections.

Not a fit: Patients who have not experienced serious immune-related adverse events or those diagnosed with COVID-19 will not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to improved management and treatment strategies for patients experiencing severe side effects from immunotherapy.

How similar studies have performed: Other studies have shown success in collecting data on immunotherapy side effects, making this approach a continuation of valuable research.

Eligibility criteria

Show full inclusion / exclusion 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

Where this trial is running

Anchorage, Alaska and 625 other locations

+576 more sites — see ClinicalTrials.gov for the full list.

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.

View on ClinicalTrials.gov →

Conditions: Malignancy

Last reviewed 2026-05-15 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.