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Research on Immunotherapy Side Effects

This study is collecting information and samples from people who have experienced side effects from immunotherapy treatments for cancer. The goal is to create a national collection of these samples and medical information. By studying these, researchers hope to better understand why these side effects happen and how to prevent or treat them in the future. You might be able to join if you've had immunotherapy and experienced certain serious side effects, or specific skin or joint side effects, or a rare infection. This study is considered successful if it successfully establishes this collection of data and samples for future research.

Study design
This is an observational study, meaning researchers will collect information and samples without giving new treatments. It aims to enroll 240 participants.
What's involved
You would have tissue, blood, and possibly stool samples collected at the start and again after one month. Your medical records would also be reviewed for up to one year.
Compensation
Not stated in the trial record.
Follow-up
Your medical records will be reviewed for up to one year after you join the study.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT04242095

Collection of Research Data and Samples From Patients Who Experience Immunotherapy Side Effects

Recruiting
Not specifiedAll AgesObservational
Alliance for Clinical Trials in Oncology
~240 participants
Updated 2026-08-05 on ClinicalTrials.gov
What's tested:Biospecimen CollectionMedical Chart Review

At a glance

Recruiting sites
394 of 625 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Establishment of a national biorepository including biospecimen and clinical data collections for future use
Measured over Up to 1 year

Conditions

Malignancy

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Where it's being run

625 sites across 44 states
Ohio65
Illinois63
Michigan49
Nevada48
Wisconsin44
Washington36
Minnesota32
Colorado30

Study leadership

  • David Kozono, MD, PhD · STUDY_CHAIR · Brigham and Women's Hospital

Who to contact

David Kozono, MD, PhD
[email protected]
617-632-5734
Email the study team

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Do you actually qualify for this trial?

Add a private profile and we'll compare every criterion below against your situation — and tell you which ones are met, uncertain, or excluding.

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Eligibility criteria

Inclusion

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
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

What this trial measures

  • Establishment of a national biorepository including biospecimen and clinical data collections for future useUp to 1 year

    The objective of this study to establish a biorepository of biospecimen and clinical data. There is no primary clinical outcome for this study.