What is this study trying to find out about immunotherapy side effects?

This study is collecting research data and samples to better understand side effects caused by immunotherapy in cancer patients. Researchers want to learn how to predict, prevent, and treat these immune-related adverse events. The study is led by the Alliance for Clinical Trials in Oncology to support future research efforts.

Who may be eligible for this malignancy clinical trial?

Adults who have received immuno-oncology therapy and experienced certain immune-related side effects or rare infections may be eligible. This study accepts all genders and excludes COVID-19 infections. Please review eligibility criteria for more details.

Is there any cost to participate in this malignancy clinical trial?

Study-related care, including sample collection and medical record review, is provided at no cost. However, personal travel or other expenses may vary and are not guaranteed to be covered. Participants should consider their own costs when joining.

Actively Recruiting

All Genders

ID04242095

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

Led by Alliance for Clinical Trials in Oncology · Updated on 2026-06-02

240

Participants Needed

626

Research Sites

N/A

Total Duration

AI-Summary

What this Trial Is About

This research aims to collect data and samples from patients who experience side effects from immunotherapy used in cancer treatment. The goal is to better understand, predict, prevent, and treat these immune-related side effects, including serious adverse events, rare infections, or accelerated tumor growth. This observational study is led by the Alliance for Clinical Trials in Oncology and focuses on patients treated with immuno-oncology therapies who have experienced significant immune-related adverse events. Participants provide tissue and blood samples, with optional stool samples for those experiencing colitis, within 72 hours of confirming a serious immune-related adverse event and again one month later. The study also includes a review of patients medical records for up to one year. This approach helps establish a national biorepository of biospecimens and clinical data for future research. During the study, participants will undergo sample collection at two time points and have their medical history reviewed over a year. Researchers will monitor the establishment of the biorepository and collect clinical data to support future studies. This process aims to improve knowledge about immune-related side effects from immunotherapy and contribute to better patient care over time.

CONDITIONS

Brief Title

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

Who Can Participate

All Genders

Eligibility Criteria

You may qualify if you...

Received a regimen containing one or more immuno-oncology therapeutics
Experienced one or more serious (Grade 3-4) immune-related adverse events
Experienced one or more Grade 2 dermatologic or rheumatologic immune-related adverse events
Diagnosed with a rare infection (e.g., fungal or mycobacterial) after starting immuno-oncology treatment
Experienced hyperprogression (accelerated tumor growth)
Not previously registered to this study

You will not qualify if you...

Diagnosis of SARS-CoV-2 (COVID-19) infection

Research Team

David Kozono, MD, PhD

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