Collecting data and samples from patients with immunotherapy side effects

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

* PRE-REGISTRATION ELIGIBILITY CRITERIA: Planning to receive a regimen containing one or more IO therapeutics
* PRE-REGISTRATION ELIGIBILITY CRITERIA: Has not previously been treated with CTLA-4, PD-1 or PD-L1 inhibitors
* PRE-REGISTRATION ELIGIBILITY CRITERIA: Willing and able to provide baseline blood and stool samples
* REGISTRATION ELIGIBILITY CRITERIA: Received a regimen containing one or more immuno-oncology therapeutics

  * Must have received one or more IO therapeutics
  * In addition to one or more IO therapeutics, patients may also have received other therapeutics such as chemotherapy, hormonal or targeted therapy, as long as these are reported
* REGISTRATION ELIGIBILITY CRITERIA: Must have experienced one or more of the following:

  * One or more serious (grade 3-54) AEs that are likely immune-related. AEs included in Common Terminology Criteria for Adverse Events (CTCAE) version (v.) 5.0 that may be immune-related

    \*\* Patients who experience only hematologic cytopenia(s) who have received cytotoxic therapies, e.g., chemotherapy, within 60 days prior to registration should be excluded
  * One or more grade 2 dermatologic, endocrine (except diabetes/hyperglycemia) or rheumatologic AEs that are likely immune-related. AEs included in CTCAE v. 5.0 that may be 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
* REGISTRATION ELIGIBILITY CRITERIA: Has not previously been registered to this study \* The same patient cannot be enrolled more than once to this study due to development of subsequent irAEs

Where it's running

• Anchorage Associates in Radiation Medicine
  Anchorage, Alaska, United States Recruiting
• Alaska Breast Care and Surgery LLC
  Anchorage, Alaska, United States Recruiting
• Alaska Oncology and Hematology LLC
  Anchorage, Alaska, United States Recruiting
• Alaska Women's Cancer Care
  Anchorage, Alaska, United States Recruiting
• Katmai Oncology Group
  Anchorage, Alaska, United States Recruiting
• Providence Alaska Medical Center
  Anchorage, Alaska, United States Recruiting

+580 more sites. See ClinicalTrials.gov for the full list.

Study contacts

• Study coordinator: David Kozono, MD, PhD
• Email: dkozono@bwh.harvard.edu
• Phone: 617-632-5734

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.