Establishment of a National Biorepository to Advance Studies of Immune-Related Adverse Events (A151804)

Overview

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.

Key Inclusion Criteria

For a patient to be eligible for participation in this study, all of the following criteria must apply.

• 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

Sponsor(s)

Alliance for Clinical Trials in Oncology

Learn More

To learn more, visit ClinicalTrials.Gov