at San Francisco, California and other locations
study started
completion around
Principal Investigator
by Terence W. Friedlander
Headshot of Terence W. Friedlander
Terence W. Friedlander



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.

Official Title

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



To establish a national biorepository including biospecimen and clinical data collections from patients treated with immuno-oncology (IO) therapeutics who experience one or more serious (grade 3-4) immune-related adverse events (irAEs), rare infections or hyperprogression (acceleration of tumor growth).


Patients undergo collection of tissue and blood samples (and optional stool samples from patients experiencing colitis) at the time of registration (within 72 hours of confirmation of one or more severe irAEs) and at 1 month after registration. Patients' medical records are also reviewed for up to 1 year.


Malignancy, Neoplasms, Biospecimen Collection, Medical Chart Review


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


  • Zuckerberg San Francisco General Hospital accepting new patients
    San Francisco California 94110 United States
  • Bay Area Breast Surgeons Inc accepting new patients
    Emeryville California 94608 United States
  • Epic Care Partners in Cancer Care accepting new patients
    Emeryville California 94608 United States
  • Bay Area Tumor Institute accepting new patients
    Oakland California 94609 United States
  • Contra Costa Regional Medical Center accepting new patients
    Martinez California 94553-3156 United States
  • Epic Care Cyberknife Center accepting new patients
    Walnut Creek California 94597 United States
  • Epic Care-Dublin accepting new patients
    Dublin California 94568 United States

Lead Scientist at UCSF

  • Terence W. Friedlander
    I am a clinical and translational medical oncologist with a focused on urologic cancers, specifically cancers of the bladder, prostate, and kidney. I am also the Chief of the ZSFG Division of Hematology and Oncology. My research is focused on understanding the basic biology of urologic and other malignancies and in developing novel therapeutic ways to treat disease.


accepting new patients
Start Date
Completion Date
Alliance for Clinical Trials in Oncology
Study Type
Expecting 240 study participants
Last Updated