E-News - January 2020
Spotlight on Alliance Trials

ALLIANCE TO ESTABLISH NATIONAL BIOREPOSITORY TO ADVANCE STUDY OF IMMUNE-RELATED SIDE EFFECTS

Immunotherapy drugs called immune checkpoint inhibitors have generally been well tolerated by most patients; however, a minority of patients, around 5-10 percent, experience one or more severe immune-related adverse events (irAEs) that can involve diverse organs including the heart, lungs, liver, intestines, kidneys, muscles, skin, brain, and nerves. On occasion, these rare but serious side effects that occur in response to immune activation can be rapidly fatal. Because of the relatively low occurrence and wide variety of irAEs, the establishment of an efficient centralized repository for acquisition and organized distribution of well-annotated biospecimens is vital. Once samples are collected, future translational studies will improve the scientific community’s understanding of the molecular pathogenesis and treatment of these significant toxicities. To this end, the Alliance for Clinical Trials in Oncology through its Immuno-Oncology Committee has just launched Alliance A151804, Establishment of a national biorepository to advance studies of immune-related adverse events, led by David Kozono, MD, PhD, of Brigham and Women’s Hospital. The Alliance is partnering with other networks within the National Cancer Institute’s National Clinical Trials Network, including ECOG-ACRIN Cancer Research Group (PI: John Kirkwood, MD, University of Pittsburgh), NRG Oncology (PI: Jarushka Naidoo, MBBCh, Johns Hopkins University), and SWOG Cancer Research Network (PI: Gary Lyman, MD, PhD, Washington University), to collect blood and tissue samples from patients at the time they experience these toxicities. This effort affords the Alliance and its partners the unique opportunity to harmonize biospecimen acquisition for impactful immuno-oncology research.

Alliance A151804 is the first trial activated by the newly formed Alliance Immuno-Oncology (IO) Committee chaired by Dr. Kozono, Andrew B. Nixon, PhD, Professor of Medicine and Director of the Phase I Biomarker Laboratory at Duke Cancer Institute, and Elizabeth Mittendorf, MD, PhD, Rob and Karen Hale Distinguished Chair in Surgical Oncology and Director of the Breast Immuno-Oncology Program at Dana-Farber/Brigham and Women’s Cancer Center. Formed in the wake of an unprecedented number of new immunotherapy agents being investigated in clinical trials, the committee’s goal is to provide IO expertise to the Alliance. It is comprised of a multi-disciplinary team of clinicians and researchers who seek to optimize IO trials and biomarkers. It serves an advisory role to disease site committees developing study concepts featuring IO agents to provide input related to both trial design and incorporation of immune correlates. The committee also will propose and conduct trials that investigate novel immunotherapeutic agents or strategies, particularly those that cross disease sites or address orphan interactions. Importantly, the IO committee will work to develop best-in-class approaches to harmonize biospecimen collection, processing and storage for present and future IO research (as in the case of the new Alliance 151804 trial), and interface with reference labs including the Cancer Immune Monitoring and Analysis Centers (CIMACs).

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Study Chair: David Kozono, MD, PhD, Dana-Farber/Brigham and Women's Hospital
E-mail: dkozono@lroc.harvard.edu
Activated: 1/31/2020  | Status: Now recruiting participants
CT.gov Link: http://bit.ly/AllianceA151804