Maximizing the Value of Phase III Trials in Immuno-Oncology

Maximizing the value of phase III trials in immuno-oncology: A checklist from the Society for Immunotherapy of Cancer (SITC)

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Phase III trials are how new treatments for cancer demonstrate benefit and establish their place in the treatment paradigm to offer improved outcomes for patients. These trials are time- and resource-intensive, involving hundreds of patients and spanning multiple years. As many as half of phase III trials in oncology are unsuccessful, representing substantial losses in terms of monetary investment and opportunity for patients to receive a more effective treatment for their disease.

No uniform method has been established to predict the probability of success for individual clinical trials. To help identify clinical trials with a high likelihood of offering benefit to patients, the Society for Immunotherapy of Cancer (SITC) brought together a team of experts in immuno-oncology to create a conceptual framework for potential value in phase III studies evaluating immunotherapy combinations. The framework, put forth as a checklist for the oncology community, is published in a new manuscript, “Maximizing the value of phase III trials in Immuno-oncology:  A checklist from the Society for Immunotherapy of Cancer (SITC),” now available in the Journal for ImmunoTherapy of Cancer, the society’s open-access, peer-reviewed online journal.

SITC’s checklist provides a simple framework to evaluate the mechanism and biology, early clinical evidence, trial design, and potential for impact of planned phase III trials evaluating immunotherapy combinations. The checklist places the highest priority on clinical data, and in cases where this is lacking, evidence of anti-tumor activity in multiple pre-clinical models, a well-defined immune mechanism of action, and a predictive biomarker to allow for selection of patients are strongly encouraged.

Framework for Evaluating Phase III Trials


Manuscript Development Group

  • Michael B. Atkins, MD - Chair
    Georgetown Lombardi Comprehensive Cancer Center
  • Mario Sznol, MD - Chair
    Yale School of Medicine
  • Paolo A. Ascierto, MD
    Istituto Nazionale Tumori IRCCS Fondazione 'G. Pascale'
  • Michael R. Bishop, MD
    University of Chicago
  • Daniel S. Chen, MD, PhD
    Engenuity Life Sciences
  • Madhav Dhodapkar, MD
    Winship Cancer Institute at Emory University
  • Leisha A. Emens, MD, PhD
    UPMC Hillman Cancer Center
  • Marc S. Ernstoff, MD
    National Cancer Institute
  • Robert L. Ferris, MD
    UPMC Hillman Cancer Center
  • Tim F. Greten, MD
    National Cancer Institute
  • James L. Gulley, MD, PhD, FACP
    National Cancer Institute
  • Roy S. Herbst, MD, PhD
    Yale Cancer Center
  • Rachel W. Humphrey, MD
    Normunity, Inc.
  • James Larkin, MD
    Royal Marsden Hospital
  • Kim A. Margolin, MD, FASCO
    St. John’s Cancer Institute
  • Luca Mazzarella, MD, PhD
    European Institute of Oncology
  • Suresh S. Ramalingam, MD
    Emory University School of Medicine
  • Meredith M. Regan, ScD
    Dana-Farber Cancer Institute
  • Brian I. Rini, MD
    Vanderbilt University Medical Center

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