Biomarkers Consortium - Vol-PACT: Advanced metrics and modeling with Volumetric CT for Precision Analysis of Clinical Trial results

After the investment of millions of dollars and the involvement of thousands of patients, a large proportion of Phase III solid tumor trials in cancer still fail. One theory for these failures is that some of the endpoints and related outcome measures used to judge Phase II trial results are not adequate, particularly in imaging solid tumors. Newer 3D imaging approaches to measuring tumor volume such as volumetric CT have shown promise for replacing traditional 1-D and 2-D imaging techniques. This completed pilot project led to the current Vol-PACT Phase II, which seeks to analyze volumetric CT imaging trial data contributed “in-kind” from completed industry phase II solid tumor trials to improve quantitative prediction of phase III results, including metrics of response to therapies to better predict Phase III outcomes.

Goals

  • Assess which quantitative metrics for phase II trial analysis most accurately and reliably predict phase III results across multiple treatment regimens and cancer types.
  • Study different characteristics of objective progression and their association with improved overall survival, towards the development of improved criteria for progression.
  • Quantify the added value of volumetric tumor measurement as compared to conventional cross-sectional measurement only for quantification of response and progression.
  • Study differences amongst the above analyses across different classes of systemic therapies, including immunotherapies.

Partners

Amgen, Inc.
AstraZeneca Pharmaceuticals LP
Bristol-Myers Squibb Company
Columbia University
Dana Farber Cancer Institute
Food and Drug Administration
GlaxoSmithKline
Johnson & Johnson
Merck Sharp & Dohme Corp.
Memorial Sloan Kettering Cancer Center
National Cancer Institute
Pfizer Inc
Sanofi
University of Chicago
Wyeth Nutrition

Contact

Stacey J. Adam, Ph.D., Director, Cancer; sadam@fnih.org; Dana E. Connors, Scientific Project Manager, Cancer; dconnors@fnih.org