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

Vol-PACT Phase II is a three year research partnership designed to develop new methods for analyzing digital images to more accurately measure cancer response and progression. Following a one year Biomarkers Consortium pilot that established feasibility of the project, Vol-PACT is the first of its kind to procure imaging data from multiple completed, pharmaceutical industry-sponsored, phase II/III clinical trials to identify novel drug response metrics. The Vol-PACT project team will analyze the imaging data from these trials to measure characteristics of cancer progression and to generate potential biomarkers. The project will compare the new biomarkers to RECIST and irRECIST, the current image analysis standards used for therapies that target specific genes and proteins (targeted therapies), as well as those that stimulate immune response (immunotherapies). A focus on trials investigating immunotherapy and combination therapy will be used to address the present inability to predict their efficacy in many cancer types.

To date the project has received funding from five industry partners. Four companies have provided data from eight completed trials including original images and de-identified clinical reports in colorectal cancer, renal cell carcinoma, and non-small cell lung cancer. Since the project has access to multiple completed datasets, the team can rapidly develop robust imaging biomarker criteria and verify their utility in different settings and across multiple cancer types. At its close, the project is expected to review data from twelve different phase II/III trials from multiple cancer types and therapies. This work has the potential to improve the accuracy and efficiency of future clinical trials, accelerate cancer therapeutic development and allow physicians to better treat cancer patients.

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.
  • Validation of immune-RECIST (iRECIST), and development of alternate iRECIST metrics, for prediction of clinical outcomes in patients with advanced cancer receiving immune therapy.
  • Comparison of tumor measurements derived from case report forms (CRFs) with those derived directly from imaging for accurate description of response and progression kinetics in patients receiving immune therapies.

Media

Partners

Amgen, Inc.
Boehringer Ingelheim
Columbia University
Dana-Farber Cancer Institute
EMD Serono
Food and Drug Administration (FDA)
Genentech, Inc.
Inova Center for Personalized Health and Schar Cancer Institute
Memorial Sloan Kettering Cancer Center
Merck Sharp & Dohme Corp.
National Cancer Institute (NCI)
Novartis Pharmaceuticals Corporation
Regeneron Pharmaceuticals, Inc.
Sanofi
Takeda Pharmaceuticals International, Inc.

Contact

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