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. Additional funding has been provided to include a radiomic outcomes clinical correlation with machine learning capabilities to augment metric development.

To date the project has received funding from seven industry partners. Five companies have provided data from ten 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.


  • 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.

Results & Accomplishments

Scientific Publications

Enhanced Detection of Treatment Effects on Metastatic Colorectal Cancer with Volumetric CT Measurements for Tumor Burden Growth Rate Evaluation  Michael L. Maitland1,2, Julia Wilkerson3 , Sanja Karovic1 , Binsheng Zhao4 , Jessica Flynn5 , Mengxi Zhou3 , Patrick Hilden5 , Firas S. Ahmed4 , Laurent Dercle4 , Chaya S. Moskowitz5 , Ying Tang6 , Dana E. Connors7 , Stacey J. Adam7 , Gary Kelloff7 , Mithat Gonen5 , Tito Fojo3 , Lawrence H. Schwartz4 , and Geoffrey R. Oxnard8. Clin Cancer Res 2020;26:6464–74. September 28, 2020. 

Comparing RECIST 1.1 and iRECIST in advanced melanoma patients treated with pembrolizumab in a Phase 2 clinical trial. Firas S. Ahmed, Laurent Dercle, Gregory V. Goldmacher, Hao Yang, Dana Connors, Ying Tang, Sanja Karovic, Binsheng Zhao, Richard D. Carvajal, Caroline Robert, Michael L.Maitland, Geoffrey R. Oxnard, and Lawrence H. Schwartz. European Radiology September 30, 2020. 

Vol-PACT: A Foundation for the NIH Public-Private Partnership That Supports Sharing of Clinical Trial Data for the Development of Improved Imaging Biomarkers in Oncology. Laurent Dercle, Dana E. Connors, Ying Tang, Stacey J. Adam, Mithat Gönen, Patrick Hilden, Sanja Karovic, Michael Maitland, Chaya S. Moskowitz, Gary Kelloff, Binsheng Zhao, Geoffrey R. Oxnard, and Lawrence H. Schwartz. JCO Clinical Cancer Informatics 2018 :2, 1-12



Public-Sector Partners
Memorial Sloan Kettering Cancer Center
National Cancer Institute
U.S. Food and Drug Administration

Private-Sector Partners
Amgen, Inc.*
Boehringer Ingelheim*
EMD Serono*
Genentech, a member of the Roche Group*
Merck Sharp & Dohme Corp.*
Novartis Pharmaceuticals Corporation*
Regeneron Pharmaceuticals, Inc.*
Takeda Pharmaceuticals International, Inc.*

Academic Partners
Columbia University
Dana-Farber Cancer Institute
Inova Center for Personalized Health and Schar Cancer Institute

*Provides financial or in-kind support for this program.

FNIH Contacts

Stacey J. Adam, Ph.D., Director, Cancer;
Dana E. Connors, Senior Project Manager, Cancer;