SITC Archive Library

2013 CICL: Concepts and Challenges 

03-02-2018 10:47

Cancer immunotherapy Clinical Trials: Concepts and Challenges
April 4-5, 2013
National Institutes of Health Campus
Bethesda, MD

Program Organizers
Thomas A. Davis, MD - Celidex therapeutics, Incorporated
Samir N. Khleif, Md - Georgia Regents University
Howard Streicher, MD - National Institutes of Health
David F. Stroncek, MD - National Institutes of Health

Program Summary
This two-day workshop will outline the current challenges posed by the development of therapeutic trials in immunotherapy. Several of these trials will be examined in greater detail, including preclinical testing requirements for clinical development, innovative clinical trial design, appropriate patient selection, end point determination, and developing combination therapies to improve long term disease management and survival. Accelerating anticancer agent development, validation and approvals will also be discussed. It is expected that, at the conclusion of the workshop, participants and speakers will have developed a framework or recommendations on how to design better clinical trials. 

Target Audience
The target audience for this program includes academic researchers, industry and biotech company representatives, preclinical pharmaceutical developers, oncologists, investors/venture capitalists, biopharmaceutical consultants, and health care professionals engaged in clinical trials of cancer immunotherapy.

Presentations and video recordings are available based on permission from presenters.


#Biomarkers #ClinicalTrials #BreastCancers #ProstateCancer #PresentationSlides #CombinationTherapy #ImmuneCheckpointInhibitors #TherapeuticAntibodies #Vaccines #AlliedHealth #Clinician #Industry #Oncologist #Researcher #2013 #RenalCellCarcinoma #Melanoma #BrainCancers #Leukemia #Lymphoma #AdoptiveCellTherapy

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Attachment(s)
pdf file
Welcome and Introductions   272 KB   1 version
Uploaded - 03-02-2018
Meeting: Cancer Immunotherapy Clinical Trials Network: Concepts and Challenges; Presentation: Welcome and Introduction; Presenter: Howard Streicher, MD - National Institutes of Health; Date: Thursday, April 4, 2013
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Defining Challenges in Development of Vaccine in Early Cl...   475 KB   1 version
Uploaded - 03-02-2018
Meeting: Cancer Immunotherapy Clinical Trials Network: Concepts and Challenges; Session I: Early Vaccine Clinical Trial Development; Presentation: Defining Challenges in Development of Vaccine in Early Clinical Trials; Presenter: Howard Streicher, MD - National Institutes of Health; Date: Thursday, April 4, 2013
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Do We Need Phase I Design for Vaccine Development and When   322 KB   1 version
Uploaded - 03-02-2018
Meeting: Cancer Immunotherapy Clinical Trials Network: Concepts and Challenges; Session I: Early Vaccine Clinical Trial Development; Presentation: Do We Need Phase I Design for Vaccine Development and When; Presenter: Samir N. Khleif, MD - Georgia Regents University; Date: Thursday, April 4, 2013
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From off the Shelf to Actively Personalized: Cancer Vacci...   1.37 MB   1 version
Uploaded - 03-02-2018
Meeting: Cancer Immunotherapy Clinical Trials Network: Concepts and Challenges; Session I: Early Vaccine Clinical Trial Development; Presentation: From off the Shelf to Actively Personalized: Cancer Vaccines in the Era of Biomarkers; Presenter: Harpreet Singh, PhD - Immatics Biotechnologies; Date: Thursday, April 4, 2013
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Early Therapeutic Cancer Vaccine Clinical Trial Development   609 KB   1 version
Uploaded - 03-02-2018
Meeting: Cancer Immunotherapy Clinical Trials Network: Concepts and Challenges; Session I: Abstract Presentations; Presentation: Early Therapeutic Cancer Vaccine Clinical Trial Development; Presenter: Robert G. Petit, PhD - Advaxis; Date: Thursday, April 4, 2013
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Broad Spectrum Lung Cancer Stem Cell Vaccine   225 KB   1 version
Uploaded - 03-02-2018
Meeting: Cancer Immunotherapy Clinical Trials Network: Concepts and Challenges; Session I: Abstract Presentationst; Presentation: Broad Spectrum Lung Cancer Stem Cell Vaccine; Presenter: Kavitha Yaddanapudi, PhD - University of Louisville; Date: Thursday, April 4, 2013
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Phase I Dose Escalation Trial MVA-BN-PRO in Men with Non-...   907 KB   1 version
Uploaded - 03-02-2018
Meeting: Cancer Immunotherapy Clinical Trials Network: Concepts and Challenges; Session I: Abstract Presentations; Presentation: Phase I Dose Escalation Trial MVA-BN-PRO in Men with Non-Metastatic Castration Resistant Prostate Cancer; Presenter: Fatema A. Legrand, PhD - BN ImmunoTherapeutics; Date: Thursday, April 4, 2013
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Design of Clinicial Trials Based on Molecularly Targeted ...   74 KB   1 version
Uploaded - 03-02-2018
Meeting: Cancer Immunotherapy Clinical Trials Network: Concepts and Challenges; Session II: Early Immunemodulator Therapy Clinical Trail Development; Presentation: Design of Clinical Trials Based on Molecularly Targeted End-Points; Presenter: Edward Korn, PhD - National Cancer Institute; Date: Thursday, April 4, 2013
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Toxicity Evaluation Design for Cancer Immune Therapy   547 KB   1 version
Uploaded - 03-02-2018
Meeting: Cancer Immunotherapy Clinical Trials Network: Concepts and Challenges; Session II: Early Immunemodulator Therapy Clinical Trail Development; Presentation: Toxicity Evaluation Design for Cancer Immune Therapy; Presenter: Karen Messer, PhD - University of California, San Diego; Date: Thursday, April 4, 2013
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Sorafenib in RCC (TARGET Trial) A Disease-Stabilizing Agent   4.09 MB   1 version
Uploaded - 03-02-2018
Meeting: Cancer Immunotherapy Clinical Trials Network: Concepts and Challenges; Session II: Early Immunemodulator Therapy Clinical Trail Development; Presentation: Sorafenib in RCC (TARGET Trial) A Disease-Stabilizing Agent; Presenter: Antonio Tito Fojo, MD, PhD - National Cancer Institute; Date: Thursday, April 4, 2013
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What Relevant in vitro Diagnostic Multivariate Immune Mon...   812 KB   1 version
Uploaded - 03-02-2018
Meeting: Cancer Immunotherapy Clinical Trials Network: Concepts and Challenges; Session II: Early Immunemodulator Therapy Clinical Trail Development; Presentation: What Relevant in vitro Diagnostic Multivariate Immune Monitoring Criteria Do We Use; Presenter: Lisa H. Butterfield, PhD - University of Pittsburgh Cancer Institute; Date: Thursday, April 4, 2013
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Restoring Immune Function to Tumor-Specific CD4+ T Cells ...   1.09 MB   1 version
Uploaded - 03-02-2018
Meeting: Cancer Immunotherapy Clinical Trials Network: Concepts and Challenges; Session II: Abstract Presentations; Presentation: Restoring Immune Function to Tumor-Specific CD4+ T Cells During Recurrence of Melanoma; Presenter: Paul A. Antony, MD - University of Maryland; Date: Thursday, April 4, 2013
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The Need for Combination and How Do We Determine Combinat...   1.80 MB   1 version
Uploaded - 03-02-2018
Meeting: Cancer Immunotherapy Clinical Trials Network: Concepts and Challenges; Session III: Immune therapy in Combinations; Presentation: The Need for Combination and How Do We Determine Combination (Combinations Are Numerous, How Do We Prioritize?); Presenter: Patrick Hwu, MD - MD Anderson Cancer Center; Date: Friday, April 5, 2013
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New Designs for Efficient Combination Immune Therapies   175 KB   1 version
Uploaded - 03-02-2018
Meeting: Cancer Immunotherapy Clinical Trials Network: Concepts and Challenges; Session III: Immune therapy in Combinations; Presentation: New Designs for Efficient Combination Immune Therapies; Presenter: Richard Simon, PhD - National Cancer Institute; Date: Friday, April 5, 2013
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Adoptive Immune Therapy: Lesson Learned in Trial Design   25.09 MB   1 version
Uploaded - 03-02-2018
Meeting: Cancer Immunotherapy Clinical Trials Network: Concepts and Challenges; Session III: Immune therapy in Combinations; Presentation: Adoptive Immune Therapy: Lesson Learned in Trial Design; Presenter: Steven A. Rosenberg. MD, PhD - National Cancer Institute; Date: Friday, April 5, 2013
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How Well Preclinical Model Predicts Toxicity and Efficacy   903 KB   1 version
Uploaded - 03-02-2018
Meeting: Cancer Immunotherapy Clinical Trials Network: Concepts and Challenges; Session IV: Biology and Preclinical Evidence in Planning Clinical Trials; Presentation: How Well Preclinical Model Predicts Toxicity and Efficacy; Presenter: Bernard A. Fox, PhD - Earle A. Chiles Research Institute; Date: Friday, April 5, 2013
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Patient Perspective: Cancer Immunotherapy Clinical Trials   61 KB   1 version
Uploaded - 03-02-2018
Meeting: Cancer Immunotherapy Clinical Trials Network: Concepts and Challenges; Session V: Making the System Work - Economic and Intellectual Challenges and Solutions; Presentation: Patient Perspective: Cancer Immunotherapy Clinical Trials; Presenter: Gwen Darien - The Pathways Project; Date: Friday, April 5, 2013
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Making the System Work: Economic and Intellectual Challenges   1.23 MB   1 version
Uploaded - 03-02-2018
Meeting: Cancer Immunotherapy Clinical Trials Network: Concepts and Challenges; Session V: Making the System Work - Economic and Intellectual Challenges and Solutions; Presentation: Making the System Work: Economic and Intellectual Challenges; Presenter: Martin A. Cheever, MD - Fred Hutchinson Cancer Research Center; Date: Friday, April 5, 2013
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Advancing Immunotherapy Combinations   216 KB   1 version
Uploaded - 03-02-2018
Meeting: Cancer Immunotherapy Clinical Trials Network: Concepts and Challenges; Session V: Making the System Work - Economic and Intellectual Challenges and Solutions; Presentation: Advancing Immunotherapy Combinations; Presenter: Jonathon C.A. Skipper, PhD - Ludwig Institute for Cancer Research; Date: Friday, April 5, 2013
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Immunotherapy: A Practical Perspective - A View from the ...   1.31 MB   1 version
Uploaded - 03-02-2018
Meeting: Cancer Immunotherapy Clinical Trials Network: Concepts and Challenges; Session V: Making the System Work - Economic and Intellectual Challenges and Solutions; Presentation: Immunotherapy: A Practical Perspective - A View from the Dark Side; Presenter: Thomas A. Davis, MD - Celidex Therapeutics, Inc.; Date: Friday, April 5, 2013
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Think Differently: Challenges in Immunotherapy   1.36 MB   1 version
Uploaded - 03-02-2018
Meeting: Cancer Immunotherapy Clinical Trials Network: Concepts and Challenges; Session V: Making the System Work - Economic and Intellectual Challenges and Solutions; Presentation: Think Differently: Challenges in Immunotherapy; Presenter: Daniel S. Chen, MD, PhD - Genentech; Date: Friday, April 5, 2013