Cancer Immunotherapy Clinical Trials: Concepts and Challenges

The Society for Immunotherapy of Cancer (SITC) is offering a two-day workshop which will outline the current challenges posed by the development of therapeutic trials in immunotherapy. Several of these questions 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. Topic driven abstracts can be submitted for consideration for an oral presentation.


+ show speakers and program
7:00 am - 8:10 am Registration
8:10 am - 8:40 am Welcome and Introduction
Samir Khleif, MD - Georgia Regents University
Howard Streicher, MD - National Institutes of Health
8:40 am - 12:00 pm Session I: Early Vaccine Clinical Trial Development
Co-Chairs:
Samir Khleif, MD - Georgia Regents University
Cornelis Melief, MD, PhD - ISA Therapeutics BV
8:40 am - 9:00 am Defining Challenges in Development of Vaccine in Early Clinical Trials
Cornelis Melief, MD, PhD - ISA Therapeutics BV
9:00 am - 9:20 am Do We Need Phase I Design for Vaccine Development and When?
Samir Khleif, MD - Georgia Regents University
9:20 am - 9:50 am Formulating Alternative Designs to Determine Dose and Schedule of Vaccine
Lawrence V. Rubinstein, PhD - National Cancer Institute
9:50 am - 10:10 am Designed/Personalized Patient Specific Product
Harpreet Singh, PhD - Immatics Biotechnologies
10:10 am - 10:30 am Refreshments and Networking
10:30 am - 11:00 am Session I: Abstract Presentations
11:00 am - 12:00 pm Panel Discussion
Samir Khleif, MD - Georgia Regents University
Cornelis Melief, MD, PhD - ISA Therapeutics BV
Lawrence V. Rubinstein, PhD - National Cancer Institute
Harpreet Singh, PhD - Immatics Biotechnologies
Craig Slingluff, MD - University of Virginia
Howard Streicher, MD - National Institutes of Health
12:00 pm - 1:00 pm Lunch Break and Networking
1:00 pm - 5:00 pm Session II: Early Immunemodulator Therapy Clinical Trial Development
Co-Chairs
Axel Hoos, MD, PhD - GlaxoSmithKline
1:00 pm - 1:20 pm Toxicity Evaluation Design for Cancer Immune Therapy
Karen Messer, PhD - University of California San Diego
1:20 pm - 1:40 pm Design of Clinical Trials Based on Molecularly Targeted End-points
Edward Korn, PhD - National Cancer Institute
1:40 pm - 2:00 pm Lessons Learned, CTLA 4PD1 AXIS Immune Tumor Response Criteria
Axel Hoos, MD, PhD - GlaxoSmithKline
2:00 pm - 2:20 pm Do We Use RECIST to Evaluate Tumor Response in Immune Therapy?
Antonio Tito Fojo, MD, PhD - National Cancer Institute
2:20 pm - 2:40 pm What Relevant In Vitro Diagnostic Multivariate Immune Monitoring Criteria Do We Use?
2:40 pm - 3:00 pm What Relevant Immune Monitoring and Correlative Study Criteria
Do We Use?
Lisa Butterfield, PhD - University of Pittsburgh Cancer Institute
3:00 pm - 3:20 pm Refreshments and Networking
3:20 pm - 4:00 pm Session II: Abstract Presentations
4:00 pm - 5:00 pm Panel Discussion
Lisa Butterfield, PhD - University of Pittsburgh Cancer Institute
Antonio Tito Fojo, MD, PhD - National Cancer Institute
Axel Hoos, MD, PhD - GlaxoSmithKline
Edward Korn, PhD - National Cancer Institute
Karen Messer, PhD - University of California San Diego
Friday, April 5, 2013
8:30 am - 8:45 am Welcome and Summary
Samir Khleif, MD - Georgia Regents University
Howard Streicher, MD - National Institutes of Health
8:45 am - 12:15 pm Session III: Immune Therapy In Combination
Co-Chairs
Patrick Hwu, MD - MD Anderson Cancer Center
F. Stephen Hodi Jr., MD - Dana-Farber Cancer Institute
8:45 am - 9:05 am The Need for Combination dnd How Do We Determine Combination
(Combinations Are Numerous, How Do We Prioritize?)
Patrick Hwu, MD - MD Anderson Cancer Center
9:05 am - 9:25 am Combination in Early Clinical Trials, Lesson Learned I
F. Stephen Hodi Jr., MD - Dana-Farber Cancer Institute
9:25 am - 9:45 am Why Do We Need A New Trial Paradigm for Combination Immune Therapy, Economic Perspective
David Dilts, PhD, MBA, CMA - Oregon Health & Science University
9:45 am - 10:05 am New Designs For Efficient Combination Immune Therapies
Richard Simon, DSc - National Cancer Institute
10:05 am - 10:25 am Beyond The 3+3 Method in Phase I Oncology of Combination of Two Agents
10:25 am - 10:45 am Refreshments and Networking
10:45 am - 11:15 am Panel Discussion
David Dilts, PhD, MBA, CMA - Oregon Health & Science University
F. Stephen Hodi Jr., MD - Dana-Farber Cancer Institute
Patrick Hwu, MD - MD Anderson Cancer Center
Richard Simon, DSc - National Cancer Institute
11:15 am - 12:15 pm Short Talk Presentation
NCI Funded Cancer Immunotherapy Trials Network
Martin Cheever, MD - Fred Hutchinson Cancer Research Center
12:15 pm - 1:00 pm Lunch Break and Networking
1:00 pm - 1:20 pm Adoptive Immune Therapy, Lesson Learned in Trial Design
Steven Rosenberg, MD, PhD - National Cancer Institute
9:00 am - 12:00 pm Session IV: Preclinical Development
Co-Chairs
Jeffrey Schlom, PhD - National Cancer Institute
1:20 pm - 1:40 pm Translation of Biologic Science into Clinical Trials
Jeffrey Schlom, PhD - National Cancer Institute
1:40 pm - 2:00 pm How Well Preclinical Model Predicts Toxicity and Efficacy
Bernard Fox, PhD - Earle A. Chiles Research Institute
2:00 pm - 2:20 pm What Is Needed for Toxicity and Responses Purposes in Vaccine
2:20 pm - 2:40 pm Can Vaccine Dose Be Determined By Preclinical Models?
Craig Slingluff, MD - University of Virginia
2:40 pm - 3:00 pm Refreshments and Networking
3:20 pm - 4:00 pm Reimbursement Challenges and Solutions
4:00 pm - 5:00 pm Summary and Conclusion
Thomas Davis, MD - Celldex Therapeutics, Incorporated*
Samir Khleif, MD - Georgia Regents University*
Howard Streicher, MD - National Institutes of Health*

4 Apr - 5 Apr 2013
Bethesda
United States of America
meeting website