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SITC 2018 Pre-Conference Program: FDA and SITC Co-Sponsored Workshop: Immune-modified Response Criteria in Cancer Immunotherapy Clinical Trials 

11-29-2018 15:58

The Society for Immunotherapy of Cancer (SITC) hosted the "Pre-Conference Program: FDA and SITC Co-Sponsored Workshop - Immune-modified Response Criteria in Cancer Immunotherapy Clinical Trials" during the SITC 2018 Annual Meeting on November 8, 2018. Available here are the presentation slides and video from the session.

Program Organizers

  • Michael B. Atkins, MD – Georgetown-Lombardi Comprehensive Cancer Center
  • Howard L. Kaufman, MD, FACS – Replimune Group Inc.
  • Samir N. Khleif, MD – Georgetown University
  • Ke Liu, MD, PhD – CBER, FDA
  • Marc Theoret, MD – Office of Hematology and Oncology Products, FDA

Program Summary

This free workshop was intended to identify best practices for design, conduct, data collection, and analysis of clinical trials evaluating tumor measurement based efficacy endpoints for cancer immunotherapeutics and to engage with leaders in academia, industry, international regulatory, and patient groups. Numerous studies have been reported in the literature in an effort to improve upon conventional response criteria for tumor measurement based efficacy endpoints for cancer immunotherapeutics as conventional response criteria may not fully capture the benefit of this product class. This workshop evaluated current practices and identified opportunities to advance strategies that can provide rigorous tumor measurement-based endpoint data—accounting for the unique mechanism of action of cancer immunotherapeutics—suitable to support regulatory, payer, clinician, and patient decision making.

Disclaimer: Due to the rapidly-evolving field of cancer immunotherapy, some of the content on this page may be out of date. For current information from SITC on cancer immunotherapy, scroll down to view Related Entries and Links.

#ClinicalTrials#GastrointestinalCancers#Melanoma#NonSmallCellLungCancer
#RenalCellCarcinoma#PresentationSlides#Video#AnnualMeeting#SITC
#AdverseEvents#CombinationTherapy#Atezolizumab#ImmuneCheckpointInhibitors
#Pembrolizumab#Pharmacist#Industry#AlliedHealth#Researcher#2018

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"Pseudoprogression and current clinical challenges in the...   1.61 MB   1 version
Uploaded - 11-29-2018
Meeting: SITC 33 Annual Meeting: Session: FDA/SITC Co-Sponsored Workshop: Immune-modified Response Criteria in Cancer Immunotherapy Clinical Trials Workshop; Session I: Pseudoprogression with Immuno-oncology Therapeutics - Current Challenges with Evaluation: Presenter: Kim Margolin, MD – City of Hope; Date: November 8, 2018
 
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mp4 file
"Pseudoprogression and current clinical challenges in the...   267.92 MB   1 version
Uploaded - 12-03-2018
Meeting: SITC 33 Annual Meeting; Session: FDA/SITC Co-Sponsored Workshop: Immune-modified Response Criteria in Cancer Immunotherapy Clinical Trials Workshop; Session I: Pseudoprogression with Immuno-oncology Therapeutics - Current Challenges with Evaluation: Presenter: Kim Margolin, MD – City of Hope; Date: November 8, 2018
 
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pdf file
"Immune-Modified Response Criteria in Clinical Developmen...   631 KB   1 version
Uploaded - 12-12-2018
Meeting: SITC 33 Annual Meeting; Session: FDA/SITC Co-Sponsored Workshop: Immune-modified Response Criteria in Cancer Immunotherapy Clinical Trials Workshop; Session I: Pseudoprogression with Immuno-oncology Therapeutics - Current Challenges with Evaluation: Presenter: Sanjay Goel, MD – Montefiore Medical Center; Date: November 8, 2018
 
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mp4 file
"Immune-Modified Response Criteria in Clinical Developmen...   212.98 MB   1 version
Uploaded - 12-12-2018
Meeting: SITC 33 Annual Meeting; Session: FDA/SITC Co-Sponsored Workshop: Immune-modified Response Criteria in Cancer Immunotherapy Clinical Trials Workshop; Session I: Pseudoprogression with Immuno-oncology Therapeutics - Current Challenges with Evaluation: Presenter: Sanjay Goel, MD – Montefiore Medical Center; Date: November 8, 2018
 
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pdf file
"Clinical Trial Endpoints Considerations for Evaluating E...   2.90 MB   1 version
Uploaded - 11-29-2018
Meeting: SITC 33 Annual Meeting; Session: FDA/SITC Co-Sponsored Workshop: Immune-modified Response Criteria in Cancer Immunotherapy Clinical Trials Workshop; Session II: Evaluating Surrogate Endpoints for IO Drug Development: “New and renewed” Concepts and Perspectives: Presenter: David McDermott, MD – Beth Israel Deaconess Medical Center; Date: November 8, 2018
 
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mp4 file
"Clinical Trial Endpoints Considerations for Evaluating E...   222.02 MB   1 version
Uploaded - 12-03-2018
Meeting: SITC 33 Annual Meeting; Session: FDA/SITC Co-Sponsored Workshop: Immune-modified Response Criteria in Cancer Immunotherapy Clinical Trials Workshop; Session II: Evaluating Surrogate Endpoints for IO Drug Development: “New and renewed” Concepts and Perspectives: Presenter: David McDermott, MD – Beth Israel Deaconess Medical Center; Date: November 8, 2018
 
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