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Neoadjuvant Therapy for Melanoma: A U.S. Food and Drug Administration—Melanoma Research Alliance Public Workshop

Kristen L. Mueller, Marc R. Theoret, Steven J. Lemery, Laleh Amiri-Kordestani, Charlotte E. Ariyan, Michael B. Atkins, Donald A. Berry, Christian U. Blank, Angela M. DeMichele, Patrick M. Forde, Nageatte Ibrahim, Patricia Keegan, Tara C. Mitchell, Rebecca A. Moss, Caroline Robert, Rajeshwari Sridhara, Janis M. Taube, Michael T. Tetzlaff, Jennifer A. Wargo, Keith T. Flaherty, Michael J. Kaplan, Suzanne L. Topalian, Ashley F. Ward and Marc S. Hurlbert
Kristen L. Mueller
1Melanoma Research Alliance, Washington, DC.
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Marc R. Theoret
2U.S. Food and Drug Administration, Silver Spring, Maryland.
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Steven J. Lemery
2U.S. Food and Drug Administration, Silver Spring, Maryland.
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Laleh Amiri-Kordestani
2U.S. Food and Drug Administration, Silver Spring, Maryland.
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Charlotte E. Ariyan
3Memorial Sloan Kettering Cancer Center, New York, New York.
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Michael B. Atkins
4Georgetown-Lombardi Comprehensive Cancer Center, Washington, DC.
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Donald A. Berry
5University of Texas MD Anderson Cancer Center, Houston, Texas.
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Christian U. Blank
6Netherlands Cancer Institute, Amsterdam, the Netherlands.
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Angela M. DeMichele
7University of Pennsylvania, Philadelphia, Pennsylvania.
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Patrick M. Forde
8Johns Hopkins Bloomberg-Kimmel Institute for Cancer Immunotherapy and Kimmel Cancer Center, Baltimore, Maryland.
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Nageatte Ibrahim
9Merck, Inc., Kenilworth, New Jersey.
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Patricia Keegan
2U.S. Food and Drug Administration, Silver Spring, Maryland.
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Tara C. Mitchell
7University of Pennsylvania, Philadelphia, Pennsylvania.
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Rebecca A. Moss
10Bristol Myers Squibb, Lawrenceville, New Jersey.
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Caroline Robert
11Insitut Gustave Roussy and Paris-Saclay University, Villejuif, France.
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Rajeshwari Sridhara
2U.S. Food and Drug Administration, Silver Spring, Maryland.
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Janis M. Taube
8Johns Hopkins Bloomberg-Kimmel Institute for Cancer Immunotherapy and Kimmel Cancer Center, Baltimore, Maryland.
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Michael T. Tetzlaff
5University of Texas MD Anderson Cancer Center, Houston, Texas.
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Jennifer A. Wargo
5University of Texas MD Anderson Cancer Center, Houston, Texas.
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Keith T. Flaherty
12Massachusetts General Hospital, Boston, Massachusetts.
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Michael J. Kaplan
1Melanoma Research Alliance, Washington, DC.
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Suzanne L. Topalian
8Johns Hopkins Bloomberg-Kimmel Institute for Cancer Immunotherapy and Kimmel Cancer Center, Baltimore, Maryland.
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Ashley F. Ward
2U.S. Food and Drug Administration, Silver Spring, Maryland.
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Marc S. Hurlbert
1Melanoma Research Alliance, Washington, DC.
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  • For correspondence: mhurlbert@curemelanoma.org
DOI: 10.1158/1078-0432.CCR-20-3285 Published January 2021
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ARTICLE USAGE: November 2020 to January 2021

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Article Information

Volume 27, Issue 2, pp. 394-401

DOI 
https://doi.org/10.1158/1078-0432.CCR-20-3285
PubMed 
33188142

Published By 
American Association for Cancer Research
Print ISSN 
1078-0432
Online ISSN 
1557-3265
History 
  • Received August 19, 2020
  • Revision received October 8, 2020
  • Accepted November 10, 2020
  • Published first November 13, 2020.

Article Versions

  • Previous version (November 13, 2020 - 06:18).
  • Previous version (December 30, 2020 - 06:10).
  • You are viewing the most recent version of this article.
Copyright & Usage 
©2020 American Association for Cancer Research.

Author Information

  1. Kristen L. Mueller1,
  2. Marc R. Theoret2,
  3. Steven J. Lemery2,
  4. Laleh Amiri-Kordestani2,
  5. Charlotte E. Ariyan3,
  6. Michael B. Atkins4,
  7. Donald A. Berry5,
  8. Christian U. Blank6,
  9. Angela M. DeMichele7,
  10. Patrick M. Forde8,
  11. Nageatte Ibrahim9,
  12. Patricia Keegan2,
  13. Tara C. Mitchell7,
  14. Rebecca A. Moss10,
  15. Caroline Robert11,
  16. Rajeshwari Sridhara2,
  17. Janis M. Taube8,
  18. Michael T. Tetzlaff5,
  19. Jennifer A. Wargo5,
  20. Keith T. Flaherty12,
  21. Michael J. Kaplan1,
  22. Suzanne L. Topalian8,
  23. Ashley F. Ward2, and
  24. Marc S. Hurlbert1,*
  1. 1Melanoma Research Alliance, Washington, DC.
  2. 2U.S. Food and Drug Administration, Silver Spring, Maryland.
  3. 3Memorial Sloan Kettering Cancer Center, New York, New York.
  4. 4Georgetown-Lombardi Comprehensive Cancer Center, Washington, DC.
  5. 5University of Texas MD Anderson Cancer Center, Houston, Texas.
  6. 6Netherlands Cancer Institute, Amsterdam, the Netherlands.
  7. 7University of Pennsylvania, Philadelphia, Pennsylvania.
  8. 8Johns Hopkins Bloomberg-Kimmel Institute for Cancer Immunotherapy and Kimmel Cancer Center, Baltimore, Maryland.
  9. 9Merck, Inc., Kenilworth, New Jersey.
  10. 10Bristol Myers Squibb, Lawrenceville, New Jersey.
  11. 11Insitut Gustave Roussy and Paris-Saclay University, Villejuif, France.
  12. 12Massachusetts General Hospital, Boston, Massachusetts.
  1. ↵*Corresponding Author:
    Marc S. Hurlbert, Melanoma Research Alliance, 730 15th Street NW, 4th Floor, Washington, DC 20005. Phone: 202-336-7230; E-mail: mhurlbert{at}curemelanoma.org
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Clinical Cancer Research: 27 (2)
January 2021
Volume 27, Issue 2
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Neoadjuvant Therapy for Melanoma: A U.S. Food and Drug Administration—Melanoma Research Alliance Public Workshop
Kristen L. Mueller, Marc R. Theoret, Steven J. Lemery, Laleh Amiri-Kordestani, Charlotte E. Ariyan, Michael B. Atkins, Donald A. Berry, Christian U. Blank, Angela M. DeMichele, Patrick M. Forde, Nageatte Ibrahim, Patricia Keegan, Tara C. Mitchell, Rebecca A. Moss, Caroline Robert, Rajeshwari Sridhara, Janis M. Taube, Michael T. Tetzlaff, Jennifer A. Wargo, Keith T. Flaherty, Michael J. Kaplan, Suzanne L. Topalian, Ashley F. Ward and Marc S. Hurlbert
Clin Cancer Res January 15 2021 (27) (2) 394-401; DOI: 10.1158/1078-0432.CCR-20-3285

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Neoadjuvant Therapy for Melanoma: A U.S. Food and Drug Administration—Melanoma Research Alliance Public Workshop
Kristen L. Mueller, Marc R. Theoret, Steven J. Lemery, Laleh Amiri-Kordestani, Charlotte E. Ariyan, Michael B. Atkins, Donald A. Berry, Christian U. Blank, Angela M. DeMichele, Patrick M. Forde, Nageatte Ibrahim, Patricia Keegan, Tara C. Mitchell, Rebecca A. Moss, Caroline Robert, Rajeshwari Sridhara, Janis M. Taube, Michael T. Tetzlaff, Jennifer A. Wargo, Keith T. Flaherty, Michael J. Kaplan, Suzanne L. Topalian, Ashley F. Ward and Marc S. Hurlbert
Clin Cancer Res January 15 2021 (27) (2) 394-401; DOI: 10.1158/1078-0432.CCR-20-3285
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  • Article
    • Abstract
    • Introduction
    • Lessons Learned from Neoadjuvant Therapies in Other Cancers
    • Neoadjuvant Melanoma Trials
    • Integration of Systemic Neoadjuvant Therapy with Surgery
    • Neoadjuvant Clinical Trial Design and Regulatory Considerations
    • Challenges and Future Research Directions in Neoadjuvant Treatment for Melanoma
    • Conclusions
    • Authors’ Disclosures
    • Disclaimer
    • Acknowledgments
    • Footnotes
    • References
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