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Clinical Trials: Immunotherapy

Ipilimumab and Radiation in Patients with High-risk Resected or Regionally Advanced Melanoma

April K.S. Salama, Manisha Palta, Christel N. Rushing, M. Angelica Selim, Kristen N. Linney, Brian G. Czito, David S. Yoo, Brent A. Hanks, Georgia M. Beasley, Paul J. Mosca, Chelsae Dumbauld, Katelyn N. Steadman, John S. Yi, Kent J. Weinhold, Douglas S. Tyler, Walter T. Lee and David M. Brizel
April K.S. Salama
1Department of Medicine, Division of Medical Oncology, Duke University, Durham, North Carolina.
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  • For correspondence: april.salama@duke.edu
Manisha Palta
2Department of Radiation Oncology, Duke University, Durham, North Carolina.
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Christel N. Rushing
3Biostatistics, Duke Cancer Institute, Durham, North Carolina.
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M. Angelica Selim
4Department of Pathology, Duke University, Durham, North Carolina.
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Kristen N. Linney
5Duke Clinical Research Institute, Durham, North Carolina.
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Brian G. Czito
2Department of Radiation Oncology, Duke University, Durham, North Carolina.
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David S. Yoo
2Department of Radiation Oncology, Duke University, Durham, North Carolina.
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Brent A. Hanks
1Department of Medicine, Division of Medical Oncology, Duke University, Durham, North Carolina.
6Department of Pharmacology and Cancer Biology, Durham, North Carolina.
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Georgia M. Beasley
7Department of Surgery, Duke University, Durham, North Carolina.
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Paul J. Mosca
7Department of Surgery, Duke University, Durham, North Carolina.
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Chelsae Dumbauld
8Department of Immunology, Mayo Clinic Scottsdale, Scottsdale, Arizona.
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Katelyn N. Steadman
7Department of Surgery, Duke University, Durham, North Carolina.
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John S. Yi
7Department of Surgery, Duke University, Durham, North Carolina.
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Kent J. Weinhold
7Department of Surgery, Duke University, Durham, North Carolina.
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Douglas S. Tyler
9Department of Surgery, The University of Texas Medical Branch at Galveston, Galveston, Texas.
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Walter T. Lee
10Department of Head and Neck Surgery & Communication Sciences, Duke University, Durham, North Carolina.
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David M. Brizel
2Department of Radiation Oncology, Duke University, Durham, North Carolina.
10Department of Head and Neck Surgery & Communication Sciences, Duke University, Durham, North Carolina.
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DOI: 10.1158/1078-0432.CCR-20-2452 Published March 2021
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Abstract

Purpose: In this prospective trial, we sought to assess the feasibility of concurrent administration of ipilimumab and radiation as adjuvant, neoadjuvant, or definitive therapy in patients with regionally advanced melanoma.

Patients and Methods: Twenty-four patients in two cohorts were enrolled and received ipilimumab at 3 mg/kg every 3 weeks for four doses in conjunction with radiation; median dose was 4,000 cGy (interquartile range, 3,550–4,800 cGy). Patients in cohort 1 were treated adjuvantly; patients in cohort 2 were treated either neoadjuvantly or as definitive therapy.

Results: Adverse event profiles were consistent with those previously reported with checkpoint inhibition and radiation. For the neoadjuvant/definitive cohort, the objective response rate was 64% (80% confidence interval, 40%–83%), with 4 of 10 evaluable patients achieving a radiographic complete response. An additional 3 patients in this cohort had a partial response and went on to surgical resection. With 2 years of follow-up, the 6-, 12-, and 24-month relapse-free survival for the adjuvant cohort was 85%, 69%, and 62%, respectively. At 2 years, all patients in the neoadjuvant/definitive cohort and 10/13 patients in the adjuvant cohort were still alive. Correlative studies suggested that response in some patients were associated with specific CD4+ T-cell subsets.

Conclusions: Overall, concurrent administration of ipilimumab and radiation was feasible, and resulted in a high response rate, converting some patients with unresectable disease into surgical candidates. Additional studies to investigate the combination of radiation and checkpoint inhibitor therapy are warranted.

Footnotes

  • Note: Supplementary data for this article are available at Clinical Cancer Research Online (http://clincancerres.aacrjournals.org/).

  • Clin Cancer Res 2021;27:1287–95

  • Received June 25, 2020.
  • Revision received September 22, 2020.
  • Accepted November 5, 2020.
  • Published first November 10, 2020.
  • ©2020 American Association for Cancer Research.
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Clinical Cancer Research: 27 (5)
March 2021
Volume 27, Issue 5
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Ipilimumab and Radiation in Patients with High-risk Resected or Regionally Advanced Melanoma
April K.S. Salama, Manisha Palta, Christel N. Rushing, M. Angelica Selim, Kristen N. Linney, Brian G. Czito, David S. Yoo, Brent A. Hanks, Georgia M. Beasley, Paul J. Mosca, Chelsae Dumbauld, Katelyn N. Steadman, John S. Yi, Kent J. Weinhold, Douglas S. Tyler, Walter T. Lee and David M. Brizel
Clin Cancer Res March 1 2021 (27) (5) 1287-1295; DOI: 10.1158/1078-0432.CCR-20-2452

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Ipilimumab and Radiation in Patients with High-risk Resected or Regionally Advanced Melanoma
April K.S. Salama, Manisha Palta, Christel N. Rushing, M. Angelica Selim, Kristen N. Linney, Brian G. Czito, David S. Yoo, Brent A. Hanks, Georgia M. Beasley, Paul J. Mosca, Chelsae Dumbauld, Katelyn N. Steadman, John S. Yi, Kent J. Weinhold, Douglas S. Tyler, Walter T. Lee and David M. Brizel
Clin Cancer Res March 1 2021 (27) (5) 1287-1295; DOI: 10.1158/1078-0432.CCR-20-2452
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