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Table 4 Association of clinical activity with tumor biomarkers.

From: A prospective phase II trial exploring the association between tumor microenvironment biomarkers and clinical activity of ipilimumab in advanced melanoma

Biomarker Observed Effect P- value*
  Benefit Group
(n = 21)
Non-benefit Group
(n = 43)
TILs change from baseline to week 4, by H&E 4/7 increase
0/7 decrease
3/7 no change
2/20 increase
3/20 decrease
15/20 no change
FoxP3 expression at baseline, by IHC 6/8 evaluable patients positive 9/25 evaluable patients positive 0.014
IDO expression at baseline, by IHC 3/8 evaluable patients positive 3/27 evaluable patients positive 0.012
  1. *P-values are for tests of association between biomarker and clinical activity and are uncorrected for multiple testing.
  2. H&E: hematoxylin and eosin; IDO: indoleamine 2,3-dioxygenase; IHC: immunohistochemistry; TILs: tumor-infiltrating lymphocytes.