Neoadjuvant Combination Biotherapy With Ipilimumab and Nivolumab or Nivolumab Alone
Status:
Withdrawn
Trial end date:
2017-02-09
Target enrollment:
Participant gender:
Summary
This study plans to test the pathologic complete response (pCR) rate of the combination
biotherapy regimen consisting of nivolumab plus ipilimumab versus nivolumab alone in patients
with advanced but operable melanoma. Evaluation of the presence of tumor-infiltrating CD8+ T
cells as well as that of PDL1 expression and IDO expression will be associated with clinical
response (pathologic and/or radiologic). The study will test the radiologic/clinical
preoperative response rate, recurrence free survival (RFS) and overall survival (OS). It will
evaluate the safety of neoadjuvant nivolumab and neoadjuvant nivolumab-ipilimumab. Up to 66
patients will be randomized in 1:1 ratio.