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First-in-Human Phase I/II ICONIC Trial of the ICOS Agonist Vopratelimab Alone and with Nivolumab: ICOS-High CD4 T-Cell Populations and Predictors of Response.

Timothy Anthony YapJustin F GainorMargaret K CallahanGerald S FalchookRussell K PachynskiPatricia LoRussoShivaani KummarGeoffrey T GibneyHoward A BurrisScott S TykodiOsama E RahmaTanguy Y SeiwertKyriakos P PapadopoulosMariela Blum MurphyHaeseong ParkAmanda HansonYasmin Hashambhoy-RamsayLara McGrathEllen HooperXiaoying XiaoHeather CohenMartin FanDaniel FelitskyCourtney HartRachel McCombKaren BrownAli SepahiJudith JimenezWeidong ZhangJohan BaeckHaley LakenRichard MurrayElizabeth TrehuChristopher J Harvey
Published in: Clinical cancer research : an official journal of the American Association for Cancer Research (2022)
Vopratelimab demonstrated a favorable safety profile alone and in combination with nivolumab. Efficacy was observed only in a subset of patients with a vopratelimab-specific pharmacodynamic biomarker. A potential predictive biomarker of response was identified, which is being prospectively evaluated in a randomized phase II non-small cell lung cancer trial. See related commentary by Lee and Fong, p. 3633.
Keyphrases
  • phase ii
  • clinical trial
  • open label
  • phase iii
  • endothelial cells
  • study protocol
  • double blind
  • randomized controlled trial
  • induced pluripotent stem cells
  • risk assessment
  • human health