biostudies-literatureYap TANCATS NIH HHSNCI NIH HHSCancer Prevention Research Institute of TexasClinical Translational Science AwardNIH NCI3695-3708https://www.ebi.ac.uk/biostudies/studies/S-EPMC9433959biostudies-literatureUnknown28(17)<h4>Purpose</h4>The first-in-human phase I/II ICONIC trial evaluated an investigational inducible costimulator (ICOS) agonist, vopratelimab, alone and in combination with nivolumab in patients with advanced solid tumors.<h4>Patients and methods</h4>In phase I, patients were treated with escalating doses of intravenous vopratelimab alone or with nivolumab. Primary objectives were safety, tolerability, MTD, and recommended phase II dose (RP2D). Phase II enriched for ICOS-positive (ICOS+) tumors; patients were treated with vopratelimab at the monotherapy RP2D alone or with nivolumab. Pharmacokinetics, pharmacodynamics, and predictive biomarkers of response to vopratelimab were assessed.<h4>Results</h4>ICONIC enrolled 201 patients. Vopratelimab alone and with nivolumab was well tolerated; phasClinical cancer research : an official journal of the American Association for Cancer ResearchFirst-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.PMC9433959P30 CA016672P30 CA008748UL1 TR003167R01 CA255074RP150535UL1 TR0018631UL1 TR003167Murray RBurris HARahma OETykodi SSBlum Murphy MPapadopoulos KPHanson AKummar SFelitsky DHart CGainor JFLoRusso PPark HCallahan MKHashambhoy-Ramsay YBaeck JXiao XFan MYap TAHarvey CJTrehu EMcComb RZhang WJimenez JLaken HHooper EBrown KFalchook GSSepahi AMcGrath LCohen HSeiwert TYPachynski RKGibney GTfalseFirst-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.<h4>Purpose</h4>The first-in-human phase I/II ICONIC trial evaluated an investigational inducible costimulator (ICOS) agonist, vopratelimab, alone and in combination with nivolumab in patients with advanced solid tumors.<h4>Patients and methods</h4>In phase I, patients were treated with escalating doses of intravenous vopratelimab alone or with nivolumab. Primary objectives were safety, tolerability, MTD, and recommended phase II dose (RP2D). Phase II enriched for ICOS-positive (ICOS+) tumors; patients were treated with vopratelimab at the monotherapy RP2D alone or with nivolumab. Pharmacokinetics, pharmacodynamics, and predictive biomarkers of response to vopratelimab were assessed.<h4>Results</h4>ICONIC enrolled 201 patients. Vopratelimab alone and with nivolumab was well tolerated; phas2022-01-01T00:00:00Z2022 Sep2026-05-10T06:33:19.346Z2024-11-12T09:51:11.313ZS-EPMC94339593551193810.1158/1078-0432.CCR-21-4256