{"database":"biostudies-literature","file_versions":[],"scores":null,"additional":{"submitter":["Sanborn RE"],"funding":["NCATS NIH HHS","NIH/NCI Cancer Center Support Grant","Bristol Myers Squibb","Celldex Therapeutics, Inc.","NCI NIH HHS"],"pagination":["e005147"],"full_dataset_link":["https://www.ebi.ac.uk/biostudies/studies/S-EPMC9364417"],"repository":["biostudies-literature"],"omics_type":["Unknown"],"volume":["10(8)"],"pubmed_abstract":["<h4>Background</h4>Phase 1/2 dose-escalation and expansion study evaluating varlilumab, a fully human agonist anti-CD27 mAb, with nivolumab in anti-PD-1/L1 naïve, refractory solid tumors.<h4>Methods</h4>Phase 1 evaluated the safety of varlilumab (0.1-10 mg/kg) with nivolumab (3 mg/kg) administered once every 2 weeks. Phase 2 evaluated varlilumab regimens (3 mg/kg once every 2 weeks, 3 mg/kg once every 12 weeks, and 0.3 mg/kg once every 4 weeks) with nivolumab 240 mg once every 2 weeks in tumor-specific cohorts. Primary objective was safety; key clinical endpoints included objective response rate (ORR) and overall survival rate at 12 months (OS12) (glioblastoma (GBM) only). Exploratory objectives included determination of effects on peripheral blood and intratumoral immune signatures.<h4>Re"],"journal":["Journal for immunotherapy of cancer"],"pubmed_title":["Safety, tolerability and efficacy of agonist anti-CD27 antibody (varlilumab) administered in combination with anti-PD-1 (nivolumab) in advanced solid tumors."],"pmcid":["PMC9364417"],"funding_grant_id":["P30 CA008748","UL1 TR001863"],"pubmed_authors":["Sikic BI","Kaley T","Baehring JM","Hawthorne TR","Callahan MK","Sznol M","Rawls T","Iwamoto F","Lutzky J","Subramaniam DS","Aragon-Ching JB","Rahma O","Sanborn RE","Bauman JE","Reardon DA","Rizvi NA","Jimeno A","Yellin M","Cho DC","Pishvaian MJ","Bitting RL","Starodub A","Weise A","Keler T"],"additional_accession":[]},"is_claimable":false,"name":"Safety, tolerability and efficacy of agonist anti-CD27 antibody (varlilumab) administered in combination with anti-PD-1 (nivolumab) in advanced solid tumors.","description":"<h4>Background</h4>Phase 1/2 dose-escalation and expansion study evaluating varlilumab, a fully human agonist anti-CD27 mAb, with nivolumab in anti-PD-1/L1 naïve, refractory solid tumors.<h4>Methods</h4>Phase 1 evaluated the safety of varlilumab (0.1-10 mg/kg) with nivolumab (3 mg/kg) administered once every 2 weeks. Phase 2 evaluated varlilumab regimens (3 mg/kg once every 2 weeks, 3 mg/kg once every 12 weeks, and 0.3 mg/kg once every 4 weeks) with nivolumab 240 mg once every 2 weeks in tumor-specific cohorts. Primary objective was safety; key clinical endpoints included objective response rate (ORR) and overall survival rate at 12 months (OS12) (glioblastoma (GBM) only). Exploratory objectives included determination of effects on peripheral blood and intratumoral immune signatures.<h4>Re","dates":{"release":"2022-01-01T00:00:00Z","publication":"2022 Aug","modification":"2026-06-15T06:15:38.272Z","creation":"2026-06-15T03:08:33.065Z"},"accession":"S-EPMC9364417","cross_references":{"pubmed":["35940825"],"doi":["10.1136/jitc-2022-005147"]}}