{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,8,8]],"date-time":"2026-08-08T02:44:08Z","timestamp":1786157048041,"version":"build-2736575974"},"reference-count":53,"publisher":"Oxford University Press (OUP)","issue":"9","license":[{"start":{"date-parts":[[2026,7,30]],"date-time":"2026-07-30T00:00:00Z","timestamp":1785369600000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0\/"}],"funder":[{"name":"Incyte Corporation, Wilmington, DE, USA"}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":[],"published-print":{"date-parts":[[2026,8,6]]},"abstract":"<jats:title>Abstract<\/jats:title>\n                  <jats:sec>\n                    <jats:title>Background<\/jats:title>\n                    <jats:p>Modulating tumor-mediated immunosuppression with immunotherapies is an effective therapeutic approach for solid tumors. INCAGN01876 is a humanized IgG1 anti-glucocorticoid-induced tumor necrosis factor receptor (GITR) monoclonal antibody. This phase 1\/2 trial evaluated INCAGN01876 plus nivolumab and\/or ipilimumab for advanced malignancies.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Methods<\/jats:title>\n                    <jats:p>In phase 1 (dose escalation), patients received various INCAGN01876 plus nivolumab and\/or ipilimumab regimens. In phase 2 (dose expansion), patients with select tumors received INCAGN01876 plus ipilimumab (treatment group [TG] C2) or INCAGN01876 plus nivolumab (TGF). Primary endpoints: safety (phase 1), objective response rate (ORR; phase 2).<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Results<\/jats:title>\n                    <jats:p>Overall, 145 patients were enrolled: 51 and 94 in phases 1 and 2, respectively (TGC2, n\u2009=\u20098; TGF, n\u2009=\u200986 [squamous cell carcinoma of the head and neck, SCCHN, n\u2009=\u200946]). Four patients had dose-limiting toxicities; maximum tolerated dose was not reached; INCAGN01876 300\u2009mg Q2W was selected as the recommended phase 2 dose based on safety with nivolumab and\/or ipilimumab and safety and pharmacokinetic\/pharmacodynamic monotherapy data from the INCAGN 1876-101 phase 1 study. INCAGN01876-related treatment-emergent adverse events (TEAEs) occurred in 62.8% of patients (most commonly pruritus, 16.6%); grade \u22653, 13.8%. Immune-related TEAEs occurred in 31.0% of patients (most frequently pruritus, 11.7%) most were (75.6%) grade 1\/2 events. Antitumor activity was observed in TGF cohorts with SCCHN or cervical cancer (ORR 23.9% and 16.7%, respectively).<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Conclusion<\/jats:title>\n                    <jats:p>INCAGN01876 plus nivolumab and\/or ipilimumab was generally well tolerated, with a safety profile consistent with previous reports. This observation, along with encouraging antitumor activity in SCCHN and cervical cancer, supports development of INCAGN01876 combined with immune checkpoint inhibitors.<\/jats:p>\n                  <\/jats:sec>","DOI":"10.1093\/oncolo\/oyag257","type":"journal-article","created":{"date-parts":[[2026,7,30]],"date-time":"2026-07-30T11:54:35Z","timestamp":1785412475000},"source":"Crossref","is-referenced-by-count":0,"title":["Phase 1\/2 study of INCAGN01876, an anti-glucocorticoid-induced tumor necrosis factor receptor\u00a0agonist monoclonal antibody, plus immunotherapy for advanced cancers"],"prefix":"10.1093","volume":"31","author":[{"ORCID":"https:\/\/orcid.org\/0000-0002-8238-4655","authenticated-orcid":false,"given":"Omid","family":"Hamid","sequence":"first","affiliation":[{"name":"The Angeles Clinic and Research Institute, A Cedars Sinai Affiliate , Los Angeles, CA, 90025,","place":["United 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