FRINK Linked Data Fragments server

Matches in SemOpenAlex for { <https://semopenalex.org/work/W4324136507> ?p ?o ?g. }

• W4324136507 endingPage "TPS598" @default.
• W4324136507 startingPage "TPS598" @default.
• W4324136507 abstract "TPS598 Background: SG is an antibody-drug conjugate composed of an anti-trophoblast cell-surface antigen-2 (Trop-2) antibody coupled to a topoisomerase-I inhibitor, SN-38, via a hydrolyzable linker. In Cohort 1 of the phase 2 TROPHY-U-01 trial, SG monotherapy resulted in a 27% objective response rate (ORR) and median overall survival (OS) of 10.9 months with an overall manageable toxicity profile in pts with locally advanced or mUC who previously received platinum-based therapy and a checkpoint inhibitor (CPI; Tagawa S, et al. J Clin Oncol. 2021). These results led to accelerated FDA approval of SG in this population. The CPI ZIM is a fully human IgG4 monoclonal antibody targeting PD-1. CPIs are active in mUC, including avelumab that is FDA-approved as switch maintenance therapy for locally advanced or mUC that has not progressed with first-line platinum-based chemotherapy. Cohort 5 of the TROPHY-U-01 trial will evaluate the safety, tolerability, and efficacy of SG + ZIM vs ZIM alone vs avelumab as switch maintenance in pts with mUC who have received gemcitabine (GEM)/cisplatin without progressive disease (PD). Methods: TROPHY-U-01 (NCT03547973) is a multicohort, open-label, global, phase 2 trial. Cohort 5 includes pts who have not progressed after completion of 4-6 cycles of GEM/cisplatin. Key eligibility requirements include ≥18 y; ECOG PS 0-1; available tissue for biomarker testing; adequate blood counts without transfusion or growth factor within 2 weeks of study drug initiation; creatinine clearance ≥30 mL/min. A safety lead-in of 6-8 pts will be conducted, where pts will be treated with SG 10 mg/kg IV on D1 and D8 of a 21-D cycle plus ZIM 360 mg IV q3wk on a 21-D cycle. On safety lead-in, if SG + ZIM is deemed safe, pts will be randomized 1:1:1. Those in Arm 1 will receive SG 10 mg/kg IV on D1 and D8 of a 21-D cycle followed by ZIM 360 mg IV, q3wk (D1 of a 21-D cycle). Pts in Arm 2 will receive avelumab 800 mg IV q2wk (D1 of a 14-D cycle). Pts in Arm 3 will receive ZIM 360 mg IV q3wk. All pts will continue treatment until PD, unacceptable toxicity, or loss of clinical benefit. The primary endpoint is progression-free survival based on central review by RECIST 1.1 criteria. Secondary endpoints include OS (all arms), safety/tolerability of SG in combination with ZIM (Arm 1). Cohort 5 aims to enroll an estimated 158 pts. A sample size of 50 pts per randomized arm is determined based on clinical consideration for exploring the activity of anticancer agents. Clinical trial information: NCT03547973 ." @default.
• W4324136507 created "2023-03-15" @default.
• W4324136507 creator A5018235125 @default.
• W4324136507 creator A5023476852 @default.
• W4324136507 creator A5026717218 @default.
• W4324136507 creator A5027991868 @default.
• W4324136507 creator A5030902321 @default.
• W4324136507 creator A5036620887 @default.
• W4324136507 creator A5051003180 @default.
• W4324136507 creator A5062347312 @default.
• W4324136507 creator A5072911394 @default.
• W4324136507 creator A5073032898 @default.
• W4324136507 creator A5073289880 @default.
• W4324136507 creator A5083331837 @default.
• W4324136507 date "2023-02-20" @default.
• W4324136507 modified "2023-10-18" @default.
• W4324136507 title "TROPHU-U-01 cohort 5: Evaluation of maintenance sacituzumab govitecan (SG) plus zimberelimab (ZIM), ZIM, or avelumab in cisplatin-eligible patients (pts) with unresectable or metastatic urothelial cancer (mUC)." @default.
• W4324136507 doi "https://doi.org/10.1200/jco.2023.41.6_suppl.tps598" @default.
• W4324136507 hasPublicationYear "2023" @default.
• W4324136507 type Work @default.
• W4324136507 citedByCount "2" @default.
• W4324136507 countsByYear W43241365072023 @default.
• W4324136507 crossrefType "journal-article" @default.
• W4324136507 hasAuthorship W4324136507A5018235125 @default.
• W4324136507 hasAuthorship W4324136507A5023476852 @default.
• W4324136507 hasAuthorship W4324136507A5026717218 @default.
• W4324136507 hasAuthorship W4324136507A5027991868 @default.
• W4324136507 hasAuthorship W4324136507A5030902321 @default.
• W4324136507 hasAuthorship W4324136507A5036620887 @default.
• W4324136507 hasAuthorship W4324136507A5051003180 @default.
• W4324136507 hasAuthorship W4324136507A5062347312 @default.
• W4324136507 hasAuthorship W4324136507A5072911394 @default.
• W4324136507 hasAuthorship W4324136507A5073032898 @default.
• W4324136507 hasAuthorship W4324136507A5073289880 @default.
• W4324136507 hasAuthorship W4324136507A5083331837 @default.
• W4324136507 hasConcept C121608353 @default.
• W4324136507 hasConcept C126322002 @default.
• W4324136507 hasConcept C126894567 @default.
• W4324136507 hasConcept C141071460 @default.
• W4324136507 hasConcept C143998085 @default.
• W4324136507 hasConcept C159654299 @default.
• W4324136507 hasConcept C197934379 @default.
• W4324136507 hasConcept C203014093 @default.
• W4324136507 hasConcept C207103383 @default.
• W4324136507 hasConcept C2776146153 @default.
• W4324136507 hasConcept C2776694085 @default.
• W4324136507 hasConcept C2777381376 @default.
• W4324136507 hasConcept C2777701055 @default.
• W4324136507 hasConcept C2777742743 @default.
• W4324136507 hasConcept C2778239845 @default.
• W4324136507 hasConcept C2778375690 @default.
• W4324136507 hasConcept C2780030458 @default.
• W4324136507 hasConcept C2780258809 @default.
• W4324136507 hasConcept C2908647359 @default.
• W4324136507 hasConcept C44249647 @default.
• W4324136507 hasConcept C542903549 @default.
• W4324136507 hasConcept C71924100 @default.
• W4324136507 hasConcept C72563966 @default.
• W4324136507 hasConcept C99454951 @default.
• W4324136507 hasConceptScore W4324136507C121608353 @default.
• W4324136507 hasConceptScore W4324136507C126322002 @default.
• W4324136507 hasConceptScore W4324136507C126894567 @default.
• W4324136507 hasConceptScore W4324136507C141071460 @default.
• W4324136507 hasConceptScore W4324136507C143998085 @default.
• W4324136507 hasConceptScore W4324136507C159654299 @default.
• W4324136507 hasConceptScore W4324136507C197934379 @default.
• W4324136507 hasConceptScore W4324136507C203014093 @default.
• W4324136507 hasConceptScore W4324136507C207103383 @default.
• W4324136507 hasConceptScore W4324136507C2776146153 @default.
• W4324136507 hasConceptScore W4324136507C2776694085 @default.
• W4324136507 hasConceptScore W4324136507C2777381376 @default.
• W4324136507 hasConceptScore W4324136507C2777701055 @default.
• W4324136507 hasConceptScore W4324136507C2777742743 @default.
• W4324136507 hasConceptScore W4324136507C2778239845 @default.
• W4324136507 hasConceptScore W4324136507C2778375690 @default.
• W4324136507 hasConceptScore W4324136507C2780030458 @default.
• W4324136507 hasConceptScore W4324136507C2780258809 @default.
• W4324136507 hasConceptScore W4324136507C2908647359 @default.
• W4324136507 hasConceptScore W4324136507C44249647 @default.
• W4324136507 hasConceptScore W4324136507C542903549 @default.
• W4324136507 hasConceptScore W4324136507C71924100 @default.
• W4324136507 hasConceptScore W4324136507C72563966 @default.
• W4324136507 hasConceptScore W4324136507C99454951 @default.
• W4324136507 hasIssue "6_suppl" @default.
• W4324136507 hasLocation W43241365071 @default.
• W4324136507 hasOpenAccess W4324136507 @default.
• W4324136507 hasPrimaryLocation W43241365071 @default.
• W4324136507 hasRelatedWork W2742578294 @default.
• W4324136507 hasRelatedWork W2749169318 @default.
• W4324136507 hasRelatedWork W2765949442 @default.
• W4324136507 hasRelatedWork W2884534038 @default.
• W4324136507 hasRelatedWork W2894742494 @default.
• W4324136507 hasRelatedWork W2915069424 @default.
• W4324136507 hasRelatedWork W4226245858 @default.
• W4324136507 hasRelatedWork W4230187632 @default.
• W4324136507 hasRelatedWork W4293000834 @default.
• W4324136507 hasRelatedWork W4221164592 @default.
• W4324136507 hasVolume "41" @default.

• next