Matches in SemOpenAlex for { <https://semopenalex.org/work/W2794310546> ?p ?o ?g. }
Showing items 1 to 88 of
88
with 100 items per page.
- W2794310546 abstract "TPS543 Background: Immunologically, radiation increases tumor antigen release, cytotoxic CD8+ T cell infiltration while reducing myeloid derived suppressor cells (MDSCs), with distant abscopal responses occasionally reported. Radium-223 is a systemically administered bone-targeted alpha emitter that causes double-stranded DNA breaks and may induce similar immune effects. Anti-PD(L1) immune checkpoint inhibitor monotherapy with Atezolizumab demonstrates objective responses in metastatic urothelial cancer. In mouse models, radiotherapy and checkpoint immune inhibitor in combination synergistically reduce tumor growth. We hypothesized that the combination of Atezolizumab and Radium-223 in metastatic urothelial cancer pts with bone metastases would target bone metastases more effectively and yield higher response rates. Methods: Eligibility criteria for this single-site, phase 2 trial of Radium-223 in combination with Atezolizumab include diagnosis of advanced urothelial carcinoma with ≥1 bone metastasis, RECIST 1.1 measurable disease, progression of disease after/on platinum-containing chemotherapy in the metastatic or perioperative setting, ECOG PS of 0-2 and adequate organ function. Twenty-two pts will be treated with Radium-223 at a dose of 55 kBq/kg IV and Atezolizumab 1200mg IV both on day 1 of 21 day cycles. Up to 6 doses of Radium-223 will be administered. Atezolizumab will be continued until lack of clinical benefit or intolerable toxicity for up to 17 cycles. Routine response assessment will be performed every 12 weeks. Primary endpoint is best overall response per RECIST 1.1. Secondary objectives are to determine the safety and tolerability; determine the overall survival, progression free survival, clinical benefit rate, complete response rate and duration of response; and changes in quality of life as assessed by the EORTC QLQ-C30 score. Exploratory objectives are PD-L1 status by IHC, changes in bone scan per EXINI bone scan index and efficacy measures by irRC. If ≥6 pts respond, corresponding to an ORR of 27% with 80% confidence limits of 15%-43%, further study of the combination would be warranted. Blood and archival tissue will be collected for correlative studies. Clinical trial information: NCT03208712." @default.
- W2794310546 created "2018-03-29" @default.
- W2794310546 creator A5019390129 @default.
- W2794310546 creator A5021290731 @default.
- W2794310546 creator A5033671689 @default.
- W2794310546 creator A5044876102 @default.
- W2794310546 creator A5059648298 @default.
- W2794310546 date "2018-02-20" @default.
- W2794310546 modified "2023-09-27" @default.
- W2794310546 title "Radium-223 and atezolizumab in platinum refractory urothelial carcinoma with bone metastases: NCT03208712." @default.
- W2794310546 doi "https://doi.org/10.1200/jco.2018.36.6_suppl.tps543" @default.
- W2794310546 hasPublicationYear "2018" @default.
- W2794310546 type Work @default.
- W2794310546 sameAs 2794310546 @default.
- W2794310546 citedByCount "0" @default.
- W2794310546 crossrefType "journal-article" @default.
- W2794310546 hasAuthorship W2794310546A5019390129 @default.
- W2794310546 hasAuthorship W2794310546A5021290731 @default.
- W2794310546 hasAuthorship W2794310546A5033671689 @default.
- W2794310546 hasAuthorship W2794310546A5044876102 @default.
- W2794310546 hasAuthorship W2794310546A5059648298 @default.
- W2794310546 hasConcept C121608353 @default.
- W2794310546 hasConcept C126322002 @default.
- W2794310546 hasConcept C143998085 @default.
- W2794310546 hasConcept C203014093 @default.
- W2794310546 hasConcept C2775949291 @default.
- W2794310546 hasConcept C2777472916 @default.
- W2794310546 hasConcept C2777701055 @default.
- W2794310546 hasConcept C2777783956 @default.
- W2794310546 hasConcept C2779013556 @default.
- W2794310546 hasConcept C2780057760 @default.
- W2794310546 hasConcept C2780352672 @default.
- W2794310546 hasConcept C2780851360 @default.
- W2794310546 hasConcept C2781064419 @default.
- W2794310546 hasConcept C2781274730 @default.
- W2794310546 hasConcept C2911057145 @default.
- W2794310546 hasConcept C3019882237 @default.
- W2794310546 hasConcept C502942594 @default.
- W2794310546 hasConcept C509974204 @default.
- W2794310546 hasConcept C71924100 @default.
- W2794310546 hasConcept C8891405 @default.
- W2794310546 hasConceptScore W2794310546C121608353 @default.
- W2794310546 hasConceptScore W2794310546C126322002 @default.
- W2794310546 hasConceptScore W2794310546C143998085 @default.
- W2794310546 hasConceptScore W2794310546C203014093 @default.
- W2794310546 hasConceptScore W2794310546C2775949291 @default.
- W2794310546 hasConceptScore W2794310546C2777472916 @default.
- W2794310546 hasConceptScore W2794310546C2777701055 @default.
- W2794310546 hasConceptScore W2794310546C2777783956 @default.
- W2794310546 hasConceptScore W2794310546C2779013556 @default.
- W2794310546 hasConceptScore W2794310546C2780057760 @default.
- W2794310546 hasConceptScore W2794310546C2780352672 @default.
- W2794310546 hasConceptScore W2794310546C2780851360 @default.
- W2794310546 hasConceptScore W2794310546C2781064419 @default.
- W2794310546 hasConceptScore W2794310546C2781274730 @default.
- W2794310546 hasConceptScore W2794310546C2911057145 @default.
- W2794310546 hasConceptScore W2794310546C3019882237 @default.
- W2794310546 hasConceptScore W2794310546C502942594 @default.
- W2794310546 hasConceptScore W2794310546C509974204 @default.
- W2794310546 hasConceptScore W2794310546C71924100 @default.
- W2794310546 hasConceptScore W2794310546C8891405 @default.
- W2794310546 hasLocation W27943105461 @default.
- W2794310546 hasOpenAccess W2794310546 @default.
- W2794310546 hasPrimaryLocation W27943105461 @default.
- W2794310546 hasRelatedWork W120196646 @default.
- W2794310546 hasRelatedWork W2083304288 @default.
- W2794310546 hasRelatedWork W2105137065 @default.
- W2794310546 hasRelatedWork W2150293352 @default.
- W2794310546 hasRelatedWork W2553051584 @default.
- W2794310546 hasRelatedWork W2797220830 @default.
- W2794310546 hasRelatedWork W2803095718 @default.
- W2794310546 hasRelatedWork W2809064179 @default.
- W2794310546 hasRelatedWork W2809636777 @default.
- W2794310546 hasRelatedWork W2810071575 @default.
- W2794310546 hasRelatedWork W287605918 @default.
- W2794310546 hasRelatedWork W2887380334 @default.
- W2794310546 hasRelatedWork W2896289964 @default.
- W2794310546 hasRelatedWork W2968883157 @default.
- W2794310546 hasRelatedWork W2972875473 @default.
- W2794310546 hasRelatedWork W3009567378 @default.
- W2794310546 hasRelatedWork W3049730235 @default.
- W2794310546 hasRelatedWork W3093978045 @default.
- W2794310546 hasRelatedWork W3109469413 @default.
- W2794310546 hasRelatedWork W3116949849 @default.
- W2794310546 isParatext "false" @default.
- W2794310546 isRetracted "false" @default.
- W2794310546 magId "2794310546" @default.
- W2794310546 workType "article" @default.