FRINK Linked Data Fragments server

Matches in SemOpenAlex for { <https://semopenalex.org/work/W4308384789> ?p ?o ?g. }

• W4308384789 abstract "<h3>Background</h3> CG0070, is an Ad5-based oncolytic vaccine engineered to express GM-CSF and replicate selectively in tumor cells with mutated or deficient RB. The CG0070 mechanism of action includes cell lysis and immunogenic cell death which is enhanced in the presence of GM-CSF. In an open label ph. 2 study, an overall CR rate of 62% and a CR at 12 months (m) of 29% have been observed in patients with high risk NMIBC previously treated with BCG. IV pembrolizumab, was recently approved by the FDA for patients with BCG-unresponsive CIS (with or without papillary tumors) with an overall complete RR of 41% and a 12 m CR rate of ~20%. This ph. 2 study will assess the potential synergy of the two agents in the treatment of BCG-unresponsive NMIBC. <h3>Methods</h3> 35 pts with BCG-unresponsive CIS with or without concurrent Ta or T1 disease will be treated with intravescical CG0070 (1x10¹² vp) in combination with pembrolizumab at a dose of 400 mg IV q6 weeks. CG0070 will be administered weekly x 6 as induction followed by weekly x 3 maintenance instillations at months 3, 6, 9, 12, and 18. Patients with persistent CIS or HG Ta at 3 m may receive re-induction with weekly x 6 of CG0070. Pembrolizumab will be administered up to 24 m. Assessment of response will include q 3 m cystoscopy with biopsy of areas suspicious for disease, urine cytology, CTU/MRU, and mandatory bladder mapping biopsies at 12 m. Recurrence of HG disease will be enumerated as disease recurrence. The primary endpoint of the study is CR at 12 m. Secondary endpoints will include CR at any time, progression free survival, duration of response, cystectomy free survival and the safety. <h3>Results</h3> Enrollment has been completed. Based on follow up thus far, CR rate of 92% (22/24) at 3 m has been observed. All patients in CR at 3 m remain in CR at downstream timepoints including: 14/16 at 6 m, 9/11 at 9 m, and 6/8 at 12 m. Treatment related AE are consistent with those observed in studies of each agent alone. <h3>Conclusions</h3> This initial data on the efficacy and safety of CG0070 plus pembrolizumab for the treatment of BCG unresponsive NMIBC is encouraging. Data on efficacy and safety for all enrolled patients, N=35, as well as biomarker (CAR, E2F, and PDL1) assessment will be presented at the time of the conference. <h3>Trial Registration</h3> NCT04387461 <h3>Ethics Approval</h3> CENTRAL IRB Castle: Protocol Number: CORE-001 (CG2003C) <h3>Sponsor</h3> CG Oncology, Inc <h3>Study Title</h3> A Phase 2, Single Arm Study of CG0070 Combined with Pembrolizumab in Patients with Non- Muscle Invasive Bladder Cancer (NMIBC) Unresponsive to Bacillus Calmette-Guerin (BCG) Study Materials Reviewed and Approved by Castle IRB: • Clinical Study Protocol CORE-001 (CG2003C) Summary of Changes, Version: Amendment 4, 24JAN 2022 • Clinical Study Protocol CORE-001 (CG2003C), Version: Amendment 4, 24 JAN 2022 • Investigator’s Brochure Pembrolizumab Risk Language, Version: Edition 03 SEP 2021 • Investigator’s Brochure Pembrolizumab, Version: Edition 21, 02 SEP 2021 • Master Informed Consent Form Template, Version: 5, 04 FEB 2022 • Patient Educational Slide Deck Sites Approved by Castle IRB as part of this submission: • CORE-001-BCG Oncology (Donald Lamm, MD) • CORE-001-Chesapeake Urology Research Associates (Rian Dickstein, MD) • CORE-001-Genesis Research, LLC 1 (Richard David, MD) • CORE-001-Keystone Urology Specialists (Paul Sieber, MD) • CORE-001-Spokane Urology (Shane Pearce, MD)" @default.
• W4308384789 created "2022-11-11" @default.
• W4308384789 creator A5011089375 @default.
• W4308384789 creator A5019497849 @default.
• W4308384789 creator A5020983805 @default.
• W4308384789 creator A5029026130 @default.
• W4308384789 creator A5029221328 @default.
• W4308384789 creator A5034005227 @default.
• W4308384789 creator A5038887077 @default.
• W4308384789 creator A5052301584 @default.
• W4308384789 creator A5054735116 @default.
• W4308384789 creator A5076133160 @default.
• W4308384789 creator A5077350606 @default.
• W4308384789 creator A5079950375 @default.
• W4308384789 creator A5083626538 @default.
• W4308384789 date "2022-11-01" @default.
• W4308384789 modified "2023-10-14" @default.
• W4308384789 title "666 Phase 2, single arm study of CG0070 combined with pembrolizumab in patients with non-muscle invasive bladder cancer (NMIBC) unresponsive to bacillus calmette-guerin (BCG)" @default.
• W4308384789 doi "https://doi.org/10.1136/jitc-2022-sitc2022.0666" @default.
• W4308384789 hasPublicationYear "2022" @default.
• W4308384789 type Work @default.
• W4308384789 citedByCount "1" @default.
• W4308384789 countsByYear W43083847892023 @default.
• W4308384789 crossrefType "proceedings-article" @default.
• W4308384789 hasAuthorship W4308384789A5011089375 @default.
• W4308384789 hasAuthorship W4308384789A5019497849 @default.
• W4308384789 hasAuthorship W4308384789A5020983805 @default.
• W4308384789 hasAuthorship W4308384789A5029026130 @default.
• W4308384789 hasAuthorship W4308384789A5029221328 @default.
• W4308384789 hasAuthorship W4308384789A5034005227 @default.
• W4308384789 hasAuthorship W4308384789A5038887077 @default.
• W4308384789 hasAuthorship W4308384789A5052301584 @default.
• W4308384789 hasAuthorship W4308384789A5054735116 @default.
• W4308384789 hasAuthorship W4308384789A5076133160 @default.
• W4308384789 hasAuthorship W4308384789A5077350606 @default.
• W4308384789 hasAuthorship W4308384789A5079950375 @default.
• W4308384789 hasAuthorship W4308384789A5083626538 @default.
• W4308384789 hasBestOaLocation W43083847891 @default.
• W4308384789 hasConcept C121608353 @default.
• W4308384789 hasConcept C126322002 @default.
• W4308384789 hasConcept C126894567 @default.
• W4308384789 hasConcept C143998085 @default.
• W4308384789 hasConcept C2777701055 @default.
• W4308384789 hasConcept C2778769751 @default.
• W4308384789 hasConcept C2780057760 @default.
• W4308384789 hasConcept C2780352672 @default.
• W4308384789 hasConcept C71924100 @default.
• W4308384789 hasConcept C77411442 @default.
• W4308384789 hasConcept C90924648 @default.
• W4308384789 hasConceptScore W4308384789C121608353 @default.
• W4308384789 hasConceptScore W4308384789C126322002 @default.
• W4308384789 hasConceptScore W4308384789C126894567 @default.
• W4308384789 hasConceptScore W4308384789C143998085 @default.
• W4308384789 hasConceptScore W4308384789C2777701055 @default.
• W4308384789 hasConceptScore W4308384789C2778769751 @default.
• W4308384789 hasConceptScore W4308384789C2780057760 @default.
• W4308384789 hasConceptScore W4308384789C2780352672 @default.
• W4308384789 hasConceptScore W4308384789C71924100 @default.
• W4308384789 hasConceptScore W4308384789C77411442 @default.
• W4308384789 hasConceptScore W4308384789C90924648 @default.
• W4308384789 hasLocation W43083847891 @default.
• W4308384789 hasOpenAccess W4308384789 @default.
• W4308384789 hasPrimaryLocation W43083847891 @default.
• W4308384789 hasRelatedWork W1586830405 @default.
• W4308384789 hasRelatedWork W1976830962 @default.
• W4308384789 hasRelatedWork W2085161087 @default.
• W4308384789 hasRelatedWork W2138050084 @default.
• W4308384789 hasRelatedWork W2370208313 @default.
• W4308384789 hasRelatedWork W2433727248 @default.
• W4308384789 hasRelatedWork W3215044659 @default.
• W4308384789 hasRelatedWork W324577642 @default.
• W4308384789 hasRelatedWork W4295037691 @default.
• W4308384789 hasRelatedWork W2118673085 @default.
• W4308384789 isParatext "false" @default.
• W4308384789 isRetracted "false" @default.
• W4308384789 workType "article" @default.