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http://hdl.handle.net/11054/2092
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DC Field | Value | Language |
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dc.contributor | Khushalani, N. | en_US |
dc.contributor | Shue, H. | en_US |
dc.contributor | Gedye, C. | en_US |
dc.contributor | Mazumder, A. | en_US |
dc.contributor | Sharma, S. | en_US |
dc.contributor | Eastgate, M. | en_US |
dc.contributor | Ascierto, P. | en_US |
dc.date.accessioned | 2023-02-06T23:02:51Z | - |
dc.date.available | 2023-02-06T23:02:51Z | - |
dc.date.issued | 2022 | - |
dc.identifier.govdoc | 02038 | en_US |
dc.identifier.uri | http://hdl.handle.net/11054/2092 | - |
dc.description.abstract | Background: HBI-8000 also known as tucidinostat is an orally bioavailable, lownanomolar inhibitor of cancer-associated histone deacetylase enzymes. HBI-8000 is a histone deacetylase inhibitor (HDACi), and as an epigenetic regulator modulating the gene expression, without changing the DNA sequence. HBI-8000 is being developed as a monotherapy for the treatment of hematological malignancies and in combinations for the treatment of solid tumors such as melanoma, breast, kidney, and lung cancers. Trial design: This is a multicenter, randomized, double-blind, placebo-controlled Phase 3 study of HBI-8000 or Placebo combined with nivolumab in patients with unresectable or metastatic melanoma not previously treated with program cell death protein 1 (PD-1) or programmed cell death-ligand 1 (PD-L1) Inhibitors (NCT04674683). Approximately 480 patients (including approximately 30 patients in special open-label, non-randomized cohort who are either adolescents 12 years of age or patients with new, progressive brain metastasis) with metastatic or unresectable melanoma who have not received anti-PD-1 or anti-PD-L1 for their disease will be enrolled. Eligible patients will be randomized within appropriate stratum at a ratio of 1:1 stratified by PD-L1 expression (positive, 1% expression level versus negative, | en_US |
dc.description.provenance | Submitted by Gemma Siemensma (gemmas@bhs.org.au) on 2023-02-06T04:31:20Z No. of bitstreams: 0 | en |
dc.description.provenance | Approved for entry into archive by Gemma Siemensma (gemmas@bhs.org.au) on 2023-02-06T23:02:51Z (GMT) No. of bitstreams: 0 | en |
dc.description.provenance | Made available in DSpace on 2023-02-06T23:02:51Z (GMT). No. of bitstreams: 0 Previous issue date: 2022 | en |
dc.title | A multicenter, randomized, double-blind phase III study of HBI-8000 combined with nivolumab versus placebo with nivolumab in patients with unresectable or metastatic melanoma not previously treated with PD-1 or PD-L1 inhibitors. | en_US |
dc.type | Conference | en_US |
dc.type.specified | Presentation | en_US |
dc.bibliographicCitation.conferencedate | December 2-4 | en_US |
dc.bibliographicCitation.conferencename | ESMO Asia Congress 2022 | en_US |
dc.bibliographicCitation.conferenceplace | Singapore | en_US |
dc.subject.healththesaurus | METASTATIC MELANOMA | en_US |
Appears in Collections: | Research Output |
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