A Phase I/III, multicenter, open-label trial of talimogene laherparepvec (T-VEC) in combination with pembrolizumab for the treatment of unresected, stage IIIb-IV melanoma (MASTERKEY-265)
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چکیده
A Phase I/III, multicenter, open-label trial of talimogene laherparepvec (T-VEC) in combination with pembrolizumab for the treatment of unresected, stage IIIb-IV melanoma (MASTERKEY-265) Georgina V Long, Reinhard Dummer, Antoni Ribas, Igor Puzanov, Olivier Michielin, Ari VanderWalde, Robert HI Andtbacka, Jonathan Cebon, Eugenio Fernandez, Josep Malvehy, Anthony J Olszanski, Thomas F Gajewski, John M Kirkwood, Olga Kuznetsova, Lisa Chen, David R Kaufman, Jeffrey Chou, F Stephen Hodi
منابع مشابه
Association between durable response (DR) and overall survival (OS) in patients with unresected stage IIIb-IV melanoma treated with Talimogene Laherparepvec (T-VEC) in the Phase III OPTiM trial
Background T-VEC is an HSV-1-derived oncolytic immunotherapy designed to selectively replicate within tumors, produce GM-CSF and enhance systemic antitumor immune responses. In OPTiM (NCT00769704), a randomized Phase III trial of intralesional T-VEC vs subcutaneous GM-CSF for unresected stage IIIB-IV melanoma, TVEC significantly improved DR rate (partial response or complete response lasting co...
متن کاملFinal planned overall survival (OS) from OPTiM, a randomized Phase III trial of talimogene laherparepvec (T-VEC) versus GM-CSF for the treatment of unresected stage IIIB/C/IV melanoma (NCT00769704)
Robert HI Andtbacka, Huntsman Cancer Institute Frances A. Collichio, University of North Carolina at Chapel Hill Thomas Amatruda, Minnesota Oncology Neil Senzer, Mary Crowley Cancer Research Center Jason Chesney, University of Louisville Keith Delman, Emory University Lynn Spitler, Northern California Melanoma Center Igor Puzanov, Vanderbilt University Medical Center Sanjiv Agarwala, St. Luke's...
متن کاملTalimogene Laherparepvec Improves Durable Response Rate in Patients With Advanced Melanoma.
PURPOSE Talimogene laherparepvec (T-VEC) is a herpes simplex virus type 1-derived oncolytic immunotherapy designed to selectively replicate within tumors and produce granulocyte macrophage colony-stimulating factor (GM-CSF) to enhance systemic antitumor immune responses. T-VEC was compared with GM-CSF in patients with unresected stage IIIB to IV melanoma in a randomized open-label phase III tri...
متن کاملPhase 1 results of a phase 1b/2, multicenter, open-label trial to evaluate safety and efficacy of talimogene laherparepvec (T-VEC) and ipilimumab (ipi) vs ipi alone in previously untreated, unresected stage IIIB-IV melanoma
Methods In this 2-part study (NCT01740297), phase 1b evaluated the safety of T-VEC in combination with ipi as assessed by the incidence of dose-limiting toxicities (DLTs) at full doses of both agents. For 6 to 9 patients (pts) evaluable for DLT, approximately 18 pts were to be enrolled in phase 1b. DLTs were defined as any grade (gr) ≥ 3 immune-related adverse event (AE) or gr ≥ 4 AE of any eti...
متن کاملCutaneous head and neck melanoma in OPTiM, a randomized phase 3 trial of talimogene laherparepvec versus granulocyte‐macrophage colony‐stimulating factor for the treatment of unresected stage IIIB/IIIC/IV melanoma
BACKGROUND Cutaneous head and neck melanoma has poor outcomes and limited treatment options. In OPTiM, a phase 3 study in patients with unresectable stage IIIB/IIIC/IV melanoma, intralesional administration of the oncolytic virus talimogene laherparepvec improved durable response rate (DRR; continuous response ≥6 months) compared with subcutaneous granulocyte-macrophage colony-stimulating facto...
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