OPTIM trial: a Phase III trial of an oncolytic herpes virus encoding GM-CSF for unresectable stage III or IV melanoma.
There are few effective treatment options available for patients with advanced melanoma. An oncolytic herpes simplex virus type 1 encoding granulocyte macrophage colony-stimulating factor (GM-CSF; Oncovex(GM-CSF)) for direct injection into accessible melanoma lesions resulted in a 28% objective response rate in a Phase II clinical trial. Responding patients demonstrated regression of both injected and noninjected lesions highlighting the dual mechanism of action of Oncovex(GM-CSF) that includes both a direct oncolytic effect in injected tumors and a secondary immune-mediated anti-tumor effect on noninjected tumors. Based on these preliminary results a prospective, randomized Phase III clinical trial in patients with unresectable Stage IIIb or c and Stage IV melanoma has been initiated. The rationale, study design, end points and future development of the Oncovex(GM-CSF) Pivotal Trial in Melanoma (OPTIM) trial are discussed in this article.
Kaufman
Howard L
HL
The Tumor Immunology Laboratory & Department of General Surgery, Rush University Medical Center, Chicago, IL 60612, USA. howard_l_kaufman@rush.edu
Bines
Steven D
SD
D000818:Animals; D002985:Clinical Protocols; D003588:Cytopathogenic Effect, Viral; D003673:Defective Viruses / Q000235:genetics / Q000502:physiology; D015316:Genetic Therapy; D005822:Genetic Vectors / Q000008:administration & dosage / Q000502:physiology / Q000627:therapeutic use*; D016178:Granulocyte-Macrophage Colony-Stimulating Factor / Q000008:administration & dosage / Q000235:genetics / Q000627:therapeutic use*; D018259:Herpesvirus 1, Human / Q000235:genetics* / Q000502:physiology; D006801:Humans; D015552:Injections, Intralesional; D008545:Melanoma / Q000628:therapy*; D051379:Mice; D018579:Patient Selection; D011446:Prospective Studies; D012107:Research Design; D014779:Virus Replication
D016178:Granulocyte-Macrophage Colony-Stimulating Factor