Date: 2014-09-26
Type of information: Initiation of the trial
phase: 1b/3
Announcement: initiation of the trial
Company: Amgen (USA - CA) Merck&Co (USA - NJ)
Product: Keytruda® (pembrolizumab) and talimogene Laherparepvec
Action
mechanism: monoclonal antibody/immune checkpoint inhibitor/oncolytic virus/immunotherapy product. Keytruda® (pembrolizumab - MK-3475) is an highly selective monoclonal anti-PD-1 antibody designed to restore the natural ability of the immune system to recognize and target cancer cells by selectively achieving dual ligand blockade (PD-L1 and PD-L2) of the PD-1 protein. By blocking PD-1, pembrolizumab enables activation of the immune system’s T-cells that target cancer by essentially releasing a brake on the immune system. Talimogene laherparepvec is an investigational oncolytic immunotherapy designed to selectively replicate in tumors (but not normal tissue) and to initiate an immune response to target cancer cells that have metastasized. Talimogene laherparepvec was designed to work in two important and complementary ways. First, it is injected directly into tumors where it replicates inside the tumor's cells causing the cell to rupture and die in a process called lysis. The rupture of the cancer cells can release tumor-derived antigens, along with GM-CSF, that can stimulate a system-wide immune response where white blood cells are able to seek out and target cancer that has spread throughout the body.
Disease: melanoma
Therapeutic area: Cancer - Oncology
Country: Australia, Austria, Belgium, Canada, Germany, Greece, Poland, Spain, Switzerland, UK, USA
Trial
details: The MASTERKEY-265 Phase 1b/3 trial is evaluting talimogene laherparepvec in combination with pembrolizumab (MK-3475) for the treatment of unresectable stage IIIB to IVM1c melanoma. Phase 1b Subjects will be treated with talimogene laherparepvec until all injectable tumors have disappeared, disease progression per modified Immune-Related Response Criteria (irRC), or intolerance of study treatment, up to a maximum of 24 months of study treatment. Subjects will be treated with MK-3475 (pembrolizumab) until complete response (CR) disease progression per irRC, or intolerance of study treatment, up to a maximum of 24 months of study treatment. In Phase 3, Subjects will be treated with talimogene laherparepvec plus pembrolizumab(arm 1) or placebo plus pembrolizumab (arm 2) until 24 months from the date of the first dose of pembrolizumab or end of treatment due to disappearance of injectable lesions, complete response, disease progression per irRC-RECIST or intolerance of study treatment. (NCT02263508 )
Latest
news: * On September 26, 2014, a Phase 3 trial sponsored by Amgen and Merck&Co was published on the NIH website ClinicalTrials.gov for pembrolizumab and talimogene Laherparepvec is currently recruiting participants.
