Date: 2016-06-02
Type of information: Clinical trial autorization
phase: 1
Announcement: clinical trial authorization
Company: Targovax (Norway)
Product: TG02 and pembrolizumab
Action
mechanism: peptide/immunotherapy product/monoclonal antibody/immune checkpoint inhibitor. TG02 is a cancer vaccine containing a mixture of 8 synthetic peptides representing fragments of the most common RAS mutations seen in colorectal cancer disease. Mutations in RAS is seen in about 50% of patients with colorectal cancer and 20-30% of all cancers. It is associated with a lack of response to chemotherapy and poor prognosis. Previous and ongoing clinical studies have shown that TG peptides are able to induce RAS mutation specific immune responses. Keytruda® (pembrolizumab - MK-3475) is a 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.
Disease: locally recurrent RAS mutated rectal cancer
Therapeutic area: Cancer - Oncology
Country: Australia, New Zealand
Trial
details: The purpose of this study is to determine safety and anti-tumor immune activation generated by TG02 and Granulocyte macrophage colony stimulating factor (GM-CSF), first as monotherapy (Part I), thereafter in combination with the checkpoint inhibitor pembrolizumab (Part II), in patients with locally recurrent rectal cancer scheduled to have surgery. Part I and Part II will include approximately 10 patients each. Part I and Part II are separate and independent sequential components of the study. Patients will only be able to participate in either the Part I cohort or Part II cohort. Main objective of the study is to investigate safety and immune response after TG02-treatment. (NCT02933944)
Latest
news: * On June 2, 2016, Targovax receives approval to conduct a study with TG02 and pembrolizumab, in patients with locally recurrent RAS mutated rectal cancer. This will be the first study with TG02 in humans and 20 patients will be included at Australian sites. The study will assess safety and immune activation, both at lesional level and in peripheral blood. One cohort will only receive TG02 and another cohort will receive TG02 in combination with pembrolizumab, a PD-1 receptor inhibitor.
