![]() Patients will initially be recruited into Cohort 1. Cohort 3 will escalate all 3 agents to the full 100% dose level to assure safety for expanded analyses of clinical and laboratory data at that dose level. Cohort 2 will then add anti-GD2 to the drug combination, assessing safety and tolerability. As safety of Nivolumab is well established, Cohort 1 will assess its safety and tolerability in combination with 131-l mlBG. duration, number of treatments) without undermining its validity or integrity. Such design uses accumulating of data from the ongoing trial to modify aspects of the study (e.g. The estimated duration of the study is 2 years, starting in December 2016. This study is sponsored by the University Hospital Southampton and will take place in 4 hospitals in the United Kingdom, Germany and USA. In particular it will be determined the safety and tolerability of the novel combination as well as documented any evidence of efficacy in paediatric patients with relapsed and refractory high risk neuroblastoma. ![]() In this research the anti-GD2 antibody, which is a standard treatment, is to be combined with 131-l Metaiodobenzylguanidine (mlBG) and anti-Programmed Cell Death Protein 1 (anti-PD1) antibody Nivolumab - the investigated drugs - with the aim of generating sustained anti-neuroblastoma immunity. A promising way to further improve outcome in this disease appears to be the development of adjuvant therapeutic strategies. Neuroblastoma, the most common extra-cranial solid tumour in children, remains one of the major challenges in paediatric oncology. Why Should I Register and Submit Results?. ![]()
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