IGF::OT::IGF VADIS TRIAL: PHASE II TRIAL OF E75 PEPTIDE VACCINE IN WOMEN WITH DCIS OF THE BREAST

University Of Tx Md Anderson Can Ctr, Houston TX

Investigators

Abstract

The proposed clinical trial will evaluate immunogenicity of E75 peptide vaccine in women with ductal carcinoma in situ in comparison to GM-CSF alone. It is a pre-surgical/ post-surgical phase IIb, randomized, multi-center study for women with histologically confirm ductal carcinoma in situ. HLA-A2+ participants who meet all other eligibility criteria will be randomized to receive NeuVaxTM (nelipepimut-S; 1000 ?g of E75 and 250 ?g of GM-CSF) or GM-CSF alone. Patients randomized to the nelipepimut-S + GM-CSF arm will receive three vaccinations of nelipepimut-S (1000 ?g) and GM-CSF (250 ?g) administered intradermally two weeks apart prior to surgery, and three vaccinations 1 month apart post surgery for six total vaccinations.