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

Powel Brown

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Funding source

National Institutes of Health (NIH)
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 μg of E75 and 250 μg of GM-CSF) or GM-CSF alone. Patients randomized to the nelipepimut-S + GM-CSF arm will receive three vaccinations of nelipepimut-S (1000 μg) and GM-CSF (250 μg) administered intradermally two weeks apart prior to surgery, and three vaccinations 1 month apart post surgery for six total vaccinations.

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