Combination Immunotherapy With Herceptin and the HER2 Vaccine NeuVax
Status:
Completed
Trial end date:
2018-09-28
Target enrollment:
Participant gender:
Summary
The study will be a multi-center, prospective, randomized, single-blinded, placebo-controlled
Phase II trial of Herceptin + NeuVax(TM) vaccine (E75 peptide/granulocyte macrophage-colony
stimulating factor) (GM-CSF) versus Herceptin + GM-CSF alone. The target study population is
node-positive (NP) (or node-negative [NN] if negative for both ER and PR) breast cancer
patients with HER2 1+ and 2+ expressing tumors who are disease-free after standard of care
therapy. Disease-free subjects after standard of care multi-modality therapy will be screened
and HLA-typed. E75 is a CD8-eliciting peptide vaccine that was restricted to HLA-A2+ or
HLA-A3+ patients (approximately two-thirds of the US population), and has been extended to
HLA-A24+ and HLA-A26+ as well.
Phase:
Phase 2
Details
Lead Sponsor:
George E. Peoples
Collaborators:
Galena Biopharma, Inc. Genentech, Inc. Sellas Life Sciences Group