Combination Immunotherapy With Herceptin and the HER2 Vaccine NeuVax

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.

Timeline

Start

2013-05-21

Primary completion

2018-09-28

Completion

2018-09-28

Outcome

Missed primary endpoint

registry Herceptin + NeuVax Vaccine vs Herceptin + GM-CSF Only; p = 0.18; Hazard Ratio (HR) 0.62 (95% CI .31 to 1.25) NCT01570036 ↗

paper estimated DFS did not significantly differ between NPS and control [HR, 0.62; 95% confidence interval (CI), 0.31-1.25; P = 0.18]. PMID 32071118 ↗

Publications

• Clifton GT, Hale D, Vreeland TJ, Hickerson AT, Litton JK, Alatrash G, Murthy RK, Qiao N, Philips AV, Lukas JJ, Holmes JP, Peoples GE, Mittendorf EA. Results of a Randomized Phase IIb Trial of Nelipepimut-S + Trastuzumab versus Trastuzumab to Prevent Recurrences in Patients with High-Risk HER2 Low-Expressing Breast Cancer. Clin Cancer Res. 2020 Jun 1;26(11):2515-2523. doi: 10.1158/1078-0432.CCR-19-2741. Epub 2020 Feb 18.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Nelipepimut-S	Vaccine	1000 ug	—
Background	GM-CSF	Protein / enzyme biologic	250 ug	Intravenous
Background	Trastuzumab	Monoclonal antibody	6 mg/kg	—

Indications