Drugs / Nelipepimut-S

Trials 4 · a red edge is where a trial was stopped

2012201320142015201620172018201920202021202220232024202520262027
PhaseRegistry idDatesIndicationSponsorStatusOutcome
Phase 23 trials
Phase 2 NCT02636582 Jun 2016 → Jul 2019 ductal breast carcinoma in situ National Cancer Institute (NCI) Completed No outcome recorded
Phase 2 NCT02297698 Oct 2014 → Dec 2021 breast cancer Cancer Insight, LLC Completed No outcome recorded
Phase 2 NCT01570036 May 2013 → Sep 2018 breast cancer George E. Peoples Completed No outcome recorded
Phase 31 trial
Phase 3 NCT01479244 Nov 2011 → Sep 2016 breast carcinoma by gene expression profile Galena Biopharma, Inc. Completed No outcome recorded

Evidence & citations 4 cited values

Every value below carries the sentence it was read from. 4 sources stand behind the page.

FieldValueCited text
Known as nelipepimut-S “Efficacy and Safety Analysis of Nelipepimut-S Vaccine to Prevent Breast Cancer Recurrence: A Randomized, Multicenter, Phase III Clinical Trial.” PMID 31036542 Apr 2019
3

“Patients received trastuzumab for 1 year and were randomized to placebo (GM-CSF, control) or nelipepimut-S (NPS) with GM-CSF.” PMID 32071118 Feb 2020

Nelipepimut-S is a CD8-eliciting peptide vaccine” NCT02297698

NCT02636582

Known as NP-S “In phase I/II studies, nelipepimut-S (NP-S) plus GM-CSF vaccine was well tolerated and effectively raised HER2-specific immunity in patients with breast cancer.” PMID 31036542 Apr 2019
1

“Patients received trastuzumab for 1 year and were randomized to placebo (GM-CSF, control) or nelipepimut-S (NPS) with GM-CSF.” PMID 32071118 Feb 2020

Modality Vaccine “Nelipepimut-S is a CD8-eliciting peptide vaccineNCT02297698
Route Other “nelipepimut-S (1000 mcg) and GM-CSF (250 mcg) administered intradermally every three weeks” NCT02297698