Trial to evaluate the immunogenicity and safety of a melanoma helper peptide vaccine plus incomplete Freund's adjuvant, cyclophosphamide, and polyICLC (Mel63).

Craig L SlingluffGina R PetroniKimberly A Chianese-BullockNolan A WagesWalter C OlsonKelly T SmithKathleen HadenLynn T DengelAnna DickinsonCaroline ReedElizabeth M GaughanWilliam W GroshVarinder KaurNikole VarhegyiMark SmolkinNadejda V GaleassiDonna DeaconEmily H Hall

Published in: Journal for immunotherapy of cancer (2021)

6MHP vaccines administered with IFA, polyICLC, and mCy were well tolerated. The dRsp rate for arm D of 47% (90% CI 32 to 63) exceeded the 18% (90% CI 11 to 26) rate previously observed with 6MHP in IFA alone. Vaccination with IFA+ polyICLC (arm C) also showed promise for enhancing T cell and Ab responses.

Keyphrases

early stage
low dose
study protocol

high dose
regulatory t cells
phase iii

dendritic cells
big data
randomized controlled trial

phase ii
machine learning
placebo controlled