Phase II, Open-label, Randomized, Comparative Study of Combination Immunotherapy Plus Standard-of-Care Chemotherapy Versus Standard-of-Care Chemotherapy for the Treatment of Locally Advanced or Metastatic Pancreatic Cancer
Summary
This is a phase II, three-cohort (2 randomized and 1 single-arm), two-cohort, open-label study to evaluate the comparative efficacy and overall safety of standard-of-care chemotherapy versus standard-of-care chemotherapy in combination with aldoxorubicin HCl, N-803, and PD-L1 t-haNK in subjects with locally advanced or metastatic pancreatic cancer. Each treatment setting (ie, first line maintenance, or second line, or later third line or greater) will be evaluated independently as a separate cohort.
General Information
NCT#: NCT04390399
Study ID: QUILT-88
Trial Phase: Phase II
Trial Sponsor: ImmunityBio, Inc.
Therapies Used in This Trial: Nab-paclitaxel, Fluorouracil, Gemcitabine, Stereotactic body radiotherapy (SBRT), Cyclophosphamide, Leucovorin, irinotecan liposome injection, Aldoxorubicin, ALT-803/N-803, PD-L1 haNK