Combination Immunotherapy Plus Standard-of-Care Chemotherapy Versus Standard-of-Care Chemotherapy for the Treatment of Locally Advanced or Metastatic Pancreatic Cancer

PHASE2Active, not recruitingINTERVENTIONAL
Enrollment

328

Participants

Timeline

Start Date

July 21, 2020

Primary Completion Date

October 31, 2025

Study Completion Date

October 31, 2025

Conditions
Pancreatic Cancer
Interventions
BIOLOGICAL

N-803

Recombinant human super agonist interleukin-15 (IL-15) complex

DRUG

Aldoxorubicin HCl

Aldoxorubicin hydrochloride

BIOLOGICAL

PD-L1 t-haNK

PD-L1 t-haNK suspension for infusion

DRUG

Nab-paclitaxel

Benzenepropanoic acid, β-(benzoylamino)-α-hydroxy-(2aR, 4S, 4aS, 6R, 9S, 11S, 12S, 12aR, 12bS)-6,12b-bis(acetyloxy)-12-(benzoyloxy)-2a, 3, 4, 4a, 5, 6, 9, 10, 11, 12, 12a, 12b-dodecahydro-4,11-dihydroxy-4a, 8, 13, 13-tetramethyl-5-oxo-7,11-methano-1H-cyclodeca\[3,4\]benz\[1,2-b\]oxet-9-y1ester,(αR,βS)-(9CI) bound to albumin

DRUG

Gemcitabine

2', 2'-difluoro 2'deoxycytidine, dFdC

DRUG

Cyclophosphamide

2-\[bis(2-chloroethyl)amino\]tetrahydro-2H-1,3,2-oxazaphosphorine 2-oxide monohydrate

DRUG

5-Fluorouracil

5-fluoro-2,4 (1H,3H)-pyrimidinedione

DRUG

Leucovorin

L-Glutamic acid, N-\[4-\[\[(2-amino-5-formyl-1,4,5,6,7,8-hexahydro-4-oxo-6-pteridinyl)methyl\]amino\]benzoyl\]-, calcium salt

PROCEDURE

SBRT

Stereotactic Body Radiation Therapy

DRUG

Irinotecan liposome

Irinotecan hydrochloride trihydrate is (S)-4,11-diethyl-3,4,12,14-tetrahydro-4-hydroxy-3,14-dioxo1H-pyrano\[3',4':6,7\]-indolizino\[1,2-b\]quinolin-9-yl-\[1,4'bipiperidine\]-1'-carboxylate, monohydrochloride, trihydrate

Trial Locations (4)

57105

Avera Cancer Institute, Sioux Falls

90245

Chan Soon-Shiong Institute for Medicine, El Segundo

92663

Hoag memorial Presbyterian Hospital, Newport Beach

08816

Astera Cancer Care, East Brunswick

Sponsors

Lead Sponsor

All Listed Sponsors
lead

ImmunityBio, Inc.

INDUSTRY