NCT04390399

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

Open-label, Randomized, Comparative Phase 2 Study of Combination Immunotherapy Plus Standard-of-care Chemotherapy Versus Standard-of-care Chemotherapy for the Treatment of Locally Advanced or Metastatic Pancreatic Cancer

• Status: Active Not Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 328 (estimated)
• Sponsor: ImmunityBio, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is a phase 2, three-cohort (2 randomized and 1 single-arm), 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, second line, or third line or greater) will be evaluated independently as a separate cohort.

Conditions

• Pancreatic Cancer

Interventions

Type	Name	Description
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

Timeline

• Start date: 2020-07-21
• Primary completion: 2025-10-13
• Completion: 2026-05-31
• First posted: 2020-05-15
• Last updated: 2025-12-15

Locations

4 sites across 1 country: United States

Regulatory

• FDA-regulated drug study