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

Part of paid clinical trials in El Segundo, California.

Sponsor
ImmunityBio, Inc.
Study ID
NCT04390399
Phase
PHASE2
Status
Active Not Recruiting

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • N-803 — BIOLOGICAL
    Recombinant human super agonist interleukin-15 (IL-15) complex
  • Aldoxorubicin HCl — DRUG
    Aldoxorubicin hydrochloride
  • PD-L1 t-haNK — BIOLOGICAL
    PD-L1 t-haNK suspension for infusion
  • Nab-paclitaxel — DRUG
    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
  • Gemcitabine — DRUG
    2', 2'-difluoro 2'deoxycytidine, dFdC
  • Cyclophosphamide — DRUG
    2-\[bis(2-chloroethyl)amino\]tetrahydro-2H-1,3,2-oxazaphosphorine 2-oxide monohydrate
  • 5-Fluorouracil — DRUG
    5-fluoro-2,4 (1H,3H)-pyrimidinedione
  • Leucovorin — DRUG
    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
  • SBRT — PROCEDURE
    Stereotactic Body Radiation Therapy
  • Irinotecan liposome — DRUG
    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

Study Details

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.

Key Dates

Start date
Jul 21, 2020
Status verified
Oct 2025
Primary completion
Oct 13, 2025
Completion
May 31, 2026

Study Design

Enrollment
328 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Active Comparator: Cohort A Control Treatment Arm
    SBRT + gemcitabine + nab-paclitaxel
  • Experimental: Cohort A Experimental Treatment Arm 1
    SBRT + cyclophosphamide + gemcitabine + nab-paclitaxel + aldoxorubicin HCl + N-803
  • Experimental: Cohort A Experimental Treatment Arm 2
    SBRT + cyclophosphamide + gemcitabine + nab-paclitaxel+ aldoxorubicin HCl + N-803 + PD-L1 t-haNK
  • Active Comparator: Cohort B Control Treatment Arm
    Irinotecan liposome + 5-FU/leucovorin
  • Experimental: Cohort B Experimental Treatment Arm
    SBRT + cyclophosphamide + gemcitabine + nab-paclitaxel+ aldoxorubicin HCl + N-803 + PD-L1 t-haNK
  • Experimental: Cohort C Experimental Treatment Arm
    SBRT + cyclophosphamide + gemcitabine + nab-paclitaxel + aldoxorubicin + N-803 + PD-L1 t-haNK

Primary Outcome Measure

Progression Free Survival (PFS) [ Time Frame: 8 weeks ]

Locations (4)

FacilityCityStateZIPSite coordinators
Chan Soon-Shiong Institute for MedicineEl SegundoCalifornia90245-
Hoag memorial Presbyterian HospitalNewport BeachCalifornia92663-
Astera Cancer CareEast BrunswickNew Jersey08816-
Avera Cancer InstituteSioux FallsSouth Dakota57105-

Find similar trials in El Segundo, CA

By condition
Pancreatic cancer
By specialty
OncologyGI oncology
By research site
Chan Soon-Shiong Institute for Medicine· El Segundo, CAHoag memorial Presbyterian Hospital· Newport Beach, CAAstera Cancer Care· East Brunswick, NJAvera Cancer Institute· Sioux Falls, SD

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