QUILT-3.039: NANT Pancreatic Cancer Vaccine: Combination Immunotherapy in Subjects With Pancreatic Cancer Who Have Progressed on or After Standard-of-care Therapy

Part of paid clinical trials in El Segundo, California.

Sponsor
ImmunityBio, Inc.
Study ID
NCT03136406
Phase
PHASE1/PHASE2
Status
Terminated

Conditions

Eligibility Criteria

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

Interventions

  • Cyclophosphamide — DRUG
    2-\[bis(2-chloroethyl)amino\]tetrahydro-2H-1,3,2-oxazaphosphorine 2-oxide monohydrate
  • Oxaliplatin — DRUG
    cis-\[(1 R,2 R)-1,2-cyclohexanediamine-N,N'\] \[oxalato(2-)- O,O'\] platinum
  • Capecitabine — DRUG
    5'-deoxy-5-fluoro-N-\[(pentyloxy) carbonyl\]-cytidine
  • 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
  • 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
  • bevacizumab — BIOLOGICAL
    Recombinant human anti-VEGF IgG1 monoclonal
  • avelumab — BIOLOGICAL
    Recombinant human anti-PD-L1 IgG1 monoclonal antibody
  • ALT-803 — BIOLOGICAL
    Recombinant human super agonist interleukin-15 (IL-15) complex
  • aNK for Infusion — BIOLOGICAL
    NK-92 cells
  • ETBX-011 — BIOLOGICAL
    Ad5 \[E1-, E2b-\]-CEA
  • GI-4000 — BIOLOGICAL
    Vaccine derived from recombinant Saccharomyces cerevisiae yeast expressing mutant Ras proteins

Study Details

This is a phase 1b/2 study to evaluate the safety and efficacy of metronomic combination therapy in subjects with pancreatic cancer who have progressed on or after previous Standard of Care first line therapy and chemotherapy.

Key Dates

First listed
May 2, 2017
Start date
Aug 11, 2017
Status verified
Apr 2024
Primary completion
Nov 22, 2017
Completion
Nov 1, 2019

Study Design

Enrollment
3 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: NANT Pancreatic Cancer Vaccine
    A combination of agents will be administered to subjects in this study: cyclophosphamide, oxaliplatin, capecitabine, fluorouracil, leucovorin, nab-paclitaxel, bevacizumab, avelumab, ALT-803, aNK, GI-4000, and ETBX-011.

Primary Outcome Measure

Number of Participants With Adverse Events [ Time Frame: 30 days after last dose, up to 2 years ]

Locations (1)

FacilityCityStateZIPSite coordinators
Chan Soon-Shiong Institute for MedicineEl SegundoCalifornia90245-

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, CA

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