QUILT-3.060: NANT Pancreatic Cancer Vaccine: Molecularly Informed Integrated 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
NCT03329248
Phase
PHASE1/PHASE2
Status
Terminated

Conditions

Eligibility Criteria

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

Interventions

  • ALT-803 — BIOLOGICAL
    Recombinant human super agonist interleukin-15 (IL-15) complex
  • ETBX-011 — BIOLOGICAL
    Ad5 \[E1-, E2b-\]-CEA
  • GI-4000 — BIOLOGICAL
    Vaccine derived from recombinant Saccharomyces cerevisiae yeast expressing mutant Ras proteins
  • haNK for infusion — BIOLOGICAL
    NK-92 \[CD16.158V, ER IL-2\]
  • avelumab — BIOLOGICAL
    Recombinant human anti-PD-L1 IgG1 monoclonal antibody
  • bevacizumab — BIOLOGICAL
    Recombinant human anti-VEGF IgG1 monoclonal
  • Capecitabine — DRUG
    5'-deoxy-5-fluoro-N-\[(pentyloxy) carbonyl\]-cytidine
  • Cyclophosphamide — DRUG
    2-\[bis(2-chloroethyl)amino\]tetrahydro-2H-1,3,2-oxazaphosphorine 2-oxide monohydrate
  • 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
  • lovaza — DRUG
    Omega-3-acid ethyl esters
  • Oxaliplatin — DRUG
    cis-\[(1 R,2 R)-1,2-cyclohexanediamine-N,N'\] \[oxalato(2-)- O,O'\] platinum
  • SBRT — PROCEDURE
    Stereotactic Body Radiation Therapy

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 SoC chemotherapy. Phase 2 will be based on Simon's two-stage optimal design.

Key Dates

First listed
Nov 1, 2017
Start date
Nov 6, 2017
Status verified
Dec 2024
Primary completion
Aug 13, 2018
Completion
Nov 1, 2019

Study Design

Enrollment
6 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: ALT-803, ETBX-011, GI-4000, haNK, avelumab, bevacizumab, capecitabine, cyclophosphamide, fluorouracil, leucovorin, nab-paclitaxel, omega-3-acid ethyl esters, oxaliplatin, SBRT

Primary Outcome Measure

Number of Participants With Treatment-emergent Adverse Events (AEs) and Serious AEs (SAEs) [ Time Frame: 30 days after last dose, up to 2 years (up to 1 year in each treatment phase) or until they experience confirmed progressive disease or unacceptable toxicity, withdrawn consent, or if the Investigator feels it is no longer in their best interest. ]

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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