QUILT-3.080: NANT Pancreatic Cancer Vaccine

Part of paid clinical trials in El Segundo, California.

Sponsor
ImmunityBio, Inc.
Study ID
NCT03586869
Phase
PHASE1/PHASE2
Status
Terminated

Conditions

Eligibility Criteria

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

Interventions

  • Aldoxorubicin HCl — DRUG
    Aldoxorubicin Hydrochloride
  • ALT-803 — BIOLOGICAL
    Recombinant human super agonist interleukin-15 (IL-15) complex
  • ETBX-011 — BIOLOGICAL
    Ad5 \[E1-, E2b-\]-CEA
  • ETBX-021 — BIOLOGICAL
    Ad5 \[E1-, E2b-\]-HER2
  • ETBX-051 — BIOLOGICAL
    Ad5 \[E1-, E2b-\]-Brachyury
  • ETBX-061 — BIOLOGICAL
    Ad5 \[E1-, E2b-\]-MUC1
  • GI-4000 — BIOLOGICAL
    RAS yeast
  • GI-6207 — BIOLOGICAL
    Carcinoembryonic Antigen (CEA) yeast
  • GI-6301 — BIOLOGICAL
    Brachyury yeast
  • haNK for infusion — BIOLOGICAL
    NK-92 \[CD16.158V, ER IL-2\]
  • bevacizumab — BIOLOGICAL
    Recombinant human anti-Vascular Endothelial Growth Factor (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
  • Oxaliplatin — DRUG
    cis-\[(1 R,2 R)-1,2-cyclohexanediamine-N,N'\] \[oxalato(2-)- O,O'\] platinum
  • Avelumab — BIOLOGICAL
    Recombinant human anti-programmed death-ligand 1 (PD-L1) IgG1 monoclonal antibody
  • 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 Standard of Care (SoC) chemotherapy.

Key Dates

First listed
Jul 16, 2018
Start date
Jul 17, 2018
Status verified
Jul 2019
Primary completion
Apr 17, 2019
Completion
Aug 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 were administered to subjects in this study: Aldoxorubicin HCl, ALT-803, ETBX-011 (CEA), ETBX-021 (HER2), ETBX-051 (Brachyury), ETBX-061 (MUC1), GI-4000, GI-6207, GI-6301, haNK for infusion, avelumab, bevacizumab, capecitabine, cyclophosphamide, fluorouracil, leucovorin, nab-paclitaxel, oxaliplatin, and Stereotactic Body Radiation Therapy (SBRT).

Primary Outcome Measure

Number of Participants With Treatment-emergent Adverse Events (AEs) and Serious AEs (SAEs) [ Time Frame: Up to 230 days ]

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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