QUILT-3.050: NANT Colorectal Cancer (CRC) Vaccine: Combination Immunotherapy in Subjects With Recurrent or Metastatic CRC

Sponsor
ImmunityBio, Inc.
Study ID
NCT03169777
Phase
PHASE1/PHASE2
Status
Withdrawn

Conditions

Eligibility Criteria

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

Interventions

  • avelumab — BIOLOGICAL
    Fully human anti-programmed death-ligand 1 (PD-L1) immunoglobulin (Ig)G1 lambda monoclonal antibody
  • bevacizumab — BIOLOGICAL
    Recombinant human anti-vascular endothelial growth factor (VEGF) IgG1 monoclonal antibody
  • capecitabine — DRUG
    5'-deoxy-5-fluoro-N-\[(pentyloxy) carbonyl\]-cytidine
  • cetuximab — BIOLOGICAL
    Recombinant human/mouse chimeric anti-epidermal growth factor receptor (EGFR) IgG1 monoclonal antibody
  • Cyclophosphamide — DRUG
    2-\[bis(2-chloroethyl)amino\]tetrahydro-2H-1,3,2-oxazaphosphorine 2-oxide monohydrate
  • 5-Fluorouracil (5-FU) — DRUG
    5-fluoro-2,4 (1H,3H)-pyrimidinedione
  • fulvestrant — DRUG
    7-alpha-\[9-(4,4,5,5,5-pentafluoropentylsulphinyl) nonyl\]estra-1,3,5-(10)- triene-3,17-beta-diol
  • leucovorin — DRUG
    Calcium N-\[p-\[\[\[(6RS)-2-amino-5-formyl-5,6,7,8-tetrahydro-4-hydroxy-6-pteridinyl\]methyl\]amino\]benzoyl\]-L-glutamate (1:1)
  • nab paclitaxel — DRUG
    5β,20-Epoxy-1,2α,4,7β,10β,13α-hexahydroxytax-11-en-9-one 4,10-diacetate 2-benzoate 13-ester with (2R,3S)-N-benzoyl-3-phenylisoserine
  • nivolumab — BIOLOGICAL
    Human anti-programmed cell death protein 1 (PD-1) IgG4 kappa monoclonal antibody
  • Lovaza — DRUG
    Omega-3-acid ethyl esters
  • oxaliplatin — DRUG
    cis-\[(1 R,2 R)-1,2-cyclohexanediamine-N,N'\] \[oxalato(2-)- O,O'\] platinum
  • Stereotactic Body Radiation Therapy — RADIATION
    (SBRT)
  • ALT-803 — BIOLOGICAL
    recombinant human super agonist interleukin-15 (IL-15) complex
  • ETBX-011 — BIOLOGICAL
    adenovirus serotype-5 \[Ad5\] \[E1-, E2b-\]-carcinoembryonic antigen \[CEA\] vaccine
  • ETBX-021 — BIOLOGICAL
    Ad5 \[E1-, E2b-\]-human epidermal growth factor receptor 2 \[HER2\] vaccine
  • ETBX-051 — BIOLOGICAL
    Ad5 \[E1-, E2b-\]-Brachyury vaccine
  • ETBX-061 — BIOLOGICAL
    Ad5 \[E1-, E2b-\]-mucin 1 \[MUC1\] vaccine
  • GI-4000 — BIOLOGICAL
    RAS yeast vaccine
  • GI-6207 — BIOLOGICAL
    CEA yeast vaccine
  • GI-6301 — BIOLOGICAL
    Brachyury yeast vaccine
  • haNK — BIOLOGICAL
    NK-92 \[CD16.158V, ER IL-2\], Suspension for Intravenous \[IV\] Infusion

Study Details

This is a phase 1b/2 study to evaluate the safety and efficacy of metronomic combination therapy in subjects with recurrent and metastatic CRC.

Key Dates

Start date
Aug 31, 2018
Status verified
Oct 2017
Primary completion
Jan 31, 2019
Completion
Dec 28, 2021

Study Design

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

Arms

  • Experimental: Nant CRC Vaccine
    avelumab, bevacizumab, capecitabine, cetuximab, cyclophosphamide, 5-fluorouracil, fulvestrant, leucovorin, nab paclitaxel, nivolumab, lovaza, oxaliplatin, stereotactic body radiation therapy, ALT-803, ETBX-011, ETBX-021, ETBX-051, ETBX-061, GI-4000, GI-6207, GI-6301, and haNK.

Primary Outcome Measure

Incidence of treatment-emergent adverse events (AEs) and serious AEs (SAEs), graded using the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) Version 4.03. [ Time Frame: 1 year ]

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