QUILT-3.047: NANT Head and Neck Squamous Cell Carcinoma (HNSCC) Vaccine: Combination Immunotherapy in Subjects With HNSCC Who Have Progressed on or After Chemotherapy and PD-1/PD-L1 Therapy

Sponsor
ImmunityBio, Inc.
Study ID
NCT03169764
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Withdrawn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-PD-L1 IgG1 lambda monoclonal antibody
  • Bevacizumab — BIOLOGICAL
    Recombinant human anti-vascular endothelial growth factor (VEGF) immunoglobulin (Ig) G1 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
  • Cisplatin — DRUG
    (SP-4-2)-diamminedichloroplatinum(II)
  • 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-PD-1 IgG4 kappa monoclonal antibody
  • Lovaza — DRUG
    Omega-3-acid ethyl esters
  • Stereotactic Body Radiation Therapy — RADIATION
    (SRBT)
  • ALT-803 — BIOLOGICAL
    recombinant human super agonist interleukin-15 (IL-15) complex \[also known as IL 15N72D:IL-15RαSu/IgG1 Fc complex\]
  • 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 HNSCC who have progressed on or after previous chemotherapy and anti-PD-1/PD-L1 therapy.

Key Dates

Start date
Dec 31, 2017
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 HNSCC Vaccine
    avelumab, bevacizumab, capecitabine, cetuximab, cisplatin, cyclophosphamide, 5-fluorouracil, fulvestrant, leucovorin, nab-paclitaxel, nivolumab, lovaza, 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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