QUILT-3.051: NANT Ovarian Cancer Vaccine: Combination Immunotherapy in Subjects With Epithelial Ovarian Cancer Who Have Progressed on or After Standard-of-care (SoC) Therapy

Sponsor
ImmunityBio, Inc.
Study ID
NCT03197584
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Withdrawn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-VEGF IgG1 monoclonal antibody
  • 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
  • 5-fluorouracil — 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)
  • 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
  • omega-3 acid ethyl esters — 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
    Stereotactic Body Radiation Therapy (SBRT)
  • ALT-803 — BIOLOGICAL
    Recombinant human super agonist IL-15 complex
  • ETBX-021 — BIOLOGICAL
    Ad5 \[E1-, E2b-\]-HER2 vaccine
  • ETBX-051 — BIOLOGICAL
    Ad5 \[E1-, E2b-\]-Brachyury vaccine
  • ETBX-061 — BIOLOGICAL
    Ad5 \[E1-, E2b-\]-MUC1 vaccine
  • GI-4000 — BIOLOGICAL
    Heat-killed S. cerevisiae yeast expressing the mutated RAS oncoproteins
  • GI-6301 — BIOLOGICAL
    Heat-killed S. cerevisiae yeast expressing the human Brachyury (hBrachyury) oncoprotein
  • haNK® — BIOLOGICAL
    NK-92 \[CD16.158V, ER IL-2\]

Study Details

This is a phase 1b/2 study to evaluate the safety and efficacy of metronomic combination therapy in subjects with epithelial ovarian cancer who have progressed on or after SoC therapy.

Key Dates

First listed
Jun 23, 2017
Start date
Dec 31, 2017
Status verified
Oct 2017
Primary completion
Feb 28, 2019
Completion
Dec 28, 2021

Study Design

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

Arms

  • Experimental: NANT Ovarian Cancer Vaccine
    avelumab, bevacizumab, capecitabine, cyclophosphamide, 5-fluorouracil, fulvestrant, leucovorin, paclitaxel, omega-3-acid ethyl esters, oxaliplatin, stereotactic body radiation therapy, ALT-803, ETBX-021, ETBX-051, ETBX-061, GI-4000, GI-6301, and hank®.

Primary Outcome Measure

Incidence of treatment-emergent adverse events (AEs) and serious AE (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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