QUILT-3.046: NANT Melanoma Vaccine: Combination Immunotherapy in Subjects With Melanoma Who Have Progressed On or After Chemotherapy and PD-1/PD-L1 Therapy

Sponsor
ImmunityBio, Inc.
Study ID
NCT03167177
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Withdrawn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
  • 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 — DRUG
    5-fluoro-2,4 (1H,3H)-pyrimidinedione
  • 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
    Recombinant human anti-PD-1 IgG4 monoclonal antibody
  • omega-3-acid ethyl esters — DRUG
    Omega-3-acid ethyl esters
  • Stereotactic Body Radiation Therapy — RADIATION
    radiation
  • ALT-803 — BIOLOGICAL
    Recombinant human super agonist interleukin-15 (IL-15) complex
  • ETBX-011 — BIOLOGICAL
    Ad5 \[E1-, E2b-\]-CEA
  • ETBX-051 — BIOLOGICAL
    Ad5 \[E1-, E2b-\]-Brachyury
  • ETBX-061 — BIOLOGICAL
    Ad5 \[E1-, E2b-\]-MUC1
  • GI-6207 — BIOLOGICAL
    Heat-killed S. cerevisiae yeast expressing CEA
  • GI-6301 — BIOLOGICAL
    Heat-killed S. cerevisiae yeast expressing the human Brachyury (hBrachyury) oncoprotein
  • haNK — BIOLOGICAL
    NK-92 \[CD16.158V, ER IL-2\] (high-affinity activated Natural Killer cells)

Study Details

This is a phase 1b/2 study to evaluate the safety and efficacy of metronomic combination therapy in subjects with melanoma who have progressed on or after 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 Melanoma Vaccine
    A combination of agents will be administered to subjects in this study: avelumab, bevacizumab, capecitabine, cisplatin, cyclophosphamide, 5-fluorouracil, leucovorin, nab-paclitaxel, nivolumab, omega-3-acid ethyl esters, stereotactic body radiation therapy, ALT-803, ETBX-011, ETBX-051, ETBX-061, GI-6207, GI-6301, and haNK.

Primary Outcome Measure

Incidence of treatment-emergent Adverse Events (AEs) and Serious Adverse Events (SAEs), graded using the NCI CTCAE Version 4.03. [ Time Frame: 1 year ]

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