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

PHASE1/PHASE2WithdrawnINTERVENTIONAL
0
Timeline

Start Date

December 31, 2017

Primary Completion Date

January 31, 2019

Study Completion Date

December 28, 2021

Conditions
Head and Neck Squamous Cell Carcinoma
Interventions
BIOLOGICAL

Avelumab

Fully human anti-PD-L1 IgG1 lambda monoclonal antibody

BIOLOGICAL

Bevacizumab

Recombinant human anti-vascular endothelial growth factor (VEGF) immunoglobulin (Ig) G1 monoclonal antibody

DRUG

Capecitabine

5'-deoxy-5-fluoro-N-\[(pentyloxy) carbonyl\]-cytidine

BIOLOGICAL

Cetuximab

Recombinant human/mouse chimeric anti-epidermal growth factor receptor (EGFR) IgG1 monoclonal antibody

DRUG

Cisplatin

(SP-4-2)-diamminedichloroplatinum(II)

DRUG

cyclophosphamide

2-\[bis(2-chloroethyl)amino\]tetrahydro-2H-1,3,2-oxazaphosphorine 2-oxide monohydrate

DRUG

5-Fluorouracil (5-FU)

5-fluoro-2,4 (1H,3H)-pyrimidinedione

DRUG

fulvestrant

7-alpha-\[9-(4,4,5,5,5-pentafluoropentylsulphinyl) nonyl\]estra-1,3,5-(10)- triene-3,17-beta-diol

DRUG

leucovorin

Calcium N-\[p-\[\[\[(6RS)-2-amino-5-formyl-5,6,7,8-tetrahydro-4-hydroxy-6-pteridinyl\]methyl\]amino\]benzoyl\]-L-glutamate (1:1)

DRUG

nab-paclitaxel

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

BIOLOGICAL

nivolumab

Human anti-PD-1 IgG4 kappa monoclonal antibody

DRUG

Lovaza

Omega-3-acid ethyl esters

RADIATION

Stereotactic Body Radiation Therapy

(SRBT)

BIOLOGICAL

ALT-803

recombinant human super agonist interleukin-15 (IL-15) complex \[also known as IL 15N72D:IL-15RαSu/IgG1 Fc complex\]

BIOLOGICAL

ETBX-011

adenovirus serotype-5 \[Ad5\] \[E1-, E2b-\]-carcinoembryonic antigen (CEA) vaccine

BIOLOGICAL

ETBX-021

Ad5 \[E1-, E2b-\]-human epidermal growth factor receptor 2 (HER2) vaccine

BIOLOGICAL

ETBX-051

Ad5 \[E1-, E2b-\]-Brachyury vaccine

BIOLOGICAL

ETBX-061

Ad5 \[E1-, E2b-\]-mucin 1 (MUC1) vaccine

BIOLOGICAL

GI-4000

Ras yeast vaccine

BIOLOGICAL

GI-6207

CEA yeast vaccine

BIOLOGICAL

GI-6301

Brachyury yeast vaccine

BIOLOGICAL

haNK

NK-92 \[CD16.158V, ER IL-2\], Suspension for Intravenous \[IV\] Infusion

Sponsors

Lead Sponsor

All Listed Sponsors
lead

ImmunityBio, Inc.

INDUSTRY

NCT03169764 - 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 | Biotech Hunter | Biotech Hunter