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

NANT Head and Neck Squamous Cell Carcinoma (HNSCC) Vaccine: Combination Immunotherapy in Subjects With HNSCC Who Have Progressed on or After Chemotherapy and Anti-programmed Cell Death Protein 1 (PD-1)/Programmed Death-ligand 1 (PD-L1) Therapy

• Status: Withdrawn
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: ImmunityBio, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

Treatment will be administered in two phases, an induction and a maintenance phase. Subjects will continue induction treatment for up to 1 year or until they experience progressive disease (PD) or unacceptable toxicity (not correctable with dose reduction), withdraw consent, or if the Investigator feels it is no longer in the subject's best interest to continue treatment. Those who have a complete response (CR) in the induction phase will enter the maintenance phase of the study. Subjects may remain in the maintenance phase of the study for up to 1 year. Treatment will continue in the maintenance phase until the subject experiences PD or unacceptable toxicity (not correctable with dose reduction), withdraws consent, or if the Investigator feels it is no longer in the subject's best interest to continue treatment.

Conditions

• Head and Neck Squamous Cell Carcinoma

Interventions

Type	Name	Description
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

Timeline

• Start date: 2017-12-01
• Primary completion: 2019-01-01
• Completion: 2021-12-28
• First posted: 2017-05-30
• Last updated: 2025-02-24

Regulatory

• FDA-regulated drug study