QUILT-3.048: NANT Urothelial Cancer Vaccine: Combination Immunotherapy in Subjects With Urothelial Cancer Who Have Progressed on or After Chemotherapy and PD-1/PD-L1 Therapy

Summary

This is a phase 1b/2 study to evaluate the safety and efficacy of metronomic combination therapy in subjects with urothelial cancer who have progressed on or after chemotherapy and anti- PD-1/PD-L1 therapy.

Conditions

• Urothelial Carcinoma

Interventions

BIOLOGICAL

avelumab

Fully human anti-PD-L1 IgG1 lambda monoclonal antibody

BIOLOGICAL

bevacizumab

Recombinant human anti-vascular endothelial growth factor (VEGF) IgG1 monoclonal antibody

DRUG

capecitabine

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

DRUG

cisplatin

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

DRUG

cyclophosphamide

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

DRUG

5Fluorouracil (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

DRUG

Lovaza

Omega-3-acid ethyl esters

RADIATION

Stereotactic Body Radiation Therapy

(SBRT)

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 (haNK™ for Infusion)

Sponsors & Collaborators

• ImmunityBio, Inc.

  lead INDUSTRY

Study Design

Allocation

NA

Purpose

TREATMENT

Masking

NONE

Model

SINGLE_GROUP

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2017-12-31

Primary Completion

2019-01-31

Completion

2021-12-28

FDA Drug

Yes