NCT03197571

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

QUILT-3.048: NANT Urothelial Cancer Vaccine: Combination Immunotherapy in Subjects With Urothelial Cancer 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• Status: Withdrawn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 urothelial cancer who have progressed on or after chemotherapy and anti- PD-1/PD-L1 therapy.

Detailed description

The initial 3 subjects will be enrolled in a staggered fashion, with a 21-day interval between each subject to enable the assessment of any acute and subacute toxicities, unless data are available from other NANT cancer vaccine studies suggesting the combination therapy is tolerable. Treatment will be administered in 2 phases, an induction and a maintenance phase, as described below. Subjects will continue induction treatment for up to 1 year. Treatment in the study will be discontinued if the subject experiences progressive disease (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. Those who have a complete response (CR) in the induction phase will enter the maintenance phase of the study. Subjects may remain on 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

• Urothelial 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) 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)

Timeline

• Start date: 2017-12-01
• Primary completion: 2019-01-01
• Completion: 2021-12-28
• First posted: 2017-06-23
• Last updated: 2025-02-21

Regulatory

• FDA-regulated drug study