NCT03197584

QUILT-3.051: NANT Ovarian Cancer Vaccine: Combination Immunotherapy in Subjects With Epithelial Ovarian Cancer Who Have Progressed on or After Standard-of-care (SoC) Therapy

NANT Ovarian Cancer Vaccine: Combination Immunotherapy in Subjects With Epithelial Ovarian Cancer Who Have Progressed on or After Standard-of-care (SoC) 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• Status: Withdrawn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 epithelial ovarian cancer who have progressed on or after SoC 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. The maximum time on study treatment, including both the induction and maintenance phases, is 2 years.

Conditions

• Ovarian Cancer

Interventions

Type	Name	Description
BIOLOGICAL	Avelumab	Fully human anti-PD-L1 IgG1 lambda monoclonal antibody
BIOLOGICAL	Bevacizumab	Recombinant human anti-VEGF IgG1 monoclonal antibody
DRUG	Capecitabine	5'-deoxy-5-fluoro-N-\[(pentyloxy) carbonyl\]-cytidine
DRUG	Cyclophosphamide	2-\[bis(2-chloroethyl)amino\]tetrahydro-2H-1,3,2-oxazaphosphorine 2-oxide monohydrate
DRUG	5-fluorouracil	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	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	omega-3 acid ethyl esters	omega-3 acid ethyl esters
DRUG	Oxaliplatin	cis-\[(1 R,2 R)-1,2-cyclohexanediamine-N,N'\] \[oxalato(2-)- O,O'\] platinum
RADIATION	Stereotactic Body Radiation Therapy	Stereotactic Body Radiation Therapy (SBRT)
BIOLOGICAL	ALT-803	Recombinant human super agonist IL-15 complex
BIOLOGICAL	ETBX-021	Ad5 \[E1-, E2b-\]-HER2 vaccine
BIOLOGICAL	ETBX-051	Ad5 \[E1-, E2b-\]-Brachyury vaccine
BIOLOGICAL	ETBX-061	Ad5 \[E1-, E2b-\]-MUC1 vaccine
BIOLOGICAL	GI-4000	Heat-killed S. cerevisiae yeast expressing the mutated RAS oncoproteins
BIOLOGICAL	GI-6301	Heat-killed S. cerevisiae yeast expressing the human Brachyury (hBrachyury) oncoprotein
BIOLOGICAL	haNK®	NK-92 \[CD16.158V, ER IL-2\]

Timeline

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

Regulatory

• FDA-regulated drug study