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

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.

Conditions

• Ovarian Cancer

Interventions

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 \[CD16.158V, ER IL-2\]

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

2019-02-28

Completion

2021-12-28

FDA Drug

Yes