QUILT-3.049: NANT Triple Negative Breast Cancer (TNBC) Vaccine: Combination Immunotherapy in Subjects With TNBC Who Have Progressed on or After Anthracycline-based Chemotherapy

Summary

This is a phase 1b/2 study to evaluate the safety and efficacy of metronomic combination therapy in subjects with metastatic or unresectable TNBC who have progressed on or after anthracycline-based chemotherapy or who have refused anthracycline-based chemotherapy.

Conditions

• Triple Negative Breast 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

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-fluoro-2,4 (1H,3H)-pyrimidinedione

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

BIOLOGICAL

ETBX-011

adenovirus serotype-5 \[Ad5\] \[E1-, E2b-\]-CEA (carcinoembryonic antigen)

BIOLOGICAL

ETBX-051

Ad5 \[E1-, E2b-\]-Brachyury

BIOLOGICAL

ETBX-061

Ad5 \[E1-, E2b-\]-mucin 1 (MUC1)

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