QUILT-3.046: NANT Melanoma Vaccine: Combination Immunotherapy in Subjects With Melanoma 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 melanoma who have progressed on or after chemotherapy and anti-PD-1/PD-L1 therapy.

Conditions

• Melanoma

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

BIOLOGICAL

Nivolumab

Recombinant human anti-PD-1 IgG4 monoclonal antibody

DRUG

omega-3-acid ethyl esters

Omega-3-acid ethyl esters

RADIATION

Stereotactic Body Radiation Therapy

radiation

BIOLOGICAL

ALT-803

Recombinant human super agonist interleukin-15 (IL-15) complex

BIOLOGICAL

ETBX-011

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

BIOLOGICAL

ETBX-051

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

BIOLOGICAL

ETBX-061

Ad5 \[E1-, E2b-\]-MUC1

BIOLOGICAL

GI-6207

Heat-killed S. cerevisiae yeast expressing CEA

BIOLOGICAL

GI-6301

Heat-killed S. cerevisiae yeast expressing the human Brachyury (hBrachyury) oncoprotein

BIOLOGICAL

haNK

NK-92 \[CD16.158V, ER IL-2\] (high-affinity activated Natural Killer cells)

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