NCT03167177

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

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• Status: Withdrawn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

Detailed description

Treatment will be administered in two phases. Subjects will continue treatment for up to 1 year or until they experience progressive disease (PD) or experience 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 phase 2 of the study. Subjects may remain on phase 2 of the study for up to 1 year. Treatment will continue in phase 2 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 phases, is up to 2 years.

Conditions

• Melanoma

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	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)

Timeline

• Start date: 2017-12-01
• Primary completion: 2019-01-01
• Completion: 2021-12-28
• First posted: 2017-05-25
• Last updated: 2025-02-21

Regulatory

• FDA-regulated drug study