NCT03175666

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

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

• Status: Withdrawn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 metastatic or unresectable TNBC who have progressed on or after anthracycline-based chemotherapy or who have refused anthracycline-based chemotherapy.

Detailed description

Treatment will be administered in 2 phases, an induction and a maintenance phase, as described below. Subjects will continue induction 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 the maintenance phase of the study. Subjects may remain on 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.

Conditions

• Triple Negative Breast 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	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)

Timeline

• Start date: 2017-12-01
• Primary completion: 2019-01-01
• Completion: 2021-12-28
• First posted: 2017-06-05
• Last updated: 2025-02-21

Regulatory

• FDA-regulated drug study