NCT03169777

QUILT-3.050: NANT Colorectal Cancer (CRC) Vaccine: Combination Immunotherapy in Subjects With Recurrent or Metastatic CRC

NANT Colorectal Cancer (CRC) Vaccine: Combination Immunotherapy in Subjects With Recurrent or Metastatic CRC

• Status: Withdrawn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 recurrent and metastatic CRC.

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 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 in 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

• Colorectal Cancer

Interventions

Type	Name	Description
BIOLOGICAL	avelumab	Fully human anti-programmed death-ligand 1 (PD-L1) immunoglobulin (Ig)G1 lambda monoclonal antibody
BIOLOGICAL	bevacizumab	Recombinant human anti-vascular endothelial growth factor (VEGF) IgG1 monoclonal antibody
DRUG	capecitabine	5'-deoxy-5-fluoro-N-\[(pentyloxy) carbonyl\]-cytidine
BIOLOGICAL	cetuximab	Recombinant human/mouse chimeric anti-epidermal growth factor receptor (EGFR) IgG1 monoclonal antibody
DRUG	Cyclophosphamide	2-\[bis(2-chloroethyl)amino\]tetrahydro-2H-1,3,2-oxazaphosphorine 2-oxide monohydrate
DRUG	5-Fluorouracil (5-FU)	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	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	Human anti-programmed cell death protein 1 (PD-1) IgG4 kappa monoclonal antibody
DRUG	Lovaza	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	(SBRT)
BIOLOGICAL	ALT-803	recombinant human super agonist interleukin-15 (IL-15) complex
BIOLOGICAL	ETBX-011	adenovirus serotype-5 \[Ad5\] \[E1-, E2b-\]-carcinoembryonic antigen \[CEA\] vaccine
BIOLOGICAL	ETBX-021	Ad5 \[E1-, E2b-\]-human epidermal growth factor receptor 2 \[HER2\] vaccine
BIOLOGICAL	ETBX-051	Ad5 \[E1-, E2b-\]-Brachyury vaccine
BIOLOGICAL	ETBX-061	Ad5 \[E1-, E2b-\]-mucin 1 \[MUC1\] vaccine
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

Timeline

• Start date: 2018-08-01
• Primary completion: 2019-01-01
• Completion: 2021-12-28
• First posted: 2017-05-30
• Last updated: 2025-02-21

Regulatory

• FDA-regulated drug study