NCT03329248

QUILT-3.060: NANT Pancreatic Cancer Vaccine: Molecularly Informed Integrated Immunotherapy in Subjects With Pancreatic Cancer Who Have Progressed on or After Standard-of-care Therapy

NANT Pancreatic Cancer Vaccine: Molecularly Informed Integrated Immunotherapy Combining Innate High-affinity Natural Killer (haNK) Cell Therapy With Adaptive T-cell Therapy (Adenovirus, Yeast, Fusion Protein Vaccine) in Subjects With Pancreatic Cancer Who Have Progressed on or After Standard-of-care Therapy

• Status: Terminated
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 6 (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 pancreatic cancer who have progressed on or after previous SoC chemotherapy. Phase 2 will be based on Simon's two-stage optimal design.

Detailed description

Treatment will be administered in two phases, an induction and a maintenance phase, as described below. Subjects will continue induction treatment for up to 1 year. Treatment in the study will be discontinued if the subject experiences progressive disease (PD) or unacceptable toxicity (not corrected with dose reduction), withdraws 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 corrected 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 the induction and maintenance phases, is 2 years.

Conditions

• Pancreatic Cancer

Interventions

Type	Name	Description
BIOLOGICAL	ALT-803	Recombinant human super agonist interleukin-15 (IL-15) complex
BIOLOGICAL	ETBX-011	Ad5 \[E1-, E2b-\]-CEA
BIOLOGICAL	GI-4000	Vaccine derived from recombinant Saccharomyces cerevisiae yeast expressing mutant Ras proteins
BIOLOGICAL	haNK for infusion	NK-92 \[CD16.158V, ER IL-2\]
BIOLOGICAL	avelumab	Recombinant human anti-PD-L1 IgG1 monoclonal antibody
BIOLOGICAL	bevacizumab	Recombinant human anti-VEGF IgG1 monoclonal
DRUG	Capecitabine	5'-deoxy-5-fluoro-N-\[(pentyloxy) carbonyl\]-cytidine
DRUG	Cyclophosphamide	2-\[bis(2-chloroethyl)amino\]tetrahydro-2H-1,3,2-oxazaphosphorine 2-oxide monohydrate
DRUG	Fluorouracil	5-fluoro-2,4 (1H,3H)-pyrimidinedione
DRUG	Leucovorin	L-Glutamic acid, N-\[4-\[\[(2-amino-5-formyl-1,4,5,6,7,8-hexahydro-4-oxo-6-pteridinyl)methyl\]amino\]benzoyl\]-, calcium salt
DRUG	nab-Paclitaxel	Benzenepropanoic acid, β-(benzoylamino)-α-hydroxy-(2aR, 4S, 4aS, 6R, 9S, 11S, 12S, 12aR, 12bS)-6,12b-bis(acetyloxy)-12-(benzoyloxy)-2a, 3, 4, 4a, 5, 6, 9, 10, 11, 12, 12a, 12b-dodecahydro-4,11-dihydroxy-4a, 8, 13, 13-tetramethyl-5-oxo-7,11-methano-1H-cyclodeca\[3,4\]benz\[1,2-b\]oxet-9-y1ester,(αR,βS)-(9CI) bound to albumin
DRUG	lovaza	Omega-3-acid ethyl esters
DRUG	Oxaliplatin	cis-\[(1 R,2 R)-1,2-cyclohexanediamine-N,N'\] \[oxalato(2-)- O,O'\] platinum
PROCEDURE	SBRT	Stereotactic Body Radiation Therapy

Timeline

• Start date: 2017-11-06
• Primary completion: 2018-08-13
• Completion: 2019-11-01
• First posted: 2017-11-01
• Last updated: 2024-12-12
• Results posted: 2024-12-12

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study