NCT03563144

QUILT-3.088: NANT Pancreatic Cancer Vaccine

QUILT-3.088 NANT Pancreatic Cancer Vaccine: Phase II Randomized Trial of the NANT Pancreatic Cancer Vaccine vs. Standard-of-Care as First- Line Treatment for Patients With Metastatic Pancreatic Cancer

• Status: Withdrawn
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: ImmunityBio, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

QUILT-3.088 NANT Pancreatic Cancer Vaccine: Phase II Randomized Trial of the NANT Pancreatic Cancer Vaccine vs. Standard-of-Care as First- Line Treatment for Patients with Metastatic Pancreatic Cancer.

Detailed description

This is a two-cohort, open-label, randomized phase 2 study to evaluate the safety and efficacy (as assessed by PFS) of the NANT Pancreatic Cancer Vaccine regimen (experimental arms) vs SoC therapy (control arms) as first-line treatment for subjects with metastatic pancreatic cancer. Subjects will be enrolled into two independent cohorts based on ECOG status. Subjects with ECOG 0-1 will be randomized 1:1 to receive the NANT Pancreatic Cancer Vaccine regimen (experimental arm) or gemcitabine in combination with nab-paclitaxel (control arm), while subjects with ECOG 2 will be randomized 1:1 to receive the NANT Pancreatic Cancer Vaccine regimen (experimental arm) or gemcitabine monotherapy (control arm). The experimental arms will be administered in two phases, an induction and a subsequent maintenance phase. The treatment regimen administered in the experimental arms will be identical for all subjects, independent of ECOG status. Subjects may continue induction treatment for up to 1 year. Those who have a complete response (CR) in the induction phase will enter the maintenance phase of the study. Subjects who experience ongoing stable disease (SD) or an ongoing partial response (PR) after 1 year of induction phase treatment may enter the maintenance phase at the Investigator's discretion. Subjects may remain on the maintenance phase of the study for up to 1 year. Treatment in the study will be discontinued if the subject experiences confirmed PD or unacceptable toxicity, withdraws consent, or if the Investigator feels it is no longer in the subject's best interest to continue treatment. Subjects receiving treatment in the control arms may cross over to treatment in the induction phase of the experimental arms after experiencing PD. Subjects receiving treatment in the experimental arms with an initial assessment of PD per RECIST 1.1 may, at the discretion of the Investigator, continue to receive study treatment until PD is confirmed. The maximum time on study treatment is 2 years.

Conditions

• Metastatic Pancreatic Cancer

Interventions

Type	Name	Description
DRUG	Gemcitabine	Gemcitabine is a type of chemotherapy medication used to interfere with the cancer cells' ability to grow and divide.
DRUG	Nab-paclitaxel	NAB-paclitaxel is a type of chemotherapy called a microtubule inhibitor. Microtubule inhibitors interfere with a cancer cell's ability to grow and divide.
DRUG	Aldoxorubicin HCl	Albumin-binding prodrug of doxorubicin HCl
BIOLOGICAL	ALT-803	Recombinant human super agonist interleukin-15 (IL-15) complex
BIOLOGICAL	ETBX-011	Ad5 \[E1-, E2b-\]-CEA
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\[MUC1\]
BIOLOGICAL	GI-4000	Vaccine derived from recombinant Saccharomyces cerevisiae yeast expressing mutant Ras proteins
BIOLOGICAL	GI-6207	CEA yeast vaccine
BIOLOGICAL	GI-6301	Brachyury yeast vaccine
BIOLOGICAL	haNK	NK-92 \[CD16.158V, ER IL-2\]
DRUG	Avelumab	Avelumab
DRUG	Bevacizumab	Bevacizumab
DRUG	Capecitabine	Capecitabine
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	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	Oxaliplatin	Oxaliplatin

Timeline

• Start date: 2018-08-01
• Primary completion: 2019-12-30
• Completion: 2022-02-09
• First posted: 2018-06-20
• Last updated: 2025-02-21

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study