QUILT-3.088: NANT Pancreatic Cancer Vaccine

NCT03563144 | Withdrawn Phase 2 DMC FDA Drug

• 1 other identifier: QUILT-3.088
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Metastatic Pancreatic Cancer

Outcome Measures

Primary Outcomes (1)

• Progression-Free Survival

  Compare the efficacy of the NANT Pancreatic Cancer Vaccine regimen vs standard-of-care (SoC) therapy as first-line treatment for patients with metastatic pancreatic cancer as assessed by progression-free survival (PFS) using RECIST Version 1.1

  12 mths

Secondary Outcomes (7)

• Overall Survival

  24 months

• Overall Response Rate

  19 months

• Duration of Response

  19 months

• Disease Control Rate

  19 months

• Quality of Life by Patient-Reported Outcomes

  19 months

Study Arms (3)

NANT Pancreatic Cancer Vaccine

EXPERIMENTAL

in subjects with ECOG=2 or subjects with ECOG=0 or 1 A combination of agents will be administered to subjects in this study: cyclophosphamide, bevacizumab, oxaliplatin, capecitabine, 5-fluorouracil, leucovorin, nab-paclitaxel, aldoxorubicin HCl, avelumab, ALT-803, haNK, GI-4000, GI-6207, GI-6301, ETBX-011, ETBX-021, ETBX-051, ETBX-061.

Drug: Nab-paclitaxel; Drug: Aldoxorubicin HCl; Biological: ALT-803; Biological: ETBX-011; Biological: ETBX-021; Biological: ETBX-051; Biological: ETBX-061; Biological: GI-4000; Biological: GI-6207; Biological: GI-6301; Biological: haNK; Drug: Avelumab; Drug: Bevacizumab; Drug: Capecitabine; Drug: Cyclophosphamide; Drug: 5-Fluorouracil; Drug: Leucovorin; Drug: Oxaliplatin

Gemcitabine and Nab-paclitaxel

ACTIVE COMPARATOR

Gemcitabine plus Nab-paclitaxel will be administered to subjects with ECOG=2

Drug: Gemcitabine; Drug: Nab-paclitaxel

Gemcitabine

ACTIVE COMPARATOR

Gemcitabine will be administered to subjects with ECOG=0 or 1

Drug: Gemcitabine

Interventions

Gemcitabine DRUG

Gemcitabine is a type of chemotherapy medication used to interfere with the cancer cells' ability to grow and divide.

Gemcitabine; Gemcitabine and Nab-paclitaxel

Nab-paclitaxel DRUG

NAB-paclitaxel is a type of chemotherapy called a microtubule inhibitor. Microtubule inhibitors interfere with a cancer cell's ability to grow and divide.

Gemcitabine and Nab-paclitaxel; NANT Pancreatic Cancer Vaccine

Aldoxorubicin HCl DRUG

Albumin-binding prodrug of doxorubicin HCl

NANT Pancreatic Cancer Vaccine

ALT-803 BIOLOGICAL

Recombinant human super agonist interleukin-15 (IL-15) complex

NANT Pancreatic Cancer Vaccine

ETBX-011 BIOLOGICAL

Ad5 \[E1-, E2b-\]-CEA

NANT Pancreatic Cancer Vaccine

ETBX-021 BIOLOGICAL

Ad5 \[E1-, E2b-\]-human epidermal growth factor receptor 2 \[HER2\] vaccine

NANT Pancreatic Cancer Vaccine

ETBX-051 BIOLOGICAL

Ad5 \[E1-, E2b-\]-Brachyury vaccine

NANT Pancreatic Cancer Vaccine

ETBX-061 BIOLOGICAL

Ad5 \[E1-, E2b-\]-mucin 1\[MUC1\]

NANT Pancreatic Cancer Vaccine

GI-4000 BIOLOGICAL

Vaccine derived from recombinant Saccharomyces cerevisiae yeast expressing mutant Ras proteins

NANT Pancreatic Cancer Vaccine

GI-6207 BIOLOGICAL

CEA yeast vaccine

NANT Pancreatic Cancer Vaccine

GI-6301 BIOLOGICAL

Brachyury yeast vaccine

NANT Pancreatic Cancer Vaccine

haNK BIOLOGICAL

NK-92 \[CD16.158V, ER IL-2\]

NANT Pancreatic Cancer Vaccine

Avelumab DRUG

Avelumab

NANT Pancreatic Cancer Vaccine

Bevacizumab DRUG

Bevacizumab

NANT Pancreatic Cancer Vaccine

Capecitabine DRUG

Capecitabine

NANT Pancreatic Cancer Vaccine

Cyclophosphamide DRUG

2-\[bis(2-chloroethyl)amino\]tetrahydro-2H-1,3,2-oxazaphosphorine 2-oxide monohydrate

NANT Pancreatic Cancer Vaccine

5-Fluorouracil DRUG

5-fluoro-2,4 (1H,3H)-pyrimidinedione

NANT Pancreatic Cancer Vaccine

Leucovorin DRUG

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

NANT Pancreatic Cancer Vaccine

Oxaliplatin DRUG

Oxaliplatin

NANT Pancreatic Cancer Vaccine

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age ≥ 18 years old.
• Able to understand and provide a signed informed consent that fulfills the relevant IRB or Independent Ethics Committee (IEC) guidelines.
• Histologically-confirmed metastatic pancreatic adenocarcinoma that has not been previously treated with chemotherapy.
• ECOG performance status of 0-2.
• Have at least 1 measurable lesion of ≥ 1.0 cm.
• If available, must be willing to release a recent formalin-fixed, paraffin-embedded (FFPE) tumor biopsy specimen for prospective and exploratory tumor molecular profiling. If an historic specimen is not available, the subject must be willing to undergo a biopsy during the screening period, if considered safe by the Investigator.
• Must be willing to provide blood samples prior to the start of treatment on this study for prospective tumor molecular profiling and exploratory analyses.
• Must be willing to provide a tumor biopsy specimen 8 weeks after the start of treatment for exploratory analyses, if considered safe by the Investigator.
• Ability to attend required study visits and return for adequate follow-up, as required by this protocol.
• Agreement to practice effective contraception for female subjects of child-bearing potential and non-sterile males. Female subjects of child-bearing potential must agree to use effective contraception for up to 1 year after completion of therapy, and non-sterile male subjects must agree to use a condom for up to 4 months after treatment. Effective contraception includes surgical sterilization (eg, vasectomy, tubal ligation), two forms of barrier methods (eg, condom, diaphragm) used with spermicide, intrauterine devices (IUDs), and abstinence.

You may not qualify if:

• Serious uncontrolled concomitant disease that would contraindicate the use of the investigational drug used in this study or that would put the subject at high risk for treatment-related complications.
• Systemic autoimmune disease (eg, lupus erythematosus, rheumatoid arthritis, Addison's disease, autoimmune disease associated with lymphoma).
• History of organ transplant requiring immunosuppression.
• History of or active inflammatory bowel disease (eg, Crohn's disease, ulcerative colitis).
• Inadequate organ function, evidenced by the following laboratory results:
• Absolute neutrophil count (ANC) \< 1,000 cells/mm\^3.
• Platelet count \< 75,000 cells/mm\^3.
• Total bilirubin greater than the upper limit of normal (ULN; unless the subject has documented Gilbert's syndrome).
• Aspartate aminotransferase (AST \[SGOT\]) or alanine aminotransferase (ALT \[SGPT\]) \> 2.5 × ULN (\> 5 × ULN in subjects with liver metastases).
• Alkaline phosphatase levels (ALP) \> 2.5 × ULN (\> 5 × ULN in subjects with liver metastases, or \>10 × ULN in subjects with bone metastases).
• Serum creatinine \> 2.0 mg/dL or 177 μmol/L.
• Serum anion gap \> 16 mEq/L or arterial blood with pH \< 7.3.
• Medically uncorrectable grade 3 anemia (hemoglobin \< 8 g/dL).
• Uncontrolled hypertension (systolic \> 160 mm Hg and/or diastolic \> 110 mm Hg) or clinically significant (ie, active) cardiovascular disease, cerebrovascular accident/stroke, or myocardial infarction within 6 months prior to first study medication; unstable angina; congestive heart failure of New York Heart Association grade 2 or higher; or serious cardiac arrhythmia requiring medication. Subjects with uncontrolled hypertension should be medically managed on a stable regimen to control hypertension prior to study entry.
• Serious myocardial dysfunction defined by echocardiogram (ECHO) as absolute left ventricular ejection fraction (LVEF) 10% below the institution's lower limit of predicted normal.

Sponsors & Collaborators

• ImmunityBio, Inc.: lead

Study Sites (1)

Chan Soon-Shiong Institute for Medicine

El Segundo, California, 90245, United States

Location

MeSH Terms

Conditions

Pancreatic Neoplasms

Interventions

Gemcitabine; 130-nm albumin-bound paclitaxel; ALT-803; yeast-CEA vaccine; avelumab; Bevacizumab; Capecitabine; Cyclophosphamide; Fluorouracil; Leucovorin; Oxaliplatin

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Endocrine Gland Neoplasms; Digestive System Diseases; Pancreatic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Heterocyclic Compounds; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins; Uracil; Pyrimidinones; Deoxyribonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides; Phosphoramide Mustards; Nitrogen Mustard Compounds; Mustard Compounds; Hydrocarbons, Halogenated; Hydrocarbons; Organic Chemicals; Phosphoramides; Organophosphorus Compounds; Formyltetrahydrofolates; Tetrahydrofolates; Folic Acid; Pterins; Pteridines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Coenzymes; Enzymes and Coenzymes; Coordination Complexes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: This is a randomized parallel group study comparing the NANT Pancreatic Cancer Vaccine and standard therapy with respect to efficacy and safety in treatment naïve patients with pancreatic cancer. Patients will be stratified by ECOG status and then randomized 1:1 to receive either the NANT Pancreatic Vaccine (n\~532) or standard therapy with gemcitabine alone (ECOG 2; n\~266) or combined with nab-paclitaxel (ECOG 0-1; n\~266). Treatment may continue for up to 2 years or until documented progression (RECIST v 1.1) or unacceptable toxicity. Patients on standard therapy who progress or experience unacceptable toxicity may crossover to receive NANT Pancreatic Vaccine.

Study Record Dates

• First Submitted: May 25, 2018
• First Posted: June 20, 2018
• Study Start: August 1, 2018
• Primary Completion: December 30, 2019
• Study Completion: February 9, 2022
• Last Updated: February 21, 2025

Record last verified: 2018-08

Locations

US (1)