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Metastatic Pancreatic CancerPhase 2NCT03563144

QUILT-3.088: NANT Pancreatic Cancer Vaccine

A Phase 2 study testing Gemcitabine, Nab-paclitaxel and Aldoxorubicin HCl in people with Metastatic Pancreatic Cancer, run by ImmunityBio, Inc. at 1 site in United States.

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Metastatic Pancreatic Cancer
What is being tested?
Gemcitabine, Nab-paclitaxel and Aldoxorubicin HCl
Type of treatment
Vaccines
Could I receive a placebo?
No, everyone receives an active treatment
How many people
0 participants
Where
1 siteUnited States
Study dates
Aug 2018to 9 Feb 2022
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.
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  • 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.

Who cannot join

  • 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.
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  • 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.
  • Dyspnea at rest due to complications of advanced malignancy or other disease requiring continuous oxygen therapy.
  • Positive results of screening test for human immunodeficiency virus (HIV).
  • Current chronic daily treatment (continuous for > 3 months) with systemic corticosteroids (dose equivalent to or greater than 10 mg/day methylprednisolone), excluding inhaled steroids. Short-term steroid use to prevent IV contrast allergic reaction or anaphylaxis in subjects who have known contrast allergies is allowed.
  • Known hypersensitivity to any component of the study medication(s).
  • Subjects taking any medication(s) (herbal or prescribed) known to have an adverse drug reaction with any of the study medications.
  • Concurrent or prior use of a strong cytochrome P450 (CYP)3A4 inhibitor (including ketoconazole, itraconazole, posaconazole, clarithromycin, indinavir, nefazodone, nelfinavir, ritonavir, saquinavir, telithromycin, voriconazole, and grapefruit products) or strong CYP3A4 inducers (including phenytoin, carbamazepine, rifampin, rifabutin, rifapentin, phenobarbital, and St John's Wort) within 14 days before study day 1.
  • Concurrent or prior use of a strong CYP2C8 inhibitor (gemfibrozil) or moderate CYP2C8 inducer (rifampin) within 14 days before study day 1.
  • History of receiving any investigational treatment for metastatic pancreatic cancer, or participation in an investigational drug study within 30 days prior to screening for this study, except for testosterone-lowering therapy in men with prostate cancer.
  • Assessed by the Investigator to be unable or unwilling to comply with the requirements of the protocol.
  • Concurrent participation in any interventional clinical trial.
  • Pregnant and nursing women.

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Chan Soon-Shiong Institute for Medicine

    El Segundo, California, 90245

Other trials in United States

About this study

Official title: 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

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.

Read the 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.

Being tested
Gemcitabine, Nab-paclitaxel, Aldoxorubicin HCl, ALT-803, ETBX-011
Medical subject headings
Pancreatic Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • GemcitabineDrug

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

  • Nab-paclitaxelDrug

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

  • Aldoxorubicin HClDrug

    Albumin-binding prodrug of doxorubicin HCl

  • ALT-803Biological

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

  • ETBX-011Biological

    Ad5 [E1-, E2b-]-CEA

  • ETBX-021Biological

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

  • ETBX-051Biological

    Ad5 [E1-, E2b-]-Brachyury vaccine

  • ETBX-061Biological

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

  • GI-4000Biological

    Vaccine derived from recombinant Saccharomyces cerevisiae yeast expressing mutant Ras proteins

  • GI-6207Biological

    CEA yeast vaccine

  • GI-6301Biological

    Brachyury yeast vaccine

  • haNKBiological

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

  • AvelumabDrug

    Avelumab

  • BevacizumabDrug

    Bevacizumab

  • CapecitabineDrug

    Capecitabine

  • CyclophosphamideDrug

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

  • 5-FluorouracilDrug

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

  • LeucovorinDrug

    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

  • OxaliplatinDrug

    Oxaliplatin

Study groups in NCT03563144
Study groupRoleWhat they receive
NANT Pancreatic Cancer VaccineExperimentalin 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.
Receives: 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-paclitaxelActive comparatorGemcitabine plus Nab-paclitaxel will be administered to subjects with ECOG=2
Receives: Drug: Gemcitabine; Drug: Nab-paclitaxel
GemcitabineActive comparatorGemcitabine will be administered to subjects with ECOG=0 or 1
Receives: Drug: Gemcitabine

What is being measured

The primary outcome is the main question the study is designed to answer.

  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

    Measured: 12 mths

Secondary outcomes (7)

  1. Overall Survival

    Overall Survival from first treatment to date of death (any cause)

    Measured: 24 months

  2. Overall Response Rate

    Overall Response Rate, as determined by the percentage of patients achieving Partial or Complete response per RECIST 1.1 and irRC

    Measured: 19 months

  3. Duration of Response

    Duration of Response from date of first response to date of disease progression or death (any cause), per RECIST 1.1 and irRC

    Measured: 19 months

  4. Disease Control Rate

    Disease Control Rate: the number of patients with a CR, PR or SD lasting at least 2 months per RECIST 1.1 and irRC

    Measured: 19 months

  5. Quality of Life by Patient-Reported Outcomes

    Quality of Life as assessed by Patient Reported Outcomes using the FACT-C questionnaire

    Measured: 19 months

  6. Progression Free Survival

    Progression Free Survival from baseline to progression per irRC

    Measured: 12 months

  7. Evaluation of safety as determined by incidence or treatment-emergent adverse events

    Incidence of treatment -emergent adverse events using NCI CTCAE Version 4.03

    Measured: 19 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted20 Jun 2018
  2. Study startAug 2018 (estimated)
  3. Primary completion30 Dec 2019 (estimated)
  4. Study completion9 Feb 2022

Why it stopped: Trial not initiated

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Single group
Model description
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.
Masking
None (open label)
Enrolment
0 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03563144
Sponsor's protocol ID
QUILT-3.088
Status last verified
Aug 2018
First submitted
25 May 2018
Last updated
21 Feb 2025
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Undecided

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Gemcitabine, Nab-paclitaxel and Aldoxorubicin HCl in people with Metastatic Pancreatic Cancer, run by ImmunityBio, Inc. at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 10 inclusion and 26 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: withdrawn, as of the sponsor's last update on 21 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study was withdrawn before enrolling participants, so there are no results.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Progression-Free Survival (time frame: 12 mths). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03563144.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Feb 2025.

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