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QUILT-3.080: NANT Pancreatic Cancer Vaccine

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03586869
Recruitment Status : Active, not recruiting
First Posted : July 16, 2018
Last Update Posted : July 16, 2019
Sponsor:
Information provided by (Responsible Party):
ImmunityBio, Inc.

Tracking Information
First Submitted Date  ICMJE June 22, 2018
First Posted Date  ICMJE July 16, 2018
Last Update Posted Date July 16, 2019
Actual Study Start Date  ICMJE July 28, 2018
Estimated Primary Completion Date December 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 20, 2018)
  • Incidence of treatment-emergent adverse events (AEs), graded using the NCI CTCAE Version 4.03 [ Time Frame: 2 years ]
    Phase 1b Primary Outcome
  • Incidence of treatment-emergent serious adverse events (SAEs), graded using the NCI CTCAE Version 4.03 [ Time Frame: 2 years ]
    Phase 1b Primary Outcome
  • Overall Response Rate by RECIST Version 1.1 [ Time Frame: 2 years ]
    Phase 2 Primary Outcome
Original Primary Outcome Measures  ICMJE
 (submitted: July 12, 2018)
  • Incidence of treatment-emergent AEs and SAEs, graded using the NCI CTCAE Version 4.03 [ Time Frame: 2 years ]
    Phase 1b
  • Overall Response Rate by RECIST Version 1.1. [ Time Frame: 2 years ]
    Phase 2 Primary Outcome
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: July 20, 2018)
ORR by RECIST Version 1.1 [ Time Frame: 2 years ]
Phase 1b Secondary Outcome
Original Secondary Outcome Measures  ICMJE
 (submitted: July 12, 2018)
Overall Response Rate by RECIST Version 1.1. [ Time Frame: 2 years ]
Phase 1b
Current Other Pre-specified Outcome Measures
 (submitted: July 20, 2018)
  • Overall Response Rate by immune-related Response Criteria (irRC) [ Time Frame: 2 years ]
    Phase 1b and 2 Secondary Outcome
  • Progression Free Survival by RECIST Version 1.1 [ Time Frame: 2 years ]
    Phase 1b and 2 Secondary Outcome
  • Progression Free Survival by irRC [ Time Frame: 2 years ]
    Phase 1b and 2 Secondary Outcome
  • Overall Survival [ Time Frame: 2 years ]
    Phase 1b and 2 Secondary Outcome
  • Duration Of Response by RECIST Version 1.1 and irRC [ Time Frame: 2 years ]
    Phase 1b and 2 Secondary Outcome
  • Disease Control Rate (confirmed CR, PR, or stable disease [SD] lasting for at least 2 months) by RECIST and irRC [ Time Frame: 2 years ]
    Phase 1b and 2 Secondary Outcome
  • Quality of Life by patient-reported outcomes (PROs) [ Time Frame: 2 years ]
    Phase 1b and 2 Secondary Outcome
Original Other Pre-specified Outcome Measures
 (submitted: July 12, 2018)
  • Overall Response Rate by irRC [ Time Frame: 2 years ]
    Phase 1b/2
  • Progression Free Survival by RECIST Version 1.1 [ Time Frame: 2 years ]
    Phase 1b/2
  • Progression Free Survival by irRC [ Time Frame: 2 years ]
    Phase 1b/2
  • Overall Survival [ Time Frame: 2 years ]
    Phase 1b/2
  • Duration Of Response by RECIST Version 1.1 and irRC [ Time Frame: 2 years ]
    Phase 1b/2
  • Disease Control Rate (confirmed CR, PR, or stable disease [SD] lasting for at least 2 months) by RECIST and irRC [ Time Frame: 2 years ]
    Phase 1b/2
  • Quality of Life by PROs [ Time Frame: 2 years ]
    Phase 1b/2
 
Descriptive Information
Brief Title  ICMJE QUILT-3.080: NANT Pancreatic Cancer Vaccine
Official Title  ICMJE QUILT-3.080: Phase 1B/2 Trial Of The NANT Pancreatic Cancer Vaccine As Treatment For Subjects With Pancreatic Cancer Who Have Progressed on or After Standard-Of-Care Therapy
Brief 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 Standard of Care (SoC) chemotherapy.
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 who experience ongoing stable disease (SD) or an ongoing partial response (PR) at 1 year 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 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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Phase 2
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Pancreatic Cancer
Intervention  ICMJE
  • Drug: Aldoxorubicin HCl
    Aldoxorubicin Hydrochloride
  • 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-]-HER2
  • Biological: ETBX-051
    Ad5 [E1-, E2b-]-Brachyury
  • Biological: ETBX-061
    Ad5 [E1-, E2b-]-MUC1
  • Biological: GI-4000
    RAS yeast
  • Biological: GI-6207
    Carcinoembryonic Antigen (CEA) yeast
  • Biological: GI-6301
    Brachyury yeast
  • Biological: haNK for infusion
    NK-92 [CD16.158V, ER IL-2]
  • Biological: bevacizumab
    Recombinant human anti-Vascular Endothelial Growth Factor (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: Oxaliplatin
    cis-[(1 R,2 R)-1,2-cyclohexanediamine-N,N'] [oxalato(2-)- O,O'] platinum
  • Biological: Avelumab
    Recombinant human anti-programmed death-ligand 1 (PD-L1) IgG1 monoclonal antibody
  • Procedure: SBRT
    Stereotactic Body Radiation Therapy
Study Arms  ICMJE Experimental: NANT Pancreatic Cancer Vaccine
A combination of agents will be administered to subjects in this study: Aldoxorubicin HCl, ALT-803, ETBX-011 (CEA), ETBX-021 (HER2), ETBX-051 (Brachyury), ETBX-061 (MUC1), GI-4000, GI-6207, GI-6301, haNK for infusion, avelumab, bevacizumab, capecitabine, cyclophosphamide, fluorouracil, leucovorin, nab-paclitaxel, oxaliplatin, and Stereotactic Body Radiation Therapy (SBRT).
Interventions:
  • 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 for infusion
  • Biological: bevacizumab
  • Drug: Capecitabine
  • Drug: Cyclophosphamide
  • Drug: Fluorouracil
  • Drug: Leucovorin
  • Drug: nab-Paclitaxel
  • Drug: Oxaliplatin
  • Biological: Avelumab
  • Procedure: SBRT
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Estimated Enrollment  ICMJE
 (submitted: July 12, 2018)
173
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 2019
Estimated Primary Completion Date December 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  1. Age ≥ 18 years old.
  2. Able to understand and provide a signed informed consent that fulfills the relevant IRB or Independent Ethics Committee (IEC) guidelines.
  3. Histologically-confirmed pancreatic adenocarcinoma with progression on or after SoC therapy.
  4. ECOG performance status of 0 to 2.
  5. Have at least 1 measurable lesion of ≥ 1.0 cm.
  6. Must have a recent formalin-fixed, paraffin-embedded (FFPE) tumor biopsy specimen following the conclusion of the most recent anticancer treatment and be willing to release the 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. If safety concerns preclude collection of a biopsy during the screening period, a tumor biopsy specimen collected prior to the conclusion of the most recent anticancer treatment may be used.
  7. Must be willing to provide blood samples prior to the start of treatment on this study for prospective tumor molecular profiling and exploratory analyses.
  8. 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.
  9. Ability to attend required study visits and return for adequate follow-up, as required by this protocol.
  10. 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, IUDs, and abstinence.

Exclusion Criteria:

  1. 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.
  2. Systemic autoimmune disease (eg, lupus erythematosus, rheumatoid arthritis, Addison's disease, autoimmune disease associated with lymphoma).
  3. History of organ transplant requiring immunosuppression.
  4. History of or active inflammatory bowel disease (eg, Crohn's disease, ulcerative colitis).
  5. Inadequate organ function, evidenced by the following laboratory results:

    1. Absolute neutrophil count < 1,000 cells/mm3.
    2. Platelet count < 75,000 cells/mm3.
    3. Total bilirubin greater than the upper limit of normal (ULN; unless the subject has documented Gilbert's syndrome).
    4. Aspartate aminotransferase (AST [SGOT]) or alanine aminotransferase (ALT [SGPT]) > 2.5 × ULN (> 5 × ULN in subjects with liver metastases).
    5. Alkaline phosphatase levels > 2.5 × ULN (> 5 × ULN in subjects with liver metastases, or >10 × ULN in subjects with bone metastases).
    6. Serum creatinine > 2.0 mg/dL or 177 μmol/L.
    7. Serum anion gap > 16 mEq/L or arterial blood with pH < 7.3.
    8. Medically uncorrectable grade 3 anemia (hemoglobin < 8 g/dL).
  6. 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.
  7. Serious myocardial dysfunction defined by ECHO as absolute left ventricular ejection fraction (LVEF) 10% below the institution's lower limit of predicted normal.
  8. Dyspnea at rest due to complications of advanced malignancy or other disease requiring continuous oxygen therapy.
  9. Positive results of screening test for human immunodeficiency virus (HIV).
  10. 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.
  11. Known hypersensitivity to any component of the study medication(s).
  12. Subjects taking any medication(s) (herbal or prescribed) known to have an adverse drug reaction with any of the study medications.
  13. 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.
  14. Concurrent or prior use of a strong CYP2C8 inhibitor (gemfibrozil) or moderate CYP2C8 inducer (rifampin) within 14 days before study day 1.
  15. Participation in an investigational drug study or history of receiving any investigational treatment within 14 days prior to initiation of treatment on this study, except for receipt of testosterone-lowering therapy in men with prostate cancer, or treatment with any NANT Cancer Vaccine therapy.
  16. Assessed by the Investigator to be unable or unwilling to comply with the requirements of the protocol.
  17. Concurrent participation in any interventional clinical trial.
  18. Pregnant and nursing women.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03586869
Other Study ID Numbers  ICMJE QUILT-3.080
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party ImmunityBio, Inc.
Study Sponsor  ICMJE ImmunityBio, Inc.
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account ImmunityBio, Inc.
Verification Date July 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP