QUILT-3.080: NANT Pancreatic Cancer Vaccine
- Conditions
- Pancreatic Cancer
- Registration Number
- NCT03586869
- Lead Sponsor
- ImmunityBio, Inc.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Terminated
- Sex
- All
- Target Recruitment
- 3
Inclusion Criteria:<br><br> 1. Age = 18 years old.<br><br> 2. Able to understand and provide a signed informed consent that fulfills the relevant<br> IRB or Independent Ethics Committee (IEC) guidelines.<br><br> 3. Histologically-confirmed pancreatic adenocarcinoma with progression on or after SoC<br> therapy.<br><br> 4. ECOG performance status of 0 to 2.<br><br> 5. Have at least 1 measurable lesion of = 1.0 cm.<br><br> 6. Must have a recent formalin-fixed, paraffin-embedded (FFPE) tumor biopsy specimen<br> following the conclusion of the most recent anticancer treatment and be willing to<br> release the specimen for prospective and exploratory tumor molecular profiling. If<br> an historic specimen is not available, the subject must be willing to undergo a<br> biopsy during the screening period, if considered safe by the Investigator. If<br> safety concerns preclude collection of a biopsy during the screening period, a tumor<br> biopsy specimen collected prior to the conclusion of the most recent anticancer<br> treatment may be used.<br><br> 7. Must be willing to provide blood samples prior to the start of treatment on this<br> study for prospective tumor molecular profiling and exploratory analyses.<br><br> 8. Must be willing to provide a tumor biopsy specimen 8 weeks after the start of<br> treatment for exploratory analyses, if considered safe by the Investigator.<br><br> 9. Ability to attend required study visits and return for adequate follow-up, as<br> required by this protocol.<br><br> 10. Agreement to practice effective contraception for female subjects of child-bearing<br> potential and non-sterile males. Female subjects of child-bearing potential must<br> agree to use effective contraception for up to 1 year after completion of therapy,<br> and non- sterile male subjects must agree to use a condom for up to 4 months after<br> treatment. Effective contraception includes surgical sterilization (eg, vasectomy,<br> tubal ligation), two forms of barrier methods (eg, condom, diaphragm) used with<br> spermicide, IUDs, and abstinence.<br><br>Exclusion Criteria:<br><br> 1. Serious uncontrolled concomitant disease that would contraindicate the use of the<br> investigational drug used in this study or that would put the subject at high risk<br> for treatment-related complications.<br><br> 2. Systemic autoimmune disease (eg, lupus erythematosus, rheumatoid arthritis,<br> Addison's disease, autoimmune disease associated with lymphoma).<br><br> 3. History of organ transplant requiring immunosuppression.<br><br> 4. History of or active inflammatory bowel disease (eg, Crohn's disease, ulcerative<br> colitis).<br><br> 5. Inadequate organ function, evidenced by the following laboratory results:<br><br> 1. Absolute neutrophil count < 1,000 cells/mm3.<br><br> 2. Platelet count < 75,000 cells/mm3.<br><br> 3. Total bilirubin greater than the upper limit of normal (ULN; unless the subject<br> has documented Gilbert's syndrome).<br><br> 4. Aspartate aminotransferase (AST [SGOT]) or alanine aminotransferase (ALT<br> [SGPT]) > 2.5 × ULN (> 5 × ULN in subjects with liver metastases).<br><br> 5. Alkaline phosphatase levels > 2.5 × ULN (> 5 × ULN in subjects with liver<br> metastases, or >10 × ULN in subjects with bone metastases).<br><br> 6. Serum creatinine > 2.0 mg/dL or 177 µmol/L.<br><br> 7. Serum anion gap > 16 mEq/L or arterial blood with pH < 7.3.<br><br> 8. Medically uncorrectable grade 3 anemia (hemoglobin < 8 g/dL).<br><br> 6. Uncontrolled hypertension (systolic > 160 mm Hg and/or diastolic > 110 mm Hg) or<br> clinically significant (ie, active) cardiovascular disease, cerebrovascular<br> accident/stroke, or myocardial infarction within 6 months prior to first study<br> medication; unstable angina; congestive heart failure of New York Heart Association<br> grade 2 or higher; or serious cardiac arrhythmia requiring medication. Subjects with<br> uncontrolled hypertension should be medically managed on a stable regimen to control<br> hypertension prior to study entry.<br><br> 7. Serious myocardial dysfunction defined by ECHO as absolute left ventricular ejection<br> fraction (LVEF) 10% below the institution's lower limit of predicted normal.<br><br> 8. Dyspnea at rest due to complications of advanced malignancy or other disease<br> requiring continuous oxygen therapy.<br><br> 9. Positive results of screening test for human immunodeficiency virus (HIV).<br><br> 10. Current chronic daily treatment (continuous for > 3 months) with systemic<br> corticosteroids (dose equivalent to or greater than 10 mg/day methylprednisolone),<br> excluding inhaled steroids. Short-term steroid use to prevent IV contrast allergic<br> reaction or anaphylaxis in subjects who have known contrast allergies is allowed.<br><br> 11. Known hypersensitivity to any component of the study medication(s).<br><br> 12. Subjects taking any medication(s) (herbal or prescribed) known to have an adverse<br> drug reaction with any of the study medications.<br><br> 13. Concurrent or prior use of a strong cytochrome P450 (CYP)3A4 inhibitor (including<br> ketoconazole, itraconazole, posaconazole, clarithromycin, indinavir, nefazodone,<br> nelfinavir, ritonavir, saquinavir, telithromycin, voriconazole, and grapefruit<br> products) or strong CYP3A4 inducers (including phenytoin, carbamazepine, rifampin,<br> rifabutin, rifapentin, phenobarbital, and St John's Wort) within 14 days before<br> study day 1.<br><br> 14. Concurrent or prior use of a strong CYP2C8 inhibitor (gemfibrozil) or moderate<br> CYP2C8 inducer (rifampin) within 14 days before study day 1.<br><br> 15. Participation in an investigational drug study or history of receiving any<br> investigational treatment within 14 days prior to initiation of treatment on this<br> study, except for receipt of testosterone-lowering therapy in men with prostate<br> cancer, or treatment with any NANT Cancer Vaccine therapy.<br><br> 16. Assessed by the Investigator to be unable or unwilling to comply with the<br> requirements of the protocol.<br><br> 17. Concurrent participation in any interventional clinical trial.<br><br> 18. Pregnant and nursing women.
Not provided
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Number of Participants With Treatment-emergent Adverse Events (AEs) and Serious AEs (SAEs)
- Secondary Outcome Measures
Name Time Method Objective Response Rate by RECIST Version 1.1;Objective Response Rate by irRC;Progression Free Survival by RECIST Version 1.1.;Progression Free Survival by irRC;Overall Survival;Duration of Response (DOR) by RECIST Version 1.1 and irRC;Disease Control Rate (Confirmed Complete Response, Partial Response, or Stable Disease Lasting for at Least 2 Months) by RECIST Version 1.1 and irRC;Quality of Life by Patient Reported Outcomes (PRO)