Pancreatic Cancer
Conditions
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 SoC chemotherapy. Phase 2 will be based on Simon's two-stage optimal design.
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 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.
Interventions
DRUGLeucovorin
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
BIOLOGICALALT-803
Recombinant human super agonist interleukin-15 (IL-15) complex
BIOLOGICALETBX-011
Ad5 \[E1-, E2b-\]-CEA
BIOLOGICALGI-4000
Vaccine derived from recombinant Saccharomyces cerevisiae yeast expressing mutant Ras proteins
BIOLOGICALhaNK for infusion
NK-92 \[CD16.158V, ER IL-2\]
BIOLOGICALavelumab
Recombinant human anti-PD-L1 IgG1 monoclonal antibody
BIOLOGICALbevacizumab
Recombinant human anti-VEGF IgG1 monoclonal
DRUGCapecitabine
5'-deoxy-5-fluoro-N-\[(pentyloxy) carbonyl\]-cytidine
DRUGCyclophosphamide
2-\[bis(2-chloroethyl)amino\]tetrahydro-2H-1,3,2-oxazaphosphorine 2-oxide monohydrate
DRUGFluorouracil
5-fluoro-2,4 (1H,3H)-pyrimidinedione
DRUGnab-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
DRUGlovaza
Omega-3-acid ethyl esters
DRUGOxaliplatin
cis-\[(1 R,2 R)-1,2-cyclohexanediamine-N,N'\] \[oxalato(2-)- O,O'\] platinum
PROCEDURESBRT
Stereotactic Body Radiation Therapy
Sponsors
ImmunityBio, Inc.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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 cancer with progression on or after SoC therapy. 4. ECOG performance status of 0 to 2. 5. Have at least 1 measurable lesion of ≥ 1.5 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. 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. 8. Must be willing to provide a tumor biopsy specimen 8 weeks after the start of treatment, 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, intrauterine devices (IUDs), and abstinence.
Exclusion criteria
1. History of persistent grade 2 or higher (CTCAE Version 4.03) hematological toxicity resulting from previous therapy. 2. Within 5 years prior to first dose of study treatment, any evidence of other active malignancies or brain metastasis except controlled basal cell carcinoma; prior history of in situ cancer (eg, breast, melanoma, cervical); prior history of prostate cancer that is not under active systemic treatment (except hormonal therapy) and with undetectable prostate-specific antigen (PSA) (\< 0.2 ng/mL); bulky (≥ 1.5 cm) disease with metastasis in the central hilar area of the chest and involving the pulmonary vasculature. 3. 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. 4. Systemic autoimmune disease (eg, lupus erythematosus, rheumatoid arthritis, Addison's disease, autoimmune disease associated with lymphoma). 5. History of organ transplant requiring immunosuppression. 6. History of or active inflammatory bowel disease (eg, Crohn's disease, ulcerative colitis). 7. Requires whole blood transfusion to meet eligibility criteria. 8. Inadequate organ function, evidenced by the following laboratory results: 1. White blood cell (WBC) count \< 3,500 cells/mm3 2. Absolute neutrophil count \< 1,500 cells/mm3. 3. Platelet count \< 100,000 cells/mm3. 4. Hemoglobin \< 9 g/dL. 5. Total bilirubin greater than the upper limit of normal (ULN; unless the subject has documented Gilbert's syndrome). 6. Aspartate aminotransferase (AST \[SGOT\]) or alanine aminotransferase (ALT \[SGPT\]) \> 2.5 × ULN (\> 5 × ULN in subjects with liver metastases). 7. Alkaline phosphatase levels \> 2.5 × ULN (\> 5 × ULN in subjects with liver metastases, or \>10 × ULN in subjects with bone metastases). 8. Serum creatinine \> 2.0 mg/dL or 177 μmol/L. 9. Uncontrolled hypertension (systolic \> 150 mm Hg and/or diastolic \> 100 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. 10. Dyspnea at rest due to complications of advanced malignancy or other disease requiring continuous oxygen therapy. 11. Positive results of screening test for human immunodeficiency virus (HIV), hepatitis B virus (HBV), or hepatitis C virus (HCV). 12. 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. 13. Known hypersensitivity to any component of the study medication(s). 14. Subjects taking any medication(s) (herbal or prescribed) known to have an adverse drug reaction with any of the study medications. 15. 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. 16. Concurrent or prior use of a strong CYP2C8 inhibitor (gemfibrozil) or moderate CYP2C8 inducer (rifampin) within 14 days before study day 1. 17. Participation in an investigational drug study or history of receiving any investigational treatment within 14 days prior to screening for this study, except for testosterone-lowering therapy in men with prostate cancer. 18. Assessed by the Investigator to be unable or unwilling to comply with the requirements of the protocol. 19. Concurrent participation in any interventional clinical trial. 20. Pregnant and nursing women.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Treatment-emergent Adverse Events (AEs) and Serious AEs (SAEs) | 30 days after last dose, up to 2 years (up to 1 year in each treatment phase) or until they experience confirmed progressive disease or unacceptable toxicity, withdrawn consent, or if the Investigator feels it is no longer in their best interest. | Graded Using the National Cancer Institute(NCI) Common Terminology Criteria for Adverse Events (CTCAE) Version 4.03 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Objective Response Rate by irRC | Tumors will be assessed at screening, and tumor response will be assessed every 8 weeks during the induction phase, and every 12 weeks during the maintenance phase until confirmed disease progression, up to 211 days. | — |
| Progression Free Survival by RECIST Version 1.1. | Tumors will be assessed at screening, and tumor response will be assessed every 8 weeks during the induction phase, and every 12 weeks during the maintenance phase until disease progression or death | — |
| Progression Free Survival by irRC | Tumors will be assessed at screening, and tumor response will be assessed every 8 weeks during the induction phase, and every 12 weeks during the maintenance phase until confirmed disease progression or death | — |
| Overall Survival | Tumors will be assessed at screening, and tumor response will be assessed every 8 weeks during the induction phase, and every 12 weeks during the maintenance phase until death | — |
| Objective Response Rate by RECIST Version 1.1 | Tumors will be assessed at screening, and tumor response will be assessed every 8 weeks during the induction phase, and every 12 weeks during the maintenance phase until disease progression, up to 211 days. | — |
| Disease Control Rate (Confirmed Complete Response, Partial Response, or Stable Disease Lasting for at Least 2 Months) by RECIST Version 1.1. | Tumors were assessed at screening, and tumor response will be assessed every 8 weeks during the induction phase, and every 12 weeks during the maintenance phase until confirmed disease progression, up to 211 days | Disease control is defined as subjects with a confirmed CR, PR, or SD lasting for at least 2 months. |
| Quality of Life by Patient Reported Outcomes (PRO) | Up to 9 months | PROs were assessed using the Functional Assessment of Cancer Therapy-Hepatobiliary (FACT-Hep) questionnaire. The FACT-Hep is compilation of general questions divided into five QOL subscales: Physical Well-Being - Scores ranging from 0-28 Social/Family Well-Being - Scores ranging from 0-28 Emotional Well-Being - Scores ranging from 0-24 Functional Well-Being - Scores ranging from 0-28 Additional Concerns - Scores ranging from 0-72 It uses 5-point Likert-type response categories ranging from 0 = 'not at all' to 4 = 'very much'. The higher scales and subscales indicate better quality of life. Negatively worded items were reverse scored. If the missing for each subscale was less than 50%, the prorating scores were computed for the subscale. |
| Disease Control Rate (Confirmed Complete Response, Partial Response, or Stable Disease Lasting for at Least 2 Months) by irRC | Tumors were assessed at screening, and tumor response will be assessed every 8 weeks during the induction phase, and every 12 weeks during the maintenance phase until confirmed disease progression, up to 211 days | Disease control is defined as subjects with a confirmed CR, PR, or SD lasting for at least 2 months. |
| Duration of Response (DOR) by RECIST Version 1.1 and irRC | Tumors were assessed at screening, and tumor response will be assessed every 8 weeks during the induction phase, and every 12 weeks during the maintenance phase until confirmed disease progression, up to 211 days | DOR was be defined as the time from the date of first response (PR or CR) to the date of disease progression or death (any cause) whichever occurs first. Responding subjects completed study follow-up or initiating a new anticancer therapy prior to documented PD were censored in the DOR analysis at the last known date the subject was progression free prior completing follow-up or initiating the new therapy. |
Countries
United States
Participant flow
Pre-assignment details
Only the Phase 1b portion of the study enrolled participants. The study was terminated early, so no participants were enrolled on the Phase 2 portion of the study. Eligible participants could have gone through both induction and maintenance treatment on study.
Participants by arm
| Arm | Count |
|---|---|
| NANT Pancreatic Cancer Vaccine A combination of agents will be administered to subjects in this study: ALT-803, ETBX-011, GI-4000, haNK, avelumab, bevacizumab, capecitabine, cyclophosphamide, fluorouracil, leucovorin, nab-paclitaxel, omega-3-acid ethyl esters, oxaliplatin, SBRT ALT-803: Recombinant human super agonist interleukin-15 (IL-15) complex ETBX-011: Ad5 \[E1-, E2b-\]-CEA GI-4000: Vaccine derived from recombinant Saccharomyces cerevisiae yeast expressing mutant Ras proteins haNK for infusion: NK-92 \[CD16.158V, ER IL-2\] avelumab: Recombinant human anti-PD-L1 IgG1 monoclonal antibody bevacizumab: Recombinant human anti-VEGF IgG1 monoclonal Capecitabine: 5'-deoxy-5-fluoro-N-\[(pentyloxy) carbonyl\]-cytidine Cyclophosphamide: 2-\[bis(2-chloroethyl)amino\]tetrahydro-2H-1,3,2-oxazaphosphorine 2-oxide monohydrate Fluorouracil: 5-fluoro-2,4 (1H,3H)-pyrimidinedione 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 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 lovaza: Omega-3-acid ethyl esters Oxaliplatin: cis-\[(1 R,2 R)-1,2-cyclohexanediamine-N,N'\] \[oxalato(2-)- O,O'\] platinum SBRT: Stereotactic Body Radiation Therapy | 6 |
| Total | 6 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Progressive Disease | 6 |
Baseline characteristics
| Characteristic | NANT Pancreatic Cancer Vaccine |
|---|---|
| Age, Continuous | 51.8 years STANDARD_DEVIATION 9.02 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 5 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 1 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 1 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 5 Participants |
| Sex: Female, Male Female | 3 Participants |
| Sex: Female, Male Male | 3 Participants |
| Subjects with pancreatic cancer who have progressed on or after previous SoC chemotherapy | 6 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 6 / 6 |
| other Total, other adverse events | 6 / 6 |
| serious Total, serious adverse events | 3 / 6 |
Outcome results
Primary
Number of Participants With Treatment-emergent Adverse Events (AEs) and Serious AEs (SAEs)
Graded Using the National Cancer Institute(NCI) Common Terminology Criteria for Adverse Events (CTCAE) Version 4.03
Time frame: 30 days after last dose, up to 2 years (up to 1 year in each treatment phase) or until they experience confirmed progressive disease or unacceptable toxicity, withdrawn consent, or if the Investigator feels it is no longer in their best interest.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| NANT Pancreatic Cancer Vaccine | Number of Participants With Treatment-emergent Adverse Events (AEs) and Serious AEs (SAEs) | Treatment Emergent Serious Adverse Events | 3 Participants |
| NANT Pancreatic Cancer Vaccine | Number of Participants With Treatment-emergent Adverse Events (AEs) and Serious AEs (SAEs) | Treatment Emergent Adverse Events | 6 Participants |
Secondary
Disease Control Rate (Confirmed Complete Response, Partial Response, or Stable Disease Lasting for at Least 2 Months) by irRC
Disease control is defined as subjects with a confirmed CR, PR, or SD lasting for at least 2 months.
Time frame: Tumors were assessed at screening, and tumor response will be assessed every 8 weeks during the induction phase, and every 12 weeks during the maintenance phase until confirmed disease progression, up to 211 days
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| NANT Pancreatic Cancer Vaccine | Disease Control Rate (Confirmed Complete Response, Partial Response, or Stable Disease Lasting for at Least 2 Months) by irRC | Confirmed irCR | 0 Participants |
| NANT Pancreatic Cancer Vaccine | Disease Control Rate (Confirmed Complete Response, Partial Response, or Stable Disease Lasting for at Least 2 Months) by irRC | Confirmed irPR | 0 Participants |
| NANT Pancreatic Cancer Vaccine | Disease Control Rate (Confirmed Complete Response, Partial Response, or Stable Disease Lasting for at Least 2 Months) by irRC | Unconfirmed irCR | 0 Participants |
| NANT Pancreatic Cancer Vaccine | Disease Control Rate (Confirmed Complete Response, Partial Response, or Stable Disease Lasting for at Least 2 Months) by irRC | Unconfirmed irPR | 0 Participants |
| NANT Pancreatic Cancer Vaccine | Disease Control Rate (Confirmed Complete Response, Partial Response, or Stable Disease Lasting for at Least 2 Months) by irRC | irSD | 4 Participants |
| NANT Pancreatic Cancer Vaccine | Disease Control Rate (Confirmed Complete Response, Partial Response, or Stable Disease Lasting for at Least 2 Months) by irRC | Unconfirmed irPD | 0 Participants |
| NANT Pancreatic Cancer Vaccine | Disease Control Rate (Confirmed Complete Response, Partial Response, or Stable Disease Lasting for at Least 2 Months) by irRC | Confirmed irPD | 2 Participants |
Secondary
Disease Control Rate (Confirmed Complete Response, Partial Response, or Stable Disease Lasting for at Least 2 Months) by RECIST Version 1.1.
Disease control is defined as subjects with a confirmed CR, PR, or SD lasting for at least 2 months.
Time frame: Tumors were assessed at screening, and tumor response will be assessed every 8 weeks during the induction phase, and every 12 weeks during the maintenance phase until confirmed disease progression, up to 211 days
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| NANT Pancreatic Cancer Vaccine | Disease Control Rate (Confirmed Complete Response, Partial Response, or Stable Disease Lasting for at Least 2 Months) by RECIST Version 1.1. | Confirmed Complete Response | 0 Participants |
| NANT Pancreatic Cancer Vaccine | Disease Control Rate (Confirmed Complete Response, Partial Response, or Stable Disease Lasting for at Least 2 Months) by RECIST Version 1.1. | Confirmed Partial Response | 0 Participants |
| NANT Pancreatic Cancer Vaccine | Disease Control Rate (Confirmed Complete Response, Partial Response, or Stable Disease Lasting for at Least 2 Months) by RECIST Version 1.1. | Unconfirmed Complete Response | 0 Participants |
| NANT Pancreatic Cancer Vaccine | Disease Control Rate (Confirmed Complete Response, Partial Response, or Stable Disease Lasting for at Least 2 Months) by RECIST Version 1.1. | Unconfirmed Partial Response | 0 Participants |
| NANT Pancreatic Cancer Vaccine | Disease Control Rate (Confirmed Complete Response, Partial Response, or Stable Disease Lasting for at Least 2 Months) by RECIST Version 1.1. | Stable Disease | 5 Participants |
| NANT Pancreatic Cancer Vaccine | Disease Control Rate (Confirmed Complete Response, Partial Response, or Stable Disease Lasting for at Least 2 Months) by RECIST Version 1.1. | Progressive Disease | 1 Participants |
Secondary
Duration of Response (DOR) by RECIST Version 1.1 and irRC
DOR was be defined as the time from the date of first response (PR or CR) to the date of disease progression or death (any cause) whichever occurs first. Responding subjects completed study follow-up or initiating a new anticancer therapy prior to documented PD were censored in the DOR analysis at the last known date the subject was progression free prior completing follow-up or initiating the new therapy.
Time frame: Tumors were assessed at screening, and tumor response will be assessed every 8 weeks during the induction phase, and every 12 weeks during the maintenance phase until confirmed disease progression, up to 211 days
Population: There were no participants with confirmed CR or PR. Therefore, no participants were included in the DOR analysis.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| NANT Pancreatic Cancer Vaccine | Duration of Response (DOR) by RECIST Version 1.1 and irRC | NA Months |
Secondary
Objective Response Rate by irRC
Time frame: Tumors will be assessed at screening, and tumor response will be assessed every 8 weeks during the induction phase, and every 12 weeks during the maintenance phase until confirmed disease progression, up to 211 days.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| NANT Pancreatic Cancer Vaccine | Objective Response Rate by irRC | 0 Participants |
Secondary
Objective Response Rate by RECIST Version 1.1
Time frame: Tumors will be assessed at screening, and tumor response will be assessed every 8 weeks during the induction phase, and every 12 weeks during the maintenance phase until disease progression, up to 211 days.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| NANT Pancreatic Cancer Vaccine | Objective Response Rate by RECIST Version 1.1 | 0 Participants |
Secondary
Overall Survival
Time frame: Tumors will be assessed at screening, and tumor response will be assessed every 8 weeks during the induction phase, and every 12 weeks during the maintenance phase until death
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| NANT Pancreatic Cancer Vaccine | Overall Survival | 7.3 Months |
Secondary
Progression Free Survival by irRC
Time frame: Tumors will be assessed at screening, and tumor response will be assessed every 8 weeks during the induction phase, and every 12 weeks during the maintenance phase until confirmed disease progression or death
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| NANT Pancreatic Cancer Vaccine | Progression Free Survival by irRC | 4.8 Months |
Secondary
Progression Free Survival by RECIST Version 1.1.
Time frame: Tumors will be assessed at screening, and tumor response will be assessed every 8 weeks during the induction phase, and every 12 weeks during the maintenance phase until disease progression or death
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| NANT Pancreatic Cancer Vaccine | Progression Free Survival by RECIST Version 1.1. | 4.8 Months |
Secondary
Quality of Life by Patient Reported Outcomes (PRO)
PROs were assessed using the Functional Assessment of Cancer Therapy-Hepatobiliary (FACT-Hep) questionnaire. The FACT-Hep is compilation of general questions divided into five QOL subscales: Physical Well-Being - Scores ranging from 0-28 Social/Family Well-Being - Scores ranging from 0-28 Emotional Well-Being - Scores ranging from 0-24 Functional Well-Being - Scores ranging from 0-28 Additional Concerns - Scores ranging from 0-72 It uses 5-point Likert-type response categories ranging from 0 = 'not at all' to 4 = 'very much'. The higher scales and subscales indicate better quality of life. Negatively worded items were reverse scored. If the missing for each subscale was less than 50%, the prorating scores were computed for the subscale.
Time frame: Up to 9 months
Population: Not all participants had QOLs collected for analysis.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| NANT Pancreatic Cancer Vaccine | Quality of Life by Patient Reported Outcomes (PRO) | Additional Concerns - Baseline | 44.0 score on a scale |
| NANT Pancreatic Cancer Vaccine | Quality of Life by Patient Reported Outcomes (PRO) | Emotional Well-Being - Baseline | 14.0 score on a scale |
| NANT Pancreatic Cancer Vaccine | Quality of Life by Patient Reported Outcomes (PRO) | Functional Well-Being - Baseline | 19.0 score on a scale |
| NANT Pancreatic Cancer Vaccine | Quality of Life by Patient Reported Outcomes (PRO) | Physical Well-Being - Baseline | 16.0 score on a scale |
| NANT Pancreatic Cancer Vaccine | Quality of Life by Patient Reported Outcomes (PRO) | Social/Family Well-Being - Baseline | 25.0 score on a scale |
| NANT Pancreatic Cancer Vaccine | Quality of Life by Patient Reported Outcomes (PRO) | Additional Concerns - End of Dosing | 46.0 score on a scale |
| NANT Pancreatic Cancer Vaccine | Quality of Life by Patient Reported Outcomes (PRO) | Emotional Well-Being - End of Dosing | 12.5 score on a scale |
| NANT Pancreatic Cancer Vaccine | Quality of Life by Patient Reported Outcomes (PRO) | Functional Well-Being - End of Dosing | 13.0 score on a scale |
| NANT Pancreatic Cancer Vaccine | Quality of Life by Patient Reported Outcomes (PRO) | Physical Well-Being - End of Dosing | 15.0 score on a scale |
| NANT Pancreatic Cancer Vaccine | Quality of Life by Patient Reported Outcomes (PRO) | Social/Family Well-Being - End of Dosing | 22.6 score on a scale |