QUILT-3.039: NANT Pancreatic Cancer Vaccine: Combination Immunotherapy in Subjects With Pancreatic Cancer Who Have Progressed on or After Standard-of-care Therapy
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|ClinicalTrials.gov Identifier: NCT03136406|
Recruitment Status : Unknown
Verified August 2020 by ImmunityBio, Inc..
Recruitment status was: Active, not recruiting
First Posted : May 2, 2017
Last Update Posted : August 12, 2020
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|Condition or disease||Intervention/treatment||Phase|
|Pancreatic Cancer||Drug: Cyclophosphamide Drug: Oxaliplatin Drug: Capecitabine Drug: 5-Fluorouracil Drug: Leucovorin Drug: nab-paclitaxel Biological: bevacizumab Biological: avelumab Biological: ALT-803 Biological: aNK for Infusion Biological: ETBX-011 Biological: GI-4000||Phase 1 Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||3 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||NANT Pancreatic Cancer Vaccine: Combination Immunotherapy in Subjects With Pancreatic Cancer Who Have Progressed on or After Standard-of-care Therapy|
|Actual Study Start Date :||August 14, 2017|
|Estimated Primary Completion Date :||December 2020|
|Estimated Study Completion Date :||April 2021|
Experimental: NANT Pancreatic Cancer Vaccine
A combination of agents will be administered to subjects in this study:
cyclophosphamide, oxaliplatin, capecitabine, fluorouracil, leucovorin, nab-paclitaxel, bevacizumab, avelumab, ALT-803, aNK, GI-4000, and ETBX-011.
2-[bis(2-chloroethyl)amino]tetrahydro-2H-1,3,2-oxazaphosphorine 2-oxide monohydrate
cis-[(1 R,2 R)-1,2-cyclohexanediamine-N,N'] [oxalato(2-)- O,O'] platinum
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
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
Recombinant human anti-VEGF IgG1 monoclonal
Recombinant human anti-PD-L1 IgG1 monoclonal antibody
Recombinant human super agonist interleukin-15 (IL-15) complex
Biological: aNK for Infusion
Ad5 [E1-, E2b-]-CEA
Vaccine derived from recombinant Saccharomyces cerevisiae yeast expressing mutant Ras proteins
- Incidence of treatment-emergent Adverse Events (AEs) and Serious Adverse Events (SAEs), graded using the NCI CTCAE Version 4.03. [ Time Frame: 8 weeks ]Phase 1b primary endpoint
- Objective response rate by RECIST [ Time Frame: 1 year ]Phase 2 primary endpoint
- Objective response rate by irRC [ Time Frame: 1 year ]Phase 2 primary endpoint
- Objective response rate by RECIST [ Time Frame: 8 weeks ]Phase 1b secondary endpoint
- Objective response rate by irRC [ Time Frame: 8 weeks ]Phase 1b secondary endpoint
- Progression-free survival by RECIST during Phase 1b [ Time Frame: 8 weeks ]Phase 1b secondary endpoint
- Progression-free survival by irRC during Phase 1b [ Time Frame: 8 weeks ]Phase 1b secondary endpoint
- Overall survival [ Time Frame: 8 weeks ]Phase 1b secondary endpoint
- Patient-reported outcomes of pancreatic cancer symptoms [ Time Frame: 8 weeks ]Phase 1b secondary endpoint
- Progression-free survival by RECIST during Phase 2 [ Time Frame: 1 year ]Phase 2 secondary endpoint
- Progression-free survival by irRC during Phase 2 [ Time Frame: 1 year ]Phase 2 secondary endpoint
- Overall survival [ Time Frame: 1 year ]Phase 2 secondary endpoint
- Duration of response [ Time Frame: 1 year ]Phase 2 secondary endpoint
- Disease control rate (confirmed complete response, partial response, or stable disease lasting for at least 2 months). [ Time Frame: 1 year ]Phase 2 secondary endpoint
- Patient-reported outcomes of pancreatic cancer symptoms [ Time Frame: 1 year ]Phase 2 secondary endpoint
- Incidence of treatment-emergent AEs, SAEs, graded using the NCI CTCAE Version 4.03. [ Time Frame: 1 year ]Phase 2 secondary endpoint
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
|Ages Eligible for Study:||18 Years and older (Adult, Older Adult)|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||No|
- Age ≥ 18 years old.
- Able to understand and provide a signed informed consent that fulfills the relevant IRB or IEC guidelines.
- Histologically-confirmed pancreatic cancer with progression on or after SoC therapy.
- ECOG performance status of 0 to 2.
- Have at least 1 measurable lesion and/or non-measurable disease evaluable according to RECIST Version 1.1.
- Must have a recent tumor biopsy specimen following the conclusion of the most recent anti-cancer treatment. If a historic specimen is not available, the subject must be willing to undergo a biopsy during the screening period.
- Must be willing to provide blood samples for exploratory analyses.
- 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 with child-bearing potential and non-sterile males.
- History of persistent grade 2 or higher (CTCAE Version 4.03) hematological toxicity resulting from previous therapy.
- History 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. Subjects with a history of another malignancy must have > 5 years without evidence of disease.
- 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).
- Requires whole blood transfusion to meet eligibility criteria.
Inadequate organ function, evidenced by the following laboratory results:
- White blood cell (WBC) count < 3,500 cells/mm3
- Absolute neutrophil count < 1,500 cells/mm3.
- Platelet count < 100,000 cells/mm3.
- Hemoglobin < 9 g/dL.
- 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 > 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.
- International normalized ratio (INR) or activated partial thromboplastin time (aPTT) or partial thromboplastin time (PTT) >1.5 × ULN (unless on therapeutic anti-coagulation).
- 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.
- 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), hepatitis B virus (HBV), or hepatitis C virus (HCV).
- 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. See Excluded Medications list.
- 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.
- 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03136406
|United States, California|
|Chan Soon-Shiong Institute for Medicine|
|El Segundo, California, United States, 90245|
|Responsible Party:||ImmunityBio, Inc.|
|Other Study ID Numbers:||
|First Posted:||May 2, 2017 Key Record Dates|
|Last Update Posted:||August 12, 2020|
|Last Verified:||August 2020|
|Individual Participant Data (IPD) Sharing Statement:|
|Plan to Share IPD:||No|
|Studies a U.S. FDA-regulated Drug Product:||Yes|
|Studies a U.S. FDA-regulated Device Product:||No|
Digestive System Neoplasms
Neoplasms by Site
Endocrine Gland Neoplasms
Digestive System Diseases
Endocrine System Diseases
Antineoplastic Agents, Phytogenic
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Antineoplastic Agents, Alkylating
Antineoplastic Agents, Immunological