QUILT-3.090: NANT Squamous Cell Carcinoma (SCC) Vaccine: Subjects With SCC Who Have Progressed

Study Results

Results available

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Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE1/PHASE2

Total Enrollment

4 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-01-09

Study Completion Date

2021-01-11

Brief Summary

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This is a phase 1b/2 study to evaluate the safety and efficacy of metronomic combination therapy in subjects with SCC who have progressed on or after previous platinum-based chemotherapy and anti-PD-1/PD-L1 therapy. Phase 2 will be based on Simon's two-stage optimal design.

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Detailed Description

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Treatment will be administered in 2 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 and Sponsor's discretion. Subjects may remain in the maintenance phase of the study for up to 1 year. The duration of the maintenance phase can exceed 1 year if the subject continues to benefit, per the Investigator's and Sponsor's discretion. 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 time on study treatment, including both the induction and maintenance phases, is up to 2 years. The duration of the study may exceed 2 years if the subject remains in the maintenance phase for more than 1 year, as described above.

Conditions

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Squamous Cell Carcinoma

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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NANT Squamous Cell Carcinoma (SCC) Vaccine

Combination of agents were administered in this study: Aldoxorubicin HCl, ETBX-011, ETBX-021, ETBX-051, ETBX-061, GI-4000, GI-6207, GI-6301, haNK, N-803, avelumab, bevacizumab, capecitabine, cetuximab, cisplatin, cyclophosphamide, fluorouracil, leucovorin, nab-paclitaxel, necitumumab, SBRT.

Group Type EXPERIMENTAL

Aldoxorubicin HCl

Intervention Type DRUG

Aldoxorubicin hydrochloride

ETBX-011

Intervention Type BIOLOGICAL

Ad5 \[E1-, E2b-\]-CEA

ETBX-021

Intervention Type BIOLOGICAL

Ad5 \[E1-, E2b-\]-HER2

ETBX-051

Intervention Type BIOLOGICAL

Ad5 \[E1-, E2b-\]-Brachyury vaccine

ETBX-061

Intervention Type BIOLOGICAL

Ad5 \[E1-, E2b-\]-MUC1

GI-4000

Intervention Type BIOLOGICAL

Vaccine derived from recombinant Saccharomyces cerevisiae yeast expressing mutant Ras proteins

GI-6207

Intervention Type BIOLOGICAL

Vaccine derived from recombinant Saccharomyces cerevisiae yeast expressing mutant CEA proteins

GI-6301

Intervention Type BIOLOGICAL

Vaccine derived from recombinant Saccharomyces cerevisiae yeast expressing mutant Brachyury yeast proteins

haNK for infusion

Intervention Type BIOLOGICAL

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

Avelumab

Intervention Type DRUG

Recombinant human anti-PD-L1 IgG1 monoclonal antibody

bevacizumab

Intervention Type DRUG

Recombinant human anti-VEGF IgG1 monoclonal

Capecitabine

Intervention Type DRUG

5'-deoxy-5-fluoro-N-\[(pentyloxy) carbonyl\]-cytidine

Cetuximab

Intervention Type DRUG

Cetuximab is an epidermal growth factor receptor (EGFR) antagonist.

Cisplatin

Intervention Type DRUG

cis-diamminedichloroplatinum(II)

Cyclophosphamide

Intervention Type DRUG

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

Fluorouracil

Intervention Type DRUG

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

Leucovorin

Intervention Type DRUG

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

Intervention Type DRUG

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

Necitumumab

Intervention Type DRUG

Necitumumab is a recombinant human lgG1 monoclonal antibody.

SBRT

Intervention Type PROCEDURE

Stereotactic Body Radiation Therapy

N-803

Intervention Type BIOLOGICAL

Recombinant human superagonist interleukin-15 (IL-15) complex \[also known as IL-15N72D:IL-15RuSu/IgGI Fe complex1)

Interventions

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Aldoxorubicin HCl

Aldoxorubicin hydrochloride

Intervention Type DRUG

ETBX-011

Ad5 \[E1-, E2b-\]-CEA

Intervention Type BIOLOGICAL

ETBX-021

Ad5 \[E1-, E2b-\]-HER2

Intervention Type BIOLOGICAL

ETBX-051

Ad5 \[E1-, E2b-\]-Brachyury vaccine

Intervention Type BIOLOGICAL

ETBX-061

Ad5 \[E1-, E2b-\]-MUC1

Intervention Type BIOLOGICAL

GI-4000

Vaccine derived from recombinant Saccharomyces cerevisiae yeast expressing mutant Ras proteins

Intervention Type BIOLOGICAL

GI-6207

Vaccine derived from recombinant Saccharomyces cerevisiae yeast expressing mutant CEA proteins

Intervention Type BIOLOGICAL

GI-6301

Vaccine derived from recombinant Saccharomyces cerevisiae yeast expressing mutant Brachyury yeast proteins

Intervention Type BIOLOGICAL

haNK for infusion

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

Intervention Type BIOLOGICAL

Avelumab

Recombinant human anti-PD-L1 IgG1 monoclonal antibody

Intervention Type DRUG

bevacizumab

Recombinant human anti-VEGF IgG1 monoclonal

Intervention Type DRUG

Capecitabine

5'-deoxy-5-fluoro-N-\[(pentyloxy) carbonyl\]-cytidine

Intervention Type DRUG

Cetuximab

Cetuximab is an epidermal growth factor receptor (EGFR) antagonist.

Intervention Type DRUG

Cisplatin

cis-diamminedichloroplatinum(II)

Intervention Type DRUG

Cyclophosphamide

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

Intervention Type DRUG

Fluorouracil

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

Intervention Type 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

Intervention Type 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

Intervention Type DRUG

Necitumumab

Necitumumab is a recombinant human lgG1 monoclonal antibody.

Intervention Type DRUG

SBRT

Stereotactic Body Radiation Therapy

Intervention Type PROCEDURE

N-803

Recombinant human superagonist interleukin-15 (IL-15) complex \[also known as IL-15N72D:IL-15RuSu/IgGI Fe complex1)

Intervention Type BIOLOGICAL

Other Intervention Names

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Formerly known as ALT-803

Eligibility Criteria

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Inclusion Criteria

1. Age ≥ 18 years.
2. Able to understand and provide a signed informed consent that fulfills the relevant IRB or Independent Ethics Committee (IEC) guidelines.
3. Histologically-confirmed HNSCC or squamous NSCLC with progression on or after platinum-based chemotherapy and anti-PD-1/PD-L1 therapy.
4. Eastern Cooperative Oncology Group (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. 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. 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, or 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//mm\^3.
2. Uncorrectable grade 3 anemia (hemoglobin \< 8 g/dL).
3. Platelet count \< 75,000 cells/mm\^3.
4. Total bilirubin greater than the upper limit of normal (ULN; unless the subject has documented Gilbert's syndrome).
5. Aspartate aminotransferase (AST \[SGOT\]) or alanine aminotransferase (ALT \[SGPT\]) \> 2.5 × ULN (\> 5 × ULN in subjects with liver metastases).
6. Alkaline phosphatase levels \> 2.5 × ULN (\> 5 × ULN in subjects with liver metastases, or \>10 × ULN in subjects with bone metastases).
7. Serum creatinine \> 2.0 mg/dL or 177 μmol/L.
8. Serum anion gap \> 16 mEq/L or arterial blood with pH \< 7.3.
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 30 days prior to screening for this study, except for testosterone-lowering therapy in men with prostate cancer.
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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No