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TerminatedNCT03387111Updated Aug 5, 2024Results posted

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

A Phase 1/2 interventional study of Aldoxorubicin HCl and ETBX-011 in Squamous Cell Carcinoma, sponsored by ImmunityBio, Inc.. Terminated at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-08-05.

Sponsored by ImmunityBio, Inc. · Phase 1/2, Interventional, and Treatment

Why this study was terminated
Study halted prematurely and will not resume; participants are no longer being examined or receiving intervention
Phase
Phase 1/2
Study type
Interventional
Enrollment
4
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

Study summary

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.

Read the detailed description

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.

02

Conditions studied

  • Squamous Cell Carcinoma
03

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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

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.
04

Study design

Phase
Phase 1 / Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
4 participants (actual)

Study arms

  • Experimental
    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.

    Drug: Aldoxorubicin HCl · 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 · Drug: Avelumab · Drug: bevacizumab · Drug: Capecitabine · Drug: Cetuximab · Drug: Cisplatin · Drug: Cyclophosphamide · Drug: Fluorouracil · Drug: Leucovorin · Drug: nab-Paclitaxel · Drug: Necitumumab · Procedure: SBRT · Biological: N-803

Interventions

  • DrugAldoxorubicin HCl

    Aldoxorubicin hydrochloride

  • BiologicalETBX-011

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

  • BiologicalETBX-021

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

  • BiologicalETBX-051

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

  • BiologicalETBX-061

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

  • BiologicalGI-4000

    Vaccine derived from recombinant Saccharomyces cerevisiae yeast expressing mutant Ras proteins

  • BiologicalGI-6207

    Vaccine derived from recombinant Saccharomyces cerevisiae yeast expressing mutant CEA proteins

  • BiologicalGI-6301

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

  • BiologicalhaNK for infusion

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

  • DrugAvelumab

    Recombinant human anti-PD-L1 IgG1 monoclonal antibody

  • Drugbevacizumab

    Recombinant human anti-VEGF IgG1 monoclonal

  • DrugCapecitabine

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

  • DrugCetuximab

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

  • DrugCisplatin

    cis-diamminedichloroplatinum(II)

  • DrugCyclophosphamide

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

  • DrugFluorouracil

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

  • 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

  • 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

  • DrugNecitumumab

    Necitumumab is a recombinant human lgG1 monoclonal antibody.

  • ProcedureSBRT

    Stereotactic Body Radiation Therapy

  • BiologicalN-803

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

    Also known as: Formerly known as ALT-803

05

What researchers measure

Primary outcomes

  1. 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 15.5 months

Secondary outcomes

  1. Objective Response Rate 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 by computed tomography (CT) or magnetic resonance imaging (MRI) of target and non-target lesions in accordance with RECIST Version 1.1. An objective response is defined as a confirmed complete or partial overall response with confirmation occurring at least 4 weeks after the initial response is observed.

    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 disease progression, up to 11 months.

  2. Objective Response Rate 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 by computed tomography (CT) or magnetic resonance imaging (MRI) of target and non-target lesions in accordance with immune-related response criteria (irRC). An objective response is defined as a confirmed complete or partial overall response with confirmation occurring at least 4 weeks after the initial response is observed.

    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 11 months.

  3. Progression Free Survival by RECIST Version 1.1.

    Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions PFS was evaluated using Kaplan-Meier methods. PFS was defined as the time from the date of first treatment to the date of disease progression or death (any cause) whichever occurs first. Subjects completing study follow-up or initiating a new anticancer therapy prior to documented PD was censored in the PFS analysis at the last known date the subject was progression free prior to completing follow-up or initiating the new therapy.

    Time frame: Tumors were assessed at screening, and tumor response was assessed every 8 weeks during the induction phase, and every 12 weeks during the maintenance phase until disease progression or death (any cause) whichever occurred first, up to 11 months.

  4. Progression Free Survival by irRC

    PFS was evaluated using Kaplan-Meier methods. PFS was defined as the time from the date of first treatment to the date of disease progression or death (any cause) whichever occurs first. Subjects completing study follow-up or initiating a new anticancer therapy prior to documented PD was censored in the PFS analysis at the last known date the subject was progression free prior to completing follow-up or initiating the new therapy.

    Time frame: Tumors were assessed at screening, and tumor response was assessed every 8 weeks during the induction phase, and every 12 weeks during the maintenance phase until disease progression or death (any cause) whichever occurred first, up to 11 months.

  5. Overall Survival

    OS was evaluated using Kaplan-Meier methods. OS was defined as the time from the date of first treatment to the date of death (any cause). Participants who were alive at the end of follow-up were censored in the OS analysis at the last known date alive.

    Time frame: Participants were assessed from screening to death.

  6. Duration of Response (DOR) by RECIST Version 1.1 and irRC

    DOR was defined as the time from the date of first response (PR or CR) to the date of disease progression or death (any cause) whichever occurred first. Responding subjects completed study follow-up or initiated a new anticancer therapy prior to documented PD was 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 was assessed every 8 weeks during the induction phase, and every 12 weeks during the maintenance phase until disease progression or death (any cause) whichever occurred first, up to 11 months.

  7. 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: Up to 11 months

  8. Quality of Life (QoL) by Patient Reported Outcomes

    QoL was conducted via PROs using the Functional Assessment of Cancer Therapy - Head and Neck (FACT-H\&N) or Functional Assessment of Cancer Therapy - Lung (FACT-L) questionnaire. The FACT-H\&N and FACT-L compilation of general questions divided into five QoL subscales: Physical Well-Being, Social/Family Well-Being, Emotional Well-Being, Functional Well-Being, and Additional Concerns. It uses 5-point Likert-type response categories ranging from 0 = 'not at all' to 4 = 'very much'. Each subscale consists of 6-12 questions to answer.

    Time frame: Up to 15.5 months

  9. 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: Up to 11 months

06

Results

Posted Aug 5, 2024

Participant flow

Participant flow — Overall Study
MilestoneNANT Squamous Cell Carcinoma (SCC) Vaccine
Started4
Completed0
Not completed4
Withdrew: Progressive disease3
Withdrew: Other1

Outcome measures

PrimaryNumber 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 15.5 months
Reported as:
Count of participants · Participants
Number of Participants With Treatment-emergent Adverse Events (AEs) and Serious AEs (SAEs)
ParticipantsNANT Squamous Cell Carcinoma (SCC) Vaccine
Number of Participants With Treatment-emergent Adverse Events (AEs) and Serious AEs (SAEs)4
SecondaryObjective Response Rate 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 by computed tomography (CT) or magnetic resonance imaging (MRI) of target and non-target lesions in accordance with RECIST Version 1.1. An objective response is defined as a confirmed complete or partial overall response with confirmation occurring at least 4 weeks after the initial response is observed.

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 disease progression, up to 11 months.
Reported as:
Count of participants · Participants
Objective Response Rate by RECIST Version 1.1
ParticipantsNANT Squamous Cell Carcinoma (SCC) Vaccine
Objective Response Rate by RECIST Version 1.10
SecondaryObjective Response Rate 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 by computed tomography (CT) or magnetic resonance imaging (MRI) of target and non-target lesions in accordance with immune-related response criteria (irRC). An objective response is defined as a confirmed complete or partial overall response with confirmation occurring at least 4 weeks after the initial response is observed.

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 11 months.
Reported as:
Count of participants · Participants
Objective Response Rate by irRC
ParticipantsNANT Squamous Cell Carcinoma (SCC) Vaccine
Objective Response Rate by irRC0
SecondaryProgression Free Survival by RECIST Version 1.1.

Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions PFS was evaluated using Kaplan-Meier methods. PFS was defined as the time from the date of first treatment to the date of disease progression or death (any cause) whichever occurs first. Subjects completing study follow-up or initiating a new anticancer therapy prior to documented PD was censored in the PFS analysis at the last known date the subject was progression free prior to completing follow-up or initiating the new therapy.

Time frame:
Tumors were assessed at screening, and tumor response was assessed every 8 weeks during the induction phase, and every 12 weeks during the maintenance phase until disease progression or death (any cause) whichever occurred first, up to 11 months.
Reported as:
Median · Months
Progression Free Survival by RECIST Version 1.1.
MonthsNANT Squamous Cell Carcinoma (SCC) Vaccine
Progression Free Survival by RECIST Version 1.1.5.3 (0.8 to NA)
SecondaryProgression Free Survival by irRC

PFS was evaluated using Kaplan-Meier methods. PFS was defined as the time from the date of first treatment to the date of disease progression or death (any cause) whichever occurs first. Subjects completing study follow-up or initiating a new anticancer therapy prior to documented PD was censored in the PFS analysis at the last known date the subject was progression free prior to completing follow-up or initiating the new therapy.

Time frame:
Tumors were assessed at screening, and tumor response was assessed every 8 weeks during the induction phase, and every 12 weeks during the maintenance phase until disease progression or death (any cause) whichever occurred first, up to 11 months.
Reported as:
Median · Months
Progression Free Survival by irRC
MonthsNANT Squamous Cell Carcinoma (SCC) Vaccine
Progression Free Survival by irRC5.7 (4.9 to NA)
SecondaryOverall Survival

OS was evaluated using Kaplan-Meier methods. OS was defined as the time from the date of first treatment to the date of death (any cause). Participants who were alive at the end of follow-up were censored in the OS analysis at the last known date alive.

Time frame:
Participants were assessed from screening to death.
Reported as:
Median · Months
Overall Survival
MonthsNANT Squamous Cell Carcinoma (SCC) Vaccine
Overall Survival15.1 (6.4 to NA)
SecondaryDuration of Response (DOR) by RECIST Version 1.1 and irRC

DOR was defined as the time from the date of first response (PR or CR) to the date of disease progression or death (any cause) whichever occurred first. Responding subjects completed study follow-up or initiated a new anticancer therapy prior to documented PD was 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 was assessed every 8 weeks during the induction phase, and every 12 weeks during the maintenance phase until disease progression or death (any cause) whichever occurred first, up to 11 months.
Reported as:
Count of participants · Participants
Duration of Response (DOR) by RECIST Version 1.1 and irRC
ParticipantsNANT Squamous Cell Carcinoma (SCC) Vaccine
Duration of Response (DOR) by RECIST Version 1.1 and irRC0
SecondaryDisease 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:
Up to 11 months
Reported as:
Count of participants · Participants
Disease Control Rate (Confirmed Complete Response, Partial Response, or Stable Disease Lasting for at Least 2 Months) by RECIST Version 1.1
ParticipantsNANT Squamous Cell Carcinoma (SCC) Vaccine
Confirmed Complete Response0
Confirmed Partial Response0
Unconfirmed Complete Response0
Unconfirmed Partial Response1
Stable Disease1
Progressive Disease1
Imaging Not Available to Evaluate1
SecondaryQuality of Life (QoL) by Patient Reported Outcomes

QoL was conducted via PROs using the Functional Assessment of Cancer Therapy - Head and Neck (FACT-H\&N) or Functional Assessment of Cancer Therapy - Lung (FACT-L) questionnaire. The FACT-H\&N and FACT-L compilation of general questions divided into five QoL subscales: Physical Well-Being, Social/Family Well-Being, Emotional Well-Being, Functional Well-Being, and Additional Concerns. It uses 5-point Likert-type response categories ranging from 0 = 'not at all' to 4 = 'very much'. Each subscale consists of 6-12 questions to answer.

Time frame:
Up to 15.5 months

No measurements were reported for this outcome.

SecondaryDisease 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:
Up to 11 months
Reported as:
Count of participants · Participants
Disease Control Rate (Confirmed Complete Response, Partial Response, or Stable Disease Lasting for at Least 2 Months) by irRC
ParticipantsNANT Squamous Cell Carcinoma (SCC) Vaccine
Confirmed irCR0
Confirmed irPR0
Unconfirmed irCR0
Unconfirmed irPR1
irSD2
Unconfirmed irPD0
Confirmed irPD0
Imaging not available to evaluate1

Adverse events

Collected over Non-serious AEs were followed for 30 days after the subject's last dose of study treatment, up to 15.5 months. Non-serious grade 3 or 4 AEs were followed until resolution or stabilization, up to 15.5 months. All SAEs that had not resolved upon discontinuation of the subject's participation in the study were followed until recovered, recovered with sequelae, not recovered (death due to other cause), death (due to the SAE), lost to follow-up.. Non-serious events are listed at a 5% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
NANT Squamous Cell Carcinoma (SCC) Vaccine4/4 (100%)2/4 (50%)4/4 (100%)
Most frequent serious events
Most frequent serious events
EventNANT Squamous Cell Carcinoma (SCC) Vaccine
Febrile neutropeniaBlood and lymphatic system disorders1/4
Mouth haemorrhageGastrointestinal disorders1/4
PyrexiaGeneral disorders1/4
AbscessInfections and infestations1/4
SepsisInfections and infestations1/4
Staphylococcal bacteraemiaInfections and infestations1/4
Wound infectionInfections and infestations1/4
Muscular weaknessMusculoskeletal and connective tissue disorders1/4
Cerebral venous sinus thrombosisNervous system disorders1/4
HaemorrhageVascular disorders1/4
Most frequent other events
Showing 10 of 80
Most frequent other events
EventNANT Squamous Cell Carcinoma (SCC) Vaccine
FatigueGeneral disorders4/4
PyrexiaGeneral disorders4/4
AnaemiaBlood and lymphatic system disorders3/4
NauseaGastrointestinal disorders3/4
ChillsGeneral disorders3/4
Injection site reactionGeneral disorders3/4
Weight decreasedInvestigations3/4
HypomagnesaemiaMetabolism and nutrition disorders3/4
Febrile neutropeniaBlood and lymphatic system disorders2/4
NeutropeniaBlood and lymphatic system disorders2/4

Baseline characteristics

Age, Continuous
Age, Continuous(years)NANT Squamous Cell Carcinoma (SCC) Vaccine
Mean63.5 ± 10.91
Sex: Female, Male
Sex: Female, Male(Participants)NANT Squamous Cell Carcinoma (SCC) Vaccine
Female0
Male4
Ethnicity (NIH/OMB)
Ethnicity (NIH/OMB)(Participants)NANT Squamous Cell Carcinoma (SCC) Vaccine
Hispanic or Latino0
Not Hispanic or Latino2
Unknown or Not Reported2
Race (NIH/OMB)
Race (NIH/OMB)(Participants)NANT Squamous Cell Carcinoma (SCC) Vaccine
American Indian or Alaska Native0
Asian0
Native Hawaiian or Other Pacific Islander0
Black or African American0
White3
More than one race0
Unknown or Not Reported1
Subjects with SCC who have progressed
Subjects with SCC who have progressed(Participants)NANT Squamous Cell Carcinoma (SCC) Vaccine
Count of participants4
07

Study locations

1 site
  • Chan Soon-Shiong Institute for Medicine
    El Segundo, California 90245, United States
08

References and documents

Study documents

  • Protocol and statistical analysis plan · Oct 3, 2018

Documents are hosted by the registry — open the source record to download them.

09

Registry details

Key details

Study ID
NCT03387111
Lead sponsor
ImmunityBio, Inc.
Responsible party
Sponsor
First posted
Dec 29, 2017
Start date
Jan 9, 2018
Primary completion
Apr 17, 2019
Completion
Jan 11, 2021
Results posted
Aug 5, 2024
Last update
Aug 5, 2024

Oversight

Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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