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

Part of paid clinical trials in El Segundo, California.

Sponsor
ImmunityBio, Inc.
Study ID
NCT03387111
Phase
PHASE1/PHASE2
Status
Terminated

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Aldoxorubicin HCl — DRUG
    Aldoxorubicin hydrochloride
  • ETBX-011 — BIOLOGICAL
    Ad5 \[E1-, E2b-\]-CEA
  • ETBX-021 — BIOLOGICAL
    Ad5 \[E1-, E2b-\]-HER2
  • ETBX-051 — BIOLOGICAL
    Ad5 \[E1-, E2b-\]-Brachyury vaccine
  • ETBX-061 — BIOLOGICAL
    Ad5 \[E1-, E2b-\]-MUC1
  • GI-4000 — BIOLOGICAL
    Vaccine derived from recombinant Saccharomyces cerevisiae yeast expressing mutant Ras proteins
  • GI-6207 — BIOLOGICAL
    Vaccine derived from recombinant Saccharomyces cerevisiae yeast expressing mutant CEA proteins
  • GI-6301 — BIOLOGICAL
    Vaccine derived from recombinant Saccharomyces cerevisiae yeast expressing mutant Brachyury yeast proteins
  • haNK for infusion — BIOLOGICAL
    NK-92 \[CD16.158V, ER IL-2\]
  • Avelumab — DRUG
    Recombinant human anti-PD-L1 IgG1 monoclonal antibody
  • bevacizumab — DRUG
    Recombinant human anti-VEGF IgG1 monoclonal
  • Capecitabine — DRUG
    5'-deoxy-5-fluoro-N-\[(pentyloxy) carbonyl\]-cytidine
  • Cetuximab — DRUG
    Cetuximab is an epidermal growth factor receptor (EGFR) antagonist.
  • Cisplatin — DRUG
    cis-diamminedichloroplatinum(II)
  • Cyclophosphamide — DRUG
    2-\[bis(2-chloroethyl)amino\]tetrahydro-2H-1,3,2-oxazaphosphorine 2-oxide monohydrate
  • Fluorouracil — DRUG
    5-fluoro-2,4 (1H,3H)-pyrimidinedione
  • Leucovorin — 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 — 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 — DRUG
    Necitumumab is a recombinant human lgG1 monoclonal antibody.
  • SBRT — PROCEDURE
    Stereotactic Body Radiation Therapy
  • N-803 — BIOLOGICAL
    Recombinant human superagonist interleukin-15 (IL-15) complex \[also known as IL-15N72D:IL-15RuSu/IgGI Fe complex1)

Study Details

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.

Key Dates

First listed
Dec 29, 2017
Start date
Jan 9, 2018
Status verified
Aug 2020
Primary completion
Apr 17, 2019
Completion
Jan 11, 2021

Study Design

Enrollment
4 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

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.

Primary Outcome Measure

Number of Participants With Treatment-emergent Adverse Events (AEs) and Serious AEs (SAEs) [ Time Frame: 30 days after last dose, up to 15.5 months ]

Locations (1)

FacilityCityStateZIPSite coordinators
Chan Soon-Shiong Institute for MedicineEl SegundoCalifornia90245-

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By research site
Chan Soon-Shiong Institute for Medicine· El Segundo, CA

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