QUILT-3.088: NANT Pancreatic Cancer Vaccine

Part of paid clinical trials in El Segundo, California.

Sponsor
ImmunityBio, Inc.
Study ID
NCT03563144
Phase
PHASE2
Status
Withdrawn

Conditions

  • Metastatic Pancreatic Cancer

Eligibility Criteria

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

Interventions

  • Gemcitabine — DRUG
    Gemcitabine is a type of chemotherapy medication used to interfere with the cancer cells' ability to grow and divide.
  • Nab-paclitaxel — DRUG
    NAB-paclitaxel is a type of chemotherapy called a microtubule inhibitor. Microtubule inhibitors interfere with a cancer cell's ability to grow and divide.
  • Aldoxorubicin HCl — DRUG
    Albumin-binding prodrug of doxorubicin HCl
  • ALT-803 — BIOLOGICAL
    Recombinant human super agonist interleukin-15 (IL-15) complex
  • ETBX-011 — BIOLOGICAL
    Ad5 \[E1-, E2b-\]-CEA
  • ETBX-021 — BIOLOGICAL
    Ad5 \[E1-, E2b-\]-human epidermal growth factor receptor 2 \[HER2\] vaccine
  • ETBX-051 — BIOLOGICAL
    Ad5 \[E1-, E2b-\]-Brachyury vaccine
  • ETBX-061 — BIOLOGICAL
    Ad5 \[E1-, E2b-\]-mucin 1\[MUC1\]
  • GI-4000 — BIOLOGICAL
    Vaccine derived from recombinant Saccharomyces cerevisiae yeast expressing mutant Ras proteins
  • GI-6207 — BIOLOGICAL
    CEA yeast vaccine
  • GI-6301 — BIOLOGICAL
    Brachyury yeast vaccine
  • haNK — BIOLOGICAL
    NK-92 \[CD16.158V, ER IL-2\]
  • Avelumab — DRUG
    Avelumab
  • Bevacizumab — DRUG
    Bevacizumab
  • Capecitabine — DRUG
    Capecitabine
  • Cyclophosphamide — DRUG
    2-\[bis(2-chloroethyl)amino\]tetrahydro-2H-1,3,2-oxazaphosphorine 2-oxide monohydrate
  • 5-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
  • Oxaliplatin — DRUG
    Oxaliplatin

Study Details

QUILT-3.088 NANT Pancreatic Cancer Vaccine: Phase II Randomized Trial of the NANT Pancreatic Cancer Vaccine vs. Standard-of-Care as First- Line Treatment for Patients with Metastatic Pancreatic Cancer.

Key Dates

First listed
Jun 20, 2018
Start date
Aug 31, 2018
Status verified
Aug 2018
Primary completion
Dec 30, 2019
Completion
Feb 9, 2022

Study Design

Enrollment
0 participants (actual)
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: NANT Pancreatic Cancer Vaccine
    in subjects with ECOG=2 or subjects with ECOG=0 or 1 A combination of agents will be administered to subjects in this study: cyclophosphamide, bevacizumab, oxaliplatin, capecitabine, 5-fluorouracil, leucovorin, nab-paclitaxel, aldoxorubicin HCl, avelumab, ALT-803, haNK, GI-4000, GI-6207, GI-6301, ETBX-011, ETBX-021, ETBX-051, ETBX-061.
  • Active Comparator: Gemcitabine and Nab-paclitaxel
    Gemcitabine plus Nab-paclitaxel will be administered to subjects with ECOG=2
  • Active Comparator: Gemcitabine
    Gemcitabine will be administered to subjects with ECOG=0 or 1

Primary Outcome Measure

Progression-Free Survival [ Time Frame: 12 mths ]

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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