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.
This is a two-cohort, open-label, randomized phase 2 study to evaluate the safety and efficacy (as assessed by PFS) of the NANT Pancreatic Cancer Vaccine regimen (experimental arms) vs SoC therapy (control arms) as first-line treatment for subjects with metastatic pancreatic cancer. Subjects will be enrolled into two independent cohorts based on ECOG status. Subjects with ECOG 0-1 will be randomized 1:1 to receive the NANT Pancreatic Cancer Vaccine regimen (experimental arm) or gemcitabine in combination with nab-paclitaxel (control arm), while subjects with ECOG 2 will be randomized 1:1 to receive the NANT Pancreatic Cancer Vaccine regimen (experimental arm) or gemcitabine monotherapy (control arm). The experimental arms will be administered in two phases, an induction and a subsequent maintenance phase. The treatment regimen administered in the experimental arms will be identical for all subjects, independent of ECOG status. Subjects may continue induction treatment for up to 1 year. 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) after 1 year of induction phase treatment may enter the maintenance phase at the Investigator's discretion. Subjects may remain on the maintenance phase of the study for up to 1 year. Treatment in the study will be discontinued if the subject experiences confirmed PD or unacceptable toxicity, withdraws consent, or if the Investigator feels it is no longer in the subject's best interest to continue treatment. Subjects receiving treatment in the control arms may cross over to treatment in the induction phase of the experimental arms after experiencing PD. Subjects receiving treatment in the experimental arms with an initial assessment of PD per RECIST 1.1 may, at the discretion of the Investigator, continue to receive study treatment until PD is confirmed. The maximum time on study treatment is 2 years.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Gemcitabine is a type of chemotherapy medication used to interfere with the cancer cells' ability to grow and divide.
NAB-paclitaxel is a type of chemotherapy called a microtubule inhibitor. Microtubule inhibitors interfere with a cancer cell's ability to grow and divide.
Albumin-binding prodrug of doxorubicin HCl
Chan Soon-Shiong Institute for Medicine
El Segundo, California, United States
Progression-Free Survival
Compare the efficacy of the NANT Pancreatic Cancer Vaccine regimen vs standard-of-care (SoC) therapy as first-line treatment for patients with metastatic pancreatic cancer as assessed by progression-free survival (PFS) using RECIST Version 1.1
Time frame: 12 mths
Overall Survival
Overall Survival from first treatment to date of death (any cause)
Time frame: 24 months
Overall Response Rate
Overall Response Rate, as determined by the percentage of patients achieving Partial or Complete response per RECIST 1.1 and irRC
Time frame: 19 months
Duration of Response
Duration of Response from date of first response to date of disease progression or death (any cause), per RECIST 1.1 and irRC
Time frame: 19 months
Disease Control Rate
Disease Control Rate: the number of patients with a CR, PR or SD lasting at least 2 months per RECIST 1.1 and irRC
Time frame: 19 months
Quality of Life by Patient-Reported Outcomes
Quality of Life as assessed by Patient Reported Outcomes using the FACT-C questionnaire
Time frame: 19 months
Progression Free Survival
Progression Free Survival from baseline to progression per irRC
Time frame: 12 months
Evaluation of safety as determined by incidence or treatment-emergent adverse events
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Recombinant human super agonist interleukin-15 (IL-15) complex
Ad5 \[E1-, E2b-\]-CEA
Ad5 \[E1-, E2b-\]-human epidermal growth factor receptor 2 \[HER2\] vaccine
Ad5 \[E1-, E2b-\]-Brachyury vaccine
Ad5 \[E1-, E2b-\]-mucin 1\[MUC1\]
Vaccine derived from recombinant Saccharomyces cerevisiae yeast expressing mutant Ras proteins
CEA yeast vaccine
Brachyury yeast vaccine
NK-92 \[CD16.158V, ER IL-2\]
Avelumab
Bevacizumab
Capecitabine
2-\[bis(2-chloroethyl)amino\]tetrahydro-2H-1,3,2-oxazaphosphorine 2-oxide monohydrate
5-fluoro-2,4 (1H,3H)-pyrimidinedione
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
Incidence of treatment -emergent adverse events using NCI CTCAE Version 4.03
Time frame: 19 months