Trial Outcomes & Findings for QUILT-3.070:Pancreatic Cancer Vaccine: Subjects With Pancreatic Cancer Who Have Progressed on or After Standard-of-care Therapy (NCT NCT03387098)
NCT ID: NCT03387098
Last Updated: 2024-05-22
Results Overview
Phase 1b primary endpoint
Recruitment status
TERMINATED
Study phase
PHASE1/PHASE2
Target enrollment
4 participants
Primary outcome timeframe
30 days after last dose, up to 8 months
Results posted on
2024-05-22
Participant Flow
Only the Phase 1b portion of the study enrolled participants. The study was terminated early, so no participants were enrolled on the Phase 2 portion of the study.
Participant milestones
| Measure |
NANT Pancreatic Cancer Vaccine
The following drugs will be given to the trial participants: GI-4000, haNK, ALT-803, ETBX-011, capecitabine, cyclophosphamide, fluorouracil, leucovorin, nab-paclitaxel, omega-3-acid ethyl esters, oxaliplatin, and SBRT.
Aldoxorubicin hydrochloride ALT-803: Recombinant human super agonist interleukin-15 (IL-15) complex ETBX-011: Ad5 \[E1-, E2b-\]-CEA GI-4000: Vaccine derived from recombinant Saccharomyces cerevisiae yeast expressing mutant Ras proteins haNK for infusion: NK-92 \[CD16.158V, ER IL-2\] avelumab: Recombinant human anti-PD-L1 IgG1 monoclonal antibody bevacizumab: Recombinant human anti-VEGF IgG1 monoclonal Capecitabine: 5'-deoxy-5-fluoro-N-\[(pentyloxy) carbonyl\]-cytidine
Cyclophosphamide: 2-\[bis(2-chloroethyl)amino\]tetrahydro-2H-1,3,2-oxazaphosphorine 2-oxide monohydrate
Fluorouracil: 5-fluoro-2,4 (1H,3H)-pyrimidinedione
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
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
lovaza: Omega-3-acid ethyl esters
Oxaliplatin: cis-\[(1 R,2 R)-1,2-cyclohexanediamine-N,N'\] \[oxalato(2-)- O,O'\] platinum
SBRT: Stereotactic Body Radiation Therapy
|
|---|---|
|
Overall Study
STARTED
|
4
|
|
Overall Study
COMPLETED
|
0
|
|
Overall Study
NOT COMPLETED
|
4
|
Reasons for withdrawal
| Measure |
NANT Pancreatic Cancer Vaccine
The following drugs will be given to the trial participants: GI-4000, haNK, ALT-803, ETBX-011, capecitabine, cyclophosphamide, fluorouracil, leucovorin, nab-paclitaxel, omega-3-acid ethyl esters, oxaliplatin, and SBRT.
Aldoxorubicin hydrochloride ALT-803: Recombinant human super agonist interleukin-15 (IL-15) complex ETBX-011: Ad5 \[E1-, E2b-\]-CEA GI-4000: Vaccine derived from recombinant Saccharomyces cerevisiae yeast expressing mutant Ras proteins haNK for infusion: NK-92 \[CD16.158V, ER IL-2\] avelumab: Recombinant human anti-PD-L1 IgG1 monoclonal antibody bevacizumab: Recombinant human anti-VEGF IgG1 monoclonal Capecitabine: 5'-deoxy-5-fluoro-N-\[(pentyloxy) carbonyl\]-cytidine
Cyclophosphamide: 2-\[bis(2-chloroethyl)amino\]tetrahydro-2H-1,3,2-oxazaphosphorine 2-oxide monohydrate
Fluorouracil: 5-fluoro-2,4 (1H,3H)-pyrimidinedione
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
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
lovaza: Omega-3-acid ethyl esters
Oxaliplatin: cis-\[(1 R,2 R)-1,2-cyclohexanediamine-N,N'\] \[oxalato(2-)- O,O'\] platinum
SBRT: Stereotactic Body Radiation Therapy
|
|---|---|
|
Overall Study
progressive disease
|
1
|
|
Overall Study
Withdrawal by Subject
|
2
|
|
Overall Study
study terminated by sponsor
|
1
|
Baseline Characteristics
QUILT-3.070:Pancreatic Cancer Vaccine: Subjects With Pancreatic Cancer Who Have Progressed on or After Standard-of-care Therapy
Baseline characteristics by cohort
| Measure |
NANT Pancreatic Cancer Vaccine
n=4 Participants
The following drugs will be given to the trial participants: GI-4000, haNK, ALT-803, ETBX-011, capecitabine, cyclophosphamide, fluorouracil, leucovorin, nab-paclitaxel, omega-3-acid ethyl esters, oxaliplatin, and SBRT.
Aldoxorubicin hydrochloride ALT-803: Recombinant human super agonist interleukin-15 (IL-15) complex ETBX-011: Ad5 \[E1-, E2b-\]-CEA GI-4000: Vaccine derived from recombinant Saccharomyces cerevisiae yeast expressing mutant Ras proteins haNK for infusion: NK-92 \[CD16.158V, ER IL-2\] avelumab: Recombinant human anti-PD-L1 IgG1 monoclonal antibody bevacizumab: Recombinant human anti-VEGF IgG1 monoclonal Capecitabine: 5'-deoxy-5-fluoro-N-\[(pentyloxy) carbonyl\]-cytidine
Cyclophosphamide: 2-\[bis(2-chloroethyl)amino\]tetrahydro-2H-1,3,2-oxazaphosphorine 2-oxide monohydrate
Fluorouracil: 5-fluoro-2,4 (1H,3H)-pyrimidinedione
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
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
lovaza: Omega-3-acid ethyl esters
Oxaliplatin: cis-\[(1 R,2 R)-1,2-cyclohexanediamine-N,N'\] \[oxalato(2-)- O,O'\] platinum
SBRT: Stereotactic Body Radiation Therapy
|
|---|---|
|
Age, Continuous
|
56.3 years
STANDARD_DEVIATION 11.62 • n=5 Participants
|
|
Sex: Female, Male
Female
|
1 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
3 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
1 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
3 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
2 Participants
n=5 Participants
|
|
subjects with pancreatic cancer who have progressed on or after standard-of-care therapy
|
4 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 30 days after last dose, up to 8 monthsPhase 1b primary endpoint
Outcome measures
| Measure |
NANT Pancreatic Cancer Vaccine
n=4 Participants
The following drugs will be given to the trial participants: GI-4000, haNK, ALT-803, ETBX-011, capecitabine, cyclophosphamide, fluorouracil, leucovorin, nab-paclitaxel, omega-3-acid ethyl esters, oxaliplatin, and SBRT.
Aldoxorubicin hydrochloride ALT-803: Recombinant human super agonist interleukin-15 (IL-15) complex ETBX-011: Ad5 \[E1-, E2b-\]-CEA GI-4000: Vaccine derived from recombinant Saccharomyces cerevisiae yeast expressing mutant Ras proteins haNK for infusion: NK-92 \[CD16.158V, ER IL-2\] avelumab: Recombinant human anti-PD-L1 IgG1 monoclonal antibody bevacizumab: Recombinant human anti-VEGF IgG1 monoclonal Capecitabine: 5'-deoxy-5-fluoro-N-\[(pentyloxy) carbonyl\]-cytidine
Cyclophosphamide: 2-\[bis(2-chloroethyl)amino\]tetrahydro-2H-1,3,2-oxazaphosphorine 2-oxide monohydrate
Fluorouracil: 5-fluoro-2,4 (1H,3H)-pyrimidinedione
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
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
lovaza: Omega-3-acid ethyl esters
Oxaliplatin: cis-\[(1 R,2 R)-1,2-cyclohexanediamine-N,N'\] \[oxalato(2-)- O,O'\] platinum
SBRT: Stereotactic Body Radiation Therapy
|
|---|---|
|
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.
|
4 Participants
|
Adverse Events
NANT Pancreatic Cancer Vaccine
Serious events: 2 serious events
Other events: 4 other events
Deaths: 2 deaths
Serious adverse events
| Measure |
NANT Pancreatic Cancer Vaccine
n=4 participants at risk
The following drugs will be given to the trial participants: GI-4000, haNK, ALT-803, ETBX-011, capecitabine, cyclophosphamide, fluorouracil, leucovorin, nab-paclitaxel, omega-3-acid ethyl esters, oxaliplatin, and SBRT.
Aldoxorubicin hydrochloride ALT-803: Recombinant human super agonist interleukin-15 (IL-15) complex ETBX-011: Ad5 \[E1-, E2b-\]-CEA GI-4000: Vaccine derived from recombinant Saccharomyces cerevisiae yeast expressing mutant Ras proteins haNK for infusion: NK-92 \[CD16.158V, ER IL-2\] avelumab: Recombinant human anti-PD-L1 IgG1 monoclonal antibody bevacizumab: Recombinant human anti-VEGF IgG1 monoclonal Capecitabine: 5'-deoxy-5-fluoro-N-\[(pentyloxy) carbonyl\]-cytidine
Cyclophosphamide: 2-\[bis(2-chloroethyl)amino\]tetrahydro-2H-1,3,2-oxazaphosphorine 2-oxide monohydrate
Fluorouracil: 5-fluoro-2,4 (1H,3H)-pyrimidinedione
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
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
lovaza: Omega-3-acid ethyl esters
Oxaliplatin: cis-\[(1 R,2 R)-1,2-cyclohexanediamine-N,N'\] \[oxalato(2-)- O,O'\] platinum
SBRT: Stereotactic Body Radiation Therapy
|
|---|---|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
25.0%
1/4 • Up to 8 months (30 days after the subject's last dose of study treatment)
|
|
Gastrointestinal disorders
Gastric fistula
|
25.0%
1/4 • Up to 8 months (30 days after the subject's last dose of study treatment)
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Pancreatic carcinoma metastatic
|
25.0%
1/4 • Up to 8 months (30 days after the subject's last dose of study treatment)
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonia aspiration
|
25.0%
1/4 • Up to 8 months (30 days after the subject's last dose of study treatment)
|
Other adverse events
| Measure |
NANT Pancreatic Cancer Vaccine
n=4 participants at risk
The following drugs will be given to the trial participants: GI-4000, haNK, ALT-803, ETBX-011, capecitabine, cyclophosphamide, fluorouracil, leucovorin, nab-paclitaxel, omega-3-acid ethyl esters, oxaliplatin, and SBRT.
Aldoxorubicin hydrochloride ALT-803: Recombinant human super agonist interleukin-15 (IL-15) complex ETBX-011: Ad5 \[E1-, E2b-\]-CEA GI-4000: Vaccine derived from recombinant Saccharomyces cerevisiae yeast expressing mutant Ras proteins haNK for infusion: NK-92 \[CD16.158V, ER IL-2\] avelumab: Recombinant human anti-PD-L1 IgG1 monoclonal antibody bevacizumab: Recombinant human anti-VEGF IgG1 monoclonal Capecitabine: 5'-deoxy-5-fluoro-N-\[(pentyloxy) carbonyl\]-cytidine
Cyclophosphamide: 2-\[bis(2-chloroethyl)amino\]tetrahydro-2H-1,3,2-oxazaphosphorine 2-oxide monohydrate
Fluorouracil: 5-fluoro-2,4 (1H,3H)-pyrimidinedione
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
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
lovaza: Omega-3-acid ethyl esters
Oxaliplatin: cis-\[(1 R,2 R)-1,2-cyclohexanediamine-N,N'\] \[oxalato(2-)- O,O'\] platinum
SBRT: Stereotactic Body Radiation Therapy
|
|---|---|
|
General disorders
Fatigue
|
100.0%
4/4 • Up to 8 months (30 days after the subject's last dose of study treatment)
|
|
General disorders
Injection site reaction
|
100.0%
4/4 • Up to 8 months (30 days after the subject's last dose of study treatment)
|
|
General disorders
chills
|
75.0%
3/4 • Up to 8 months (30 days after the subject's last dose of study treatment)
|
|
General disorders
Mucosal inflamation
|
75.0%
3/4 • Up to 8 months (30 days after the subject's last dose of study treatment)
|
|
General disorders
Pyrexia
|
75.0%
3/4 • Up to 8 months (30 days after the subject's last dose of study treatment)
|
|
General disorders
Asthenia
|
50.0%
2/4 • Up to 8 months (30 days after the subject's last dose of study treatment)
|
|
General disorders
Influenza like illness
|
25.0%
1/4 • Up to 8 months (30 days after the subject's last dose of study treatment)
|
|
General disorders
Injection Site Pain
|
25.0%
1/4 • Up to 8 months (30 days after the subject's last dose of study treatment)
|
|
General disorders
Odema peripheral
|
25.0%
1/4 • Up to 8 months (30 days after the subject's last dose of study treatment)
|
|
General disorders
Pain
|
25.0%
1/4 • Up to 8 months (30 days after the subject's last dose of study treatment)
|
|
Investigations
weight decreased
|
75.0%
3/4 • Up to 8 months (30 days after the subject's last dose of study treatment)
|
|
Investigations
Eosinophil count increased
|
25.0%
1/4 • Up to 8 months (30 days after the subject's last dose of study treatment)
|
|
Investigations
Neutophil count decreased
|
25.0%
1/4 • Up to 8 months (30 days after the subject's last dose of study treatment)
|
|
Metabolism and nutrition disorders
Decreased appetite
|
75.0%
3/4 • Up to 8 months (30 days after the subject's last dose of study treatment)
|
|
Metabolism and nutrition disorders
Dehydration
|
25.0%
1/4 • Up to 8 months (30 days after the subject's last dose of study treatment)
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
25.0%
1/4 • Up to 8 months (30 days after the subject's last dose of study treatment)
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
25.0%
1/4 • Up to 8 months (30 days after the subject's last dose of study treatment)
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
25.0%
1/4 • Up to 8 months (30 days after the subject's last dose of study treatment)
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place