Trial Outcomes & Findings for Neoantigen Peptide Vaccine Strategy in Pancreatic Cancer Patients Following Surgical Resection and Adjuvant Chemotherapy (NCT NCT03956056)
NCT ID: NCT03956056
Last Updated: 2024-07-17
Results Overview
-Toxicity will be graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events v5.0.
Recruitment status
TERMINATED
Study phase
PHASE1
Target enrollment
12 participants
Primary outcome timeframe
Through 30 days following completion of treatment (median follow-up of 107 days, full range of 88-157 days)
Results posted on
2024-07-17
Participant Flow
Participant milestones
| Measure |
Neoantigen Peptide Vaccine
The schedule for vaccination will be Days 1, 4, 8, 15, and 22 (delays of up to 96 hours are allowed for each dose based on the adverse events experienced). Additional vaccinations will be given on Days 50 and 78 (+/- 2 weeks). The first vaccine dose may be administered following confirmation of disease-free status and within 90 days following date of repeat imaging. All study injections will be given subcutaneously and co-administered with poly-ICLC by a trained healthcare provider.
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|---|---|
|
Overall Study
STARTED
|
12
|
|
Overall Study
COMPLETED
|
9
|
|
Overall Study
NOT COMPLETED
|
3
|
Reasons for withdrawal
| Measure |
Neoantigen Peptide Vaccine
The schedule for vaccination will be Days 1, 4, 8, 15, and 22 (delays of up to 96 hours are allowed for each dose based on the adverse events experienced). Additional vaccinations will be given on Days 50 and 78 (+/- 2 weeks). The first vaccine dose may be administered following confirmation of disease-free status and within 90 days following date of repeat imaging. All study injections will be given subcutaneously and co-administered with poly-ICLC by a trained healthcare provider.
|
|---|---|
|
Overall Study
Cannot make vaccine due to lack of tissue variants
|
2
|
|
Overall Study
Lack of Efficacy
|
1
|
Baseline Characteristics
Neoantigen Peptide Vaccine Strategy in Pancreatic Cancer Patients Following Surgical Resection and Adjuvant Chemotherapy
Baseline characteristics by cohort
| Measure |
Neoantigen Peptide Vaccine
n=12 Participants
The schedule for vaccination will be Days 1, 4, 8, 15, and 22 (delays of up to 96 hours are allowed for each dose based on the adverse events experienced). Additional vaccinations will be given on Days 50 and 78 (+/- 2 weeks). The first vaccine dose may be administered following confirmation of disease-free status and within 90 days following date of repeat imaging. All study injections will be given subcutaneously and co-administered with poly-ICLC by a trained healthcare provider.
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|---|---|
|
Age, Continuous
|
66 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
6 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
6 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
12 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 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
|
12 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
12 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Through 30 days following completion of treatment (median follow-up of 107 days, full range of 88-157 days)Population: 2 participants were not evaluable for this outcome measure as they did not start vaccine treatment.
-Toxicity will be graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events v5.0.
Outcome measures
| Measure |
Neoantigen Peptide Vaccine
n=10 Participants
The schedule for vaccination will be Days 1, 4, 8, 15, and 22 (delays of up to 96 hours are allowed for each dose based on the adverse events experienced). Additional vaccinations will be given on Days 50 and 78 (+/- 2 weeks). The first vaccine dose may be administered following confirmation of disease-free status and within 90 days following date of repeat imaging. All study injections will be given subcutaneously and co-administered with poly-ICLC by a trained healthcare provider.
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|---|---|
|
Safety of Neoantigen Peptide Vaccine as Measured by the Number of Serious Adverse Events
Grade 3 anemia
|
1 participants
|
|
Safety of Neoantigen Peptide Vaccine as Measured by the Number of Serious Adverse Events
Grade 3 ascites
|
1 participants
|
SECONDARY outcome
Timeframe: Baseline through week 52Population: 3 participants were not evaluable for this outcome measure. 2 participants were not enrolled but vaccine wasn't able to be made due to lack of tissue variants. 1 participant did not complete treatment due to disease progression.
The ELISpot assay was performed after in vitro culture of patient PBMC with neoantigen peptide for \~12 days. The number of spot-forming T cells, a surrogate for the number of neoantigen-specific T cells, was determined after neoantigen peptide re-stimulation for the duration of the assay (48 hours) and compared to that of control cells that were not re-stimulated with neoantigen during the assay. Independent t tests between pre- and post-vaccination PBMCs were performed.
Outcome measures
| Measure |
Neoantigen Peptide Vaccine
n=9 Participants
The schedule for vaccination will be Days 1, 4, 8, 15, and 22 (delays of up to 96 hours are allowed for each dose based on the adverse events experienced). Additional vaccinations will be given on Days 50 and 78 (+/- 2 weeks). The first vaccine dose may be administered following confirmation of disease-free status and within 90 days following date of repeat imaging. All study injections will be given subcutaneously and co-administered with poly-ICLC by a trained healthcare provider.
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|---|---|
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Number of Participants With Immune Response as Measured by ELISPOT Analysis
|
9 Participants
|
SECONDARY outcome
Timeframe: Baseline through week 52Population: 3 participants were not evaluable for this outcome measure. 2 participants were not enrolled but vaccine wasn't able to be made due to lack of tissue variants. 1 participant did not complete treatment due to disease progression.
Multiparametric flow cytometry was performed as a second readout to characterize the neoantigen-specific T cell response. Markers included CD4, CD8, IFNγ, and a viability marker. After culture, as described above, T cells were stimulated overnight with/without neoantigen and stained with fluorescent antibodies specific for the various markers. Data were analyzed by comparing, between pre- and post-vaccination PBMCs, the percent ratio of IFNγ+ CD4/CD8 cells with neoantigen stimulation over those without stimulation; a \>2-fold increase in response after vaccination was considered positive.
Outcome measures
| Measure |
Neoantigen Peptide Vaccine
n=9 Participants
The schedule for vaccination will be Days 1, 4, 8, 15, and 22 (delays of up to 96 hours are allowed for each dose based on the adverse events experienced). Additional vaccinations will be given on Days 50 and 78 (+/- 2 weeks). The first vaccine dose may be administered following confirmation of disease-free status and within 90 days following date of repeat imaging. All study injections will be given subcutaneously and co-administered with poly-ICLC by a trained healthcare provider.
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|---|---|
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Number of Participants With Immune Response as Measured by Multiparametric Flow Cytometry (CD4)
|
5 Participants
|
SECONDARY outcome
Timeframe: Baseline through week 52Population: 3 participants were not evaluable for this outcome measure. 2 participants were not enrolled but vaccine wasn't able to be made due to lack of tissue variants. 1 participant did not complete treatment due to disease progression.
Multiparametric flow cytometry was performed as a second readout to characterize the neoantigen-specific T cell response. Markers included CD4, CD8, IFNγ, and a viability marker. After culture, as described above, T cells were stimulated overnight with/without neoantigen and stained with fluorescent antibodies specific for the various markers. Data were analyzed by comparing, between pre- and post-vaccination PBMCs, the percent ratio of IFNγ+ CD4/CD8 cells with neoantigen stimulation over those without stimulation; a \>2-fold increase in response after vaccination was considered positive.
Outcome measures
| Measure |
Neoantigen Peptide Vaccine
n=9 Participants
The schedule for vaccination will be Days 1, 4, 8, 15, and 22 (delays of up to 96 hours are allowed for each dose based on the adverse events experienced). Additional vaccinations will be given on Days 50 and 78 (+/- 2 weeks). The first vaccine dose may be administered following confirmation of disease-free status and within 90 days following date of repeat imaging. All study injections will be given subcutaneously and co-administered with poly-ICLC by a trained healthcare provider.
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|---|---|
|
Number of Participants With Immune Response as Measured by Multiparametric Flow Cytometry (CD8)
|
7 Participants
|
Adverse Events
Neoantigen Peptide Vaccine
Serious events: 1 serious events
Other events: 10 other events
Deaths: 4 deaths
Serious adverse events
| Measure |
Neoantigen Peptide Vaccine
n=10 participants at risk
The schedule for vaccination will be Days 1, 4, 8, 15, and 22 (delays of up to 96 hours are allowed for each dose based on the adverse events experienced). Additional vaccinations will be given on Days 50 and 78 (+/- 2 weeks). The first vaccine dose may be administered following confirmation of disease-free status and within 90 days following date of repeat imaging. All study injections will be given subcutaneously and co-administered with poly-ICLC by a trained healthcare provider.
|
|---|---|
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Blood and lymphatic system disorders
Anemia
|
10.0%
1/10 • Adverse events were collected from start of treatment through 30 days following the last day of treatment (approximately day 108).
|
|
Gastrointestinal disorders
Ascites
|
10.0%
1/10 • Adverse events were collected from start of treatment through 30 days following the last day of treatment (approximately day 108).
|
Other adverse events
| Measure |
Neoantigen Peptide Vaccine
n=10 participants at risk
The schedule for vaccination will be Days 1, 4, 8, 15, and 22 (delays of up to 96 hours are allowed for each dose based on the adverse events experienced). Additional vaccinations will be given on Days 50 and 78 (+/- 2 weeks). The first vaccine dose may be administered following confirmation of disease-free status and within 90 days following date of repeat imaging. All study injections will be given subcutaneously and co-administered with poly-ICLC by a trained healthcare provider.
|
|---|---|
|
Blood and lymphatic system disorders
Anemia
|
20.0%
2/10 • Adverse events were collected from start of treatment through 30 days following the last day of treatment (approximately day 108).
|
|
Ear and labyrinth disorders
Tinnitus
|
10.0%
1/10 • Adverse events were collected from start of treatment through 30 days following the last day of treatment (approximately day 108).
|
|
Eye disorders
Cataract correction surgery
|
10.0%
1/10 • Adverse events were collected from start of treatment through 30 days following the last day of treatment (approximately day 108).
|
|
Gastrointestinal disorders
Belching
|
10.0%
1/10 • Adverse events were collected from start of treatment through 30 days following the last day of treatment (approximately day 108).
|
|
Gastrointestinal disorders
Constipation
|
20.0%
2/10 • Adverse events were collected from start of treatment through 30 days following the last day of treatment (approximately day 108).
|
|
Gastrointestinal disorders
Diarrhea
|
20.0%
2/10 • Adverse events were collected from start of treatment through 30 days following the last day of treatment (approximately day 108).
|
|
Gastrointestinal disorders
Dyspepsia
|
10.0%
1/10 • Adverse events were collected from start of treatment through 30 days following the last day of treatment (approximately day 108).
|
|
Gastrointestinal disorders
Mucositis oral
|
20.0%
2/10 • Adverse events were collected from start of treatment through 30 days following the last day of treatment (approximately day 108).
|
|
Gastrointestinal disorders
Nausea
|
40.0%
4/10 • Adverse events were collected from start of treatment through 30 days following the last day of treatment (approximately day 108).
|
|
Gastrointestinal disorders
Sore under tongue
|
10.0%
1/10 • Adverse events were collected from start of treatment through 30 days following the last day of treatment (approximately day 108).
|
|
Gastrointestinal disorders
Vomiting
|
20.0%
2/10 • Adverse events were collected from start of treatment through 30 days following the last day of treatment (approximately day 108).
|
|
General disorders
Body aches
|
10.0%
1/10 • Adverse events were collected from start of treatment through 30 days following the last day of treatment (approximately day 108).
|
|
General disorders
Chills
|
30.0%
3/10 • Adverse events were collected from start of treatment through 30 days following the last day of treatment (approximately day 108).
|
|
General disorders
Chills (intermittent)
|
10.0%
1/10 • Adverse events were collected from start of treatment through 30 days following the last day of treatment (approximately day 108).
|
|
General disorders
Edema at injection site
|
50.0%
5/10 • Adverse events were collected from start of treatment through 30 days following the last day of treatment (approximately day 108).
|
|
General disorders
Fatigue
|
50.0%
5/10 • Adverse events were collected from start of treatment through 30 days following the last day of treatment (approximately day 108).
|
|
General disorders
Fever
|
40.0%
4/10 • Adverse events were collected from start of treatment through 30 days following the last day of treatment (approximately day 108).
|
|
General disorders
Hip pain
|
10.0%
1/10 • Adverse events were collected from start of treatment through 30 days following the last day of treatment (approximately day 108).
|
|
General disorders
Injection site pain
|
20.0%
2/10 • Adverse events were collected from start of treatment through 30 days following the last day of treatment (approximately day 108).
|
|
General disorders
Injection site reaction
|
40.0%
4/10 • Adverse events were collected from start of treatment through 30 days following the last day of treatment (approximately day 108).
|
|
General disorders
Left knee pain
|
10.0%
1/10 • Adverse events were collected from start of treatment through 30 days following the last day of treatment (approximately day 108).
|
|
General disorders
Malaise
|
10.0%
1/10 • Adverse events were collected from start of treatment through 30 days following the last day of treatment (approximately day 108).
|
|
General disorders
Non-cardiac chest pain
|
10.0%
1/10 • Adverse events were collected from start of treatment through 30 days following the last day of treatment (approximately day 108).
|
|
General disorders
Pain at surgical site
|
10.0%
1/10 • Adverse events were collected from start of treatment through 30 days following the last day of treatment (approximately day 108).
|
|
General disorders
Right buttock pain
|
10.0%
1/10 • Adverse events were collected from start of treatment through 30 days following the last day of treatment (approximately day 108).
|
|
General disorders
Shoulder pain
|
10.0%
1/10 • Adverse events were collected from start of treatment through 30 days following the last day of treatment (approximately day 108).
|
|
General disorders
Urine pain
|
10.0%
1/10 • Adverse events were collected from start of treatment through 30 days following the last day of treatment (approximately day 108).
|
|
Infections and infestations
COVID-19 infection
|
10.0%
1/10 • Adverse events were collected from start of treatment through 30 days following the last day of treatment (approximately day 108).
|
|
Infections and infestations
Sinusitis
|
10.0%
1/10 • Adverse events were collected from start of treatment through 30 days following the last day of treatment (approximately day 108).
|
|
Infections and infestations
Urinary tract infection
|
10.0%
1/10 • Adverse events were collected from start of treatment through 30 days following the last day of treatment (approximately day 108).
|
|
Injury, poisoning and procedural complications
Fall
|
10.0%
1/10 • Adverse events were collected from start of treatment through 30 days following the last day of treatment (approximately day 108).
|
|
Investigations
Alkaline phosphatase increased
|
80.0%
8/10 • Adverse events were collected from start of treatment through 30 days following the last day of treatment (approximately day 108).
|
|
Investigations
Aspartate aminotransferase increased
|
10.0%
1/10 • Adverse events were collected from start of treatment through 30 days following the last day of treatment (approximately day 108).
|
|
Investigations
Blood lactate dehydrogenase increased
|
10.0%
1/10 • Adverse events were collected from start of treatment through 30 days following the last day of treatment (approximately day 108).
|
|
Investigations
Creatinine decreased
|
10.0%
1/10 • Adverse events were collected from start of treatment through 30 days following the last day of treatment (approximately day 108).
|
|
Investigations
Lymphocyte count decreased
|
30.0%
3/10 • Adverse events were collected from start of treatment through 30 days following the last day of treatment (approximately day 108).
|
|
Investigations
Platelet count decreased
|
30.0%
3/10 • Adverse events were collected from start of treatment through 30 days following the last day of treatment (approximately day 108).
|
|
Investigations
Weight loss
|
10.0%
1/10 • Adverse events were collected from start of treatment through 30 days following the last day of treatment (approximately day 108).
|
|
Investigations
White blood cell count decreased
|
20.0%
2/10 • Adverse events were collected from start of treatment through 30 days following the last day of treatment (approximately day 108).
|
|
Metabolism and nutrition disorders
Anorexia
|
30.0%
3/10 • Adverse events were collected from start of treatment through 30 days following the last day of treatment (approximately day 108).
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
20.0%
2/10 • Adverse events were collected from start of treatment through 30 days following the last day of treatment (approximately day 108).
|
|
Metabolism and nutrition disorders
Hypoalbuminemia
|
10.0%
1/10 • Adverse events were collected from start of treatment through 30 days following the last day of treatment (approximately day 108).
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
10.0%
1/10 • Adverse events were collected from start of treatment through 30 days following the last day of treatment (approximately day 108).
|
|
Musculoskeletal and connective tissue disorders
Generalized muscle weakness
|
10.0%
1/10 • Adverse events were collected from start of treatment through 30 days following the last day of treatment (approximately day 108).
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
40.0%
4/10 • Adverse events were collected from start of treatment through 30 days following the last day of treatment (approximately day 108).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Pancreatic adenocarcinoma
|
10.0%
1/10 • Adverse events were collected from start of treatment through 30 days following the last day of treatment (approximately day 108).
|
|
Nervous system disorders
Dizziness
|
40.0%
4/10 • Adverse events were collected from start of treatment through 30 days following the last day of treatment (approximately day 108).
|
|
Nervous system disorders
Headache
|
40.0%
4/10 • Adverse events were collected from start of treatment through 30 days following the last day of treatment (approximately day 108).
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
10.0%
1/10 • Adverse events were collected from start of treatment through 30 days following the last day of treatment (approximately day 108).
|
|
Nervous system disorders
Tremor
|
10.0%
1/10 • Adverse events were collected from start of treatment through 30 days following the last day of treatment (approximately day 108).
|
|
Psychiatric disorders
Depression
|
10.0%
1/10 • Adverse events were collected from start of treatment through 30 days following the last day of treatment (approximately day 108).
|
|
Psychiatric disorders
Insomnia
|
10.0%
1/10 • Adverse events were collected from start of treatment through 30 days following the last day of treatment (approximately day 108).
|
|
Renal and urinary disorders
Renal calculi
|
10.0%
1/10 • Adverse events were collected from start of treatment through 30 days following the last day of treatment (approximately day 108).
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
10.0%
1/10 • Adverse events were collected from start of treatment through 30 days following the last day of treatment (approximately day 108).
|
|
Respiratory, thoracic and mediastinal disorders
Sinus disorder
|
10.0%
1/10 • Adverse events were collected from start of treatment through 30 days following the last day of treatment (approximately day 108).
|
|
Skin and subcutaneous tissue disorders
Body odor
|
10.0%
1/10 • Adverse events were collected from start of treatment through 30 days following the last day of treatment (approximately day 108).
|
|
Skin and subcutaneous tissue disorders
Bruising at injection site
|
10.0%
1/10 • Adverse events were collected from start of treatment through 30 days following the last day of treatment (approximately day 108).
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
10.0%
1/10 • Adverse events were collected from start of treatment through 30 days following the last day of treatment (approximately day 108).
|
|
Skin and subcutaneous tissue disorders
Rash on arms
|
10.0%
1/10 • Adverse events were collected from start of treatment through 30 days following the last day of treatment (approximately day 108).
|
|
Skin and subcutaneous tissue disorders
Skin rash on hands
|
10.0%
1/10 • Adverse events were collected from start of treatment through 30 days following the last day of treatment (approximately day 108).
|
|
Skin and subcutaneous tissue disorders
Skin redness on injection sites
|
50.0%
5/10 • Adverse events were collected from start of treatment through 30 days following the last day of treatment (approximately day 108).
|
|
Vascular disorders
Flushing
|
10.0%
1/10 • Adverse events were collected from start of treatment through 30 days following the last day of treatment (approximately day 108).
|
|
Vascular disorders
Hot flashes
|
50.0%
5/10 • Adverse events were collected from start of treatment through 30 days following the last day of treatment (approximately day 108).
|
|
Vascular disorders
Hypertension
|
20.0%
2/10 • Adverse events were collected from start of treatment through 30 days following the last day of treatment (approximately day 108).
|
|
Vascular disorders
Hypotension
|
20.0%
2/10 • Adverse events were collected from start of treatment through 30 days following the last day of treatment (approximately day 108).
|
Additional Information
William Gillanders, M.D.
Washington University School of Medicine
Phone: 314-747-0072
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place