Pancreas CancerPhase 1NCT03956056
Neoantigen Peptide Vaccine Strategy in Pancreatic Cancer Patients Following Surgical Resection and Adjuvant Chemotherapy
A Phase 1 study testing Neoantigen Peptide Vaccine, Poly ICLC and Blood for immune monitoring in people with Pancreas Cancer and Pancreatic Cancer, run by Washington University School of Medicine at 1 site in United States.
Trial summary
This is a phase 1 open-label study to evaluate the safety and immunogenicity of a neoantigen peptide vaccine strategy in pancreatic cancer patients following surgical resection and adjuvant chemotherapy. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pancreas Cancer, Pancreatic Cancer, Cancer of the Pancreas
- What is being tested?
- Neoantigen Peptide Vaccine, Poly ICLC and Blood for immune monitoring
- Type of treatment
- Vaccines, Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteUnited States
- Study dates
- 13 Feb 2020to 6 Jul 2023
- Phase
- Phase 1
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Histologically or cytologically confirmed diagnosis of pancreatic adenocarcinoma; mixed histology will be included as long as the predominant histology is adenocarcinoma.
- Completed an R0 or R1 surgical resection as determined by pathology
- Pathology review demonstrates tumor cellularity no less than 30% in quantities sufficient to obtain 6-8 1mm biopsies from the original FFPE blocks.
- At least 18 years of age.
- Life expectancy of > 12 months.
- ECOG performance status ≤ 2
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- Normal bone marrow and organ function as defined below:
- WBC>=3,000/μL
- absolute neutrophil count>=1,500/μL
- platelets>=100,000/μL
- total bilirubin≤1.5 X institutional upper limit of normal (subjects with Gilbert's syndrome may be enrolled despite a total bilirubin level >1.5 mg/dL if their conjugated bilirubin is <1.5 x ULN)
- AST≤ X institutional upper limit of normal
- creatinine≤1.5 X institutional upper limit of normal
- International Normalized Ratio (INR) and activated partial thromboplastin time (PTT) < 1.5 x ULN provided the patient is not on anticoagulation therapy.
- 9-Patients who have had a stent placed for biliary obstruction can be included in the study provided serum bilirubin at time of enrollment is within protocol limits.
- Women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control, abstinence) prior to study entry and for the duration of study participation. Should a woman become pregnant or suspect she is pregnant while participating in this study, she must inform her treating physician immediately.
- Able to understand and willing to sign an IRB approved written informed consent document.
Who cannot join
- Evidence of neuroendocrine tumor, duodenal adenocarcinoma, or ampullary adenocarcinoma.
- Received neoadjuvant chemotherapy for their pancreatic adenocarcinoma
- Evidence of disease recurrence or metastasis following surgical resection at any time prior to the first vaccination administration. Most patients will undergo restaging midway through adjuvant chemotherapy and at the completion of therapy; however, timing of imaging is at the discretion of the patient's medical oncologist.
- History of other malignancy ≤ 3 years previous with the exception of basal cell or squamous cell carcinoma of the skin which were treated with local resection only, carcinoma in situ of the cervix, or LCIS/DCIS of the breast
- Known allergy, or history of serious adverse reaction to vaccines or TLR agonists such as anaphylaxis, hives, or respiratory difficulty.
- Acute or chronic, clinically significant hematologic, pulmonary, cardiovascular, hepatic renal, and/or other functional abnormality that would jeopardize the health and safety of the participant as determined by the investigator based on medical history, physical examination, laboratory values, and/or diagnostic studies.
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- A psychiatric illness/social situations that would limit compliance with study requirements as determined by the investigator from the medical history, physical exam, and/or medical record
- Prior or currently active autoimmune disease requiring management with immunosuppression. This includes inflammatory bowel disease, ulcerative colitis, Crohn's disease, systemic vasculitis, scleroderma, psoriasis, multiple sclerosis, hemolytic anemia, immune-mediated thrombocytopenia, rheumatoid arthritis, systemic lupus erythematosus, Sjögren's syndrome, sarcoidosis, or other rheumatologic disease or any other medical condition or use of medication (e.g., corticosteroids) which might make it difficult for the patient to complete the full course of treatments or to generate an immune response to vaccines. In the case of asthma or chronic obstructive pulmonary disease taking inhaled corticosteroids that does not require daily systemic corticosteroids is acceptable. Additionally, local acting steroids (topical, inhaled, or intraarticular) will be allowed. Patients on intermittent or short course steroids will be allow if the dose does not exceed 4 mg of dexamethasone (or equivalent) per day for > 7 consecutive days. Any patients receiving steroids should be discussed with the PI to determine if eligible.
- Pregnant and/or breastfeeding.
- Known HIV-positive status. These patients are ineligible because of the potential inability to generate an immune response to vaccines.
Trial locations and contacts
1 site in 1 country.
United States1 site
Washington University School of Medicine
St Louis, Missouri, 63110
About this study
Official title: A Phase 1 Clinical Trial to Evaluate the Safety and Immunogenicity of a Neoantigen Peptide Vaccine Strategy in Pancreatic Cancer Patients Following Surgical Resection and Adjuvant Chemotherapy
This is a phase 1 open-label study to evaluate the safety and immunogenicity of a neoantigen peptide vaccine strategy in pancreatic cancer patients following surgical resection and adjuvant chemotherapy. The neoantigen peptide vaccines will incorporate prioritized neoantigens and personalized mesothelin epitopes and will be co-administered with poly-ICLC. The hypothesis of this study is that neoantigen peptide vaccines will be safe and capable of generating measurable neoantigen-specific CD4 and CD8 T cell responses.
- Conditions
- Pancreas Cancer, Pancreatic Cancer, Cancer of the Pancreas
- Being tested
- Neoantigen Peptide Vaccine, Poly ICLC, Blood for immune monitoring
- Medical subject headings
- Pancreatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Neoantigen Peptide VaccineBiological
- Each pool of vaccine study drug + poly IC:LC will be administered to one of the four limbs (A - Right Arm, B - Left Arm, C - Right Leg, D - Left Leg) by subcutaneous (SC) injection.
Poly ICLCDrug
Also called Poly-ICLC, Hiltonol
- Each pool of vaccine study drug + poly IC:LC will be administered to one of the four limbs (A - Right Arm, B - Left Arm, C - Right Leg, D - Left Leg) by subcutaneous (SC) injection.
Blood for immune monitoringProcedure or surgery
-Baseline, day 1, day 22, day 50, day 78, week 25, and week 73
| Study group | Role | What they receive |
|---|---|---|
| Neoantigen Peptide Vaccine | Experimental | 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. Receives: Biological: Neoantigen Peptide Vaccine; Drug: Poly ICLC; Procedure: Blood for immune monitoring |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety of Neoantigen Peptide Vaccine as Measured by the Number of Serious Adverse Events
-Toxicity will be graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events v5.0.
Measured: Through 30 days following completion of treatment (median follow-up of 107 days, full range of 88-157 days)
Secondary outcomes (3)
Number of Participants With Immune Response as Measured by ELISPOT Analysis
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.
Measured: Baseline through week 52
Number of Participants With Immune Response as Measured by Multiparametric Flow Cytometry (CD4)
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.
Measured: Baseline through week 52
Number of Participants With Immune Response as Measured by Multiparametric Flow Cytometry (CD8)
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.
Measured: Baseline through week 52
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 May 2019
- Study start13 Feb 2020
- Primary completion21 Jul 2022
- Study completion6 Jul 2023
Why it stopped: Insufficient funding/staff
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Pancreas CancerStudies of the same condition, open and under way.
- More trials run by Washington University School of MedicineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Washington University School of Medicine
- Sponsor type
- University, hospital or other
- Collaborators
- National Institutes of Health (NIH), National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- William E Gillanders, M.D., Principal investigator, Washington University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03956056
- Sponsor's protocol ID
- 201908124
- Other IDs
- P50CA196510-03
- Status last verified
- Jun 2024
- First submitted
- 15 May 2019
- Last updated
- 17 Jul 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1 Clinical Trial to Evaluate the Safety and Immunogenicity of a Neoantigen Peptide Vaccine Strategy in Pancreatic Cancer Patients Following Surgical Resection and Adjuvant Chemotherapy
- ClinicalTrials.gov ID
- NCT03956056
- Acronym / sponsor ID
- 201908124
- Conditions
- Pancreas Cancer, Pancreatic Cancer, Cancer of the Pancreas
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Insufficient funding/staff
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Washington University School of MedicineUniversity, hospital or other
- Collaborators
- National Institutes of Health (NIH), National Cancer Institute (NCI)
- Study start
- 13 Feb 2020 (actual)
- Primary completion
- 21 Jul 2022 (actual)
- Study completion
- 6 Jul 2023 (actual)
- First posted
- 20 May 2019 (actual)
- Results
- Posted 31 May 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a phase 1 open-label study to evaluate the safety and immunogenicity of a neoantigen peptide vaccine strategy in pancreatic cancer patients following surgical resection and adjuvant chemotherapy. The neoantigen peptide vaccines will incorporate prioritized neoantigens and personalized mesothelin epitopes and will be co-administered with poly-ICLC. The hypothesis of this study is that neoantigen peptide vaccines will be safe and capable of generating measurable neoantigen-specific CD4 and CD8 T cell responses.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Neoantigen Peptide Vaccine | Experimental | Biological: Neoantigen Peptide Vaccine, Drug: Poly ICLC, Procedure: Blood for immune monitoringThe 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (17 listed)
- Histologically or cytologically confirmed diagnosis of pancreatic adenocarcinoma; mixed histology will be included as long as the predominant histology is adenocarcinoma.
- Completed an R0 or R1 surgical resection as determined by pathology
- Pathology review demonstrates tumor cellularity no less than 30% in quantities sufficient to obtain 6-8 1mm biopsies from the original FFPE blocks.
- At least 18 years of age.
- Life expectancy of > 12 months.
Key exclusion criteria (10 listed)
- Evidence of neuroendocrine tumor, duodenal adenocarcinoma, or ampullary adenocarcinoma.
- Received neoadjuvant chemotherapy for their pancreatic adenocarcinoma
- Evidence of disease recurrence or metastasis following surgical resection at any time prior to the first vaccination administration. Most patients will undergo restaging midway through adjuvant chemotherapy and at the completion of therapy; however, timing of imaging is at the discretion of the patient's medical oncologist.
- History of other malignancy ≤ 3 years previous with the exception of basal cell or squamous cell carcinoma of the skin which were treated with local resection only, carcinoma in situ of the cervix, or LCIS/DCIS of the breast
- Known allergy, or history of serious adverse reaction to vaccines or TLR agonists such as anaphylaxis, hives, or respiratory difficulty.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Neoantigen Peptide Vaccine• Each pool of vaccine study drug + poly IC:LC will be administered to one of the four limbs (A - Right Arm, B - Left Arm, C - Right Leg, D - Left Leg) by subcutaneous (SC) injection. | Biological | Neoantigen Peptide Vaccine |
| Poly ICLCAlso: Poly-ICLC, Hiltonol• Each pool of vaccine study drug + poly IC:LC will be administered to one of the four limbs (A - Right Arm, B - Left Arm, C - Right Leg, D - Left Leg) by subcutaneous (SC) injection. | Drug | Neoantigen Peptide Vaccine |
| Blood for immune monitoring-Baseline, day 1, day 22, day 50, day 78, week 25, and week 73 | Procedure or surgery | Neoantigen Peptide Vaccine |
Primary outcome
Safety of Neoantigen Peptide Vaccine as Measured by the Number of Serious Adverse Events
Time frame: Through 30 days following completion of treatment (median follow-up of 107 days, full range of 88-157 days)
-Toxicity will be graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events v5.0.
3 secondary outcomes
Number of Participants With Immune Response as Measured by ELISPOT Analysis
Time frame: Baseline through week 52
Number of Participants With Immune Response as Measured by Multiparametric Flow Cytometry (CD4)
Time frame: Baseline through week 52
Number of Participants With Immune Response as Measured by Multiparametric Flow Cytometry (CD8)
Time frame: Baseline through week 52
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jul 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Alvin J. Siteman Cancer Center at Barnes-Jewish Hospital and Washington University School of MedicineLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
William E Gillanders, M.D. principal investigator
Washington University School of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Neoantigen Peptide Vaccine, Poly ICLC and Blood for immune monitoring in people with Pancreas Cancer and Pancreatic Cancer, run by Washington University School of Medicine at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 17 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 17 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 31 May 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety of Neoantigen Peptide Vaccine as Measured by the Number of Serious Adverse Events (time frame: Through 30 days following completion of treatment (median follow-up of 107 days, full range of 88-157 days)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Jul 2024.