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Neoantigen Vaccine for Pancreatic Cancer

Phase 1
Waitlist Available
Led By William E Gillanders, M.D.
Research Sponsored by Washington University School of Medicine
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Histologically or cytologically confirmed, newly diagnosed, treatment-naïve patients with localized or borderline resectable adenocarcinoma of the pancreas for whom neoadjuvant chemotherapy is considered appropriate; mixed histology (including adenosquamous)
Adequate bone marrow and organ function as defined below: WBC ≥ 1.5 K/cumm, absolute neutrophil count ≥ 1.0 K/cumm, platelets ≥ 50 K/cumm, hemoglobin ≥ 8.0 g/dL, total bilirubin ≤ 5.0 X institutional upper limit of normal, AST/ALT ≤ 5.0 X institutional upper limit of normal, creatinine ≤2.5 X institutional upper limit of normal OR creatinine clearance ≥ 30 mL/min by Cockcroft-Gault for patients with creatinine levels above institutional normal
Timeline
Screening 3 weeks
Treatment Varies
Follow Up through 4 weeks after completion of last vaccination (estimated to be 108 days)
Awards & highlights

Study Summary

This trial is evaluating the safety of neoantigen vaccines in pancreatic cancer patients.

Who is the study for?
Adults with newly diagnosed, treatable pancreatic adenocarcinoma who are set for neoadjuvant chemotherapy and surgery. They must have a life expectancy over 12 months, good organ function, and agree to use two forms of contraception. Excluded are those with other cancers within the last 3 years (except certain skin cancers), known allergies to vaccines, HIV or hepatitis B/C infections, autoimmune diseases requiring immunosuppression, or any condition that limits study compliance.Check my eligibility
What is being tested?
This trial tests an optimized neoantigen synthetic long peptide vaccine given alongside poly-ICLC in patients with pancreatic cancer. Participants will be randomly assigned to receive this vaccine either after neoadjuvant chemotherapy but before surgery (Arm 2) or following both chemo and surgery (Arm 1).See study design
What are the potential side effects?
Potential side effects may include typical vaccine reactions like soreness at the injection site, allergic responses such as hives or difficulty breathing although serious reactions are rare. Since it's a phase I trial primarily assessing safety, close monitoring for any unexpected side effects is part of the process.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I have a new diagnosis of pancreatic cancer that hasn't been treated yet.
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My blood tests show normal organ function and I don't have severe anemia or liver/kidney issues.
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I am fully active and can carry on all my pre-disease activities without restriction.
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I am 18 years old or older.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~through 4 weeks after completion of last vaccination (estimated to be 108 days)
This trial's timeline: 3 weeks for screening, Varies for treatment, and through 4 weeks after completion of last vaccination (estimated to be 108 days) for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Safety of neoantigen SLP vaccine as measured by number of subjects experiencing each type of adverse event
Secondary outcome measures
Immunogenicity of neoantigen peptide vaccine as measured by the phenotype of neoantigen-specific T cells (only Arm 1 and Arm 2)
Immunogenicity of neoantigen peptide vaccine as measured by the the number of neoantigen-specific T cells (only Arm 1 and Arm 2)

Side effects data

From 2022 Phase 1 & 2 trial • 58 Patients • NCT02643303
60%
Constipation
60%
Anaemia
40%
Diarrhoea
40%
Fatigue
40%
Injection site pain
40%
Anxiety
20%
Tachycardia
20%
Aspartate aminotransferase increased
20%
Hypercalcaemia
20%
Blood pressure increased
20%
Troponin increased
20%
Puncture site haemorrhage
20%
Acute kidney injury
20%
Dry skin
20%
Hyperkalaemia
20%
Eyelid ptosis
20%
Ascites
20%
Excess cerumen production
20%
Myasthenia gravis
20%
Erythema
20%
Pruritus generalized
20%
Injection site reaction
20%
Puncture site pain
20%
Alanine aminotransferase increased
20%
Hyponatraemia
20%
Myositis
20%
Neoplasm progression
20%
Pleural effusion
20%
Myocarditis
20%
Hypothyroidism
20%
Nausea
20%
Chapped lips
20%
Oedema peripheral
20%
Weight decreased
20%
Blood creatinine increased
20%
Decreased appetite
20%
Hypomagnesaemia
20%
Pain in extremity
20%
Arthralgia
20%
Back pain
20%
Dizziness
20%
Rash
20%
Hypotension
20%
Deep vein thrombosis
20%
Atrial flutter
100%
80%
60%
40%
20%
0%
Study treatment Arm
Phase 1, Cohort 1B
Cohort 1C + Phase 2; Head + Neck Squamous Cell Carcinoma
Cohort 1C + Phase 2; Sarcoma
Cohort 1C + Phase 2; Locally Recurrent or Metastatic Breast Cancer
Cohort 1C + Phase 2; Solid Tumors With Accessible Masses
Cohort 1C + Phase 2; Melanoma After Failure of Available Therapies
Cohort 1C + Phase 2; Genitourinary Cancers With Accessible Metastases
Cohort 1C + Phase 2; Merkel Cell Carcinoma
Phase 1, Cohort 1A

Trial Design

2Treatment groups
Experimental Treatment
Group I: Arm 2: Vaccine given after neoadjuvant chemotherapy but before surgeryExperimental Treatment2 Interventions
The neoantigen peptide vaccine will be manufactured during neoadjuvant chemotherapy. Institutional standard of care chemotherapy will be given. Peptide and poly-ICLC will be administered intramuscularly on Days 1, 4, 8, 15, and 22 during the chemotherapy holiday, and Days 50 and 78 post-operatively. Optimal timing for Day 1 is 1 week after end of chemotherapy, but Day 1 may be given up to 3 weeks after end of chemotherapy.
Group II: Arm 1: Vaccine given after neoadjuvant chemotherapy and surgeryExperimental Treatment2 Interventions
The neoantigen peptide vaccine will be manufactured during neoadjuvant chemotherapy. Institutional standard of care chemotherapy will be given. Peptide and poly-ICLC will be administered intramuscularly on Days 1, 4, 8, 15, 22, 50, and 78 beginning approximately 1 month after surgery. Day 1 should begin approximately 1 month after surgery.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Poly-ICLC
2016
Completed Phase 2
~240

Find a Location

Who is running the clinical trial?

Washington University School of MedicineLead Sponsor
1,931 Previous Clinical Trials
2,299,684 Total Patients Enrolled
National Cancer Institute (NCI)NIH
13,654 Previous Clinical Trials
40,933,128 Total Patients Enrolled
LeidosUNKNOWN

Media Library

Poly-ICLC Clinical Trial Eligibility Overview. Trial Name: NCT05111353 — Phase 1
Pancreatic Cancer Research Study Groups: Arm 1: Vaccine given after neoadjuvant chemotherapy and surgery, Arm 2: Vaccine given after neoadjuvant chemotherapy but before surgery
Pancreatic Cancer Clinical Trial 2023: Poly-ICLC Highlights & Side Effects. Trial Name: NCT05111353 — Phase 1
Poly-ICLC 2023 Treatment Timeline for Medical Study. Trial Name: NCT05111353 — Phase 1

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is it safe to administer a Neoantigen synthetic long peptide vaccine for patients?

"Considering the fact that this is an early-stage Phase 1 study, our team at Power assigned Neoantigen synthetic long peptide vaccine a safety rating of 1 due to limited evidence supporting its efficacy and safety."

Answered by AI

Are there any available openings to join this clinical experiment?

"This clinical trial is actively recruiting participants, as evidenced by the information provided on clinicaltrials.gov. The study was initially published on October 10th 2022 and has since been modified when it was last updated a month later."

Answered by AI

How many people are actively participating in this investigation?

"Affirmative. According to the clinicaltrials.gov website, this medical experiment is presently accepting participants since its inception on October 10th 2022 and latest update on November 10th 2022. The research team need 30 individuals at 1 location for their investigation."

Answered by AI

What objectives is this experiment aiming to accomplish?

"The primary objective of this research is to analyze the safety of a neoantigen vaccine, as measured by adverse events over 30 days post-vaccination (108 days estimated). Secondary objectives include evaluating the immunogenicity of said vaccine through assessing the phenotype and number of neoantigen-specific T cells at various points in time such as baseline, surgery day, 1st day after vaccination, 15th day after vaccination, 22nd day after vaccination and 78th day post-vaccination. Optional monitoring may also occur one year and two years following last administered dose."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
Neoantigen Vaccines in Pancreatic Cancer in the Window Prior to Surgery
2022. "Neoantigen Vaccines in Pancreatic Cancer in the Window Prior to Surgery". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05111353.
~14 spots leftby Dec 2025
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