Clinical trialPhase 1Active not recruiting
Neoantigen Vaccines in Pancreatic Cancer in the Window Prior to Surgery
- Outcome
- Ongoing
- Phase
- Phase 1
- Status
- Active not recruiting
- Study type
- Interventional
- Start
- 15 December 2022
- Expected end
- 6 October 2027
- Enrollment
- 33 participants
- Sites
- 1
- Primary outcomes
- Safety of Neoantigen SLP Vaccine as Measured by Number of Subjects Experiencing Each Type of Adverse Event
- Sponsor
- Other
- Results posted
- 2026-11-03
- Last update
- 3 November 2026
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Brief summary public domain (ClinicalTrials.gov)
This is a randomized phase 1 clinical trial to evaluate the safety of an optimized neoantigen synthetic long peptide (SLP) vaccines in pancreatic cancer patients following neoadjuvant chemotherapy. The neoantigen SLP vaccines will incorporate prioritized neoantigens and will be co-administered with poly-ICLC. Patients will be randomized to one of two arms: Arm 1 (neoantigen vaccine following neoadjuvant chemotherapy and surgery) or Arm 2 (neoantigen vaccine following neoadjuvant chemotherapy in the window prior to surgery). Those who are ineligible for vaccine administration including those whose disease progresses or recurs during neoadjuvant chemo or who are otherwise unable to complete surgical resection but who had a personalized neoantigen vaccine manufactured, or significant progress has been made as determined by treating physician, are permitted to receive vaccine injections on study.
Posted results (ClinicalTrials.gov registry) · primary outcome public domain (ClinicalTrials.gov)
Safety of Neoantigen SLP Vaccine as Measured by Number of Subjects Experiencing Each Type of Adverse Event [Through 4 weeks after completion of last vaccination (estimated to be 108 days)]. Count Of Participants, Participants. Grade 1/2 anemia: Arm 1: Vaccine Given After Neoadjuvant Chemotherapy and Surgery (n=10): 2; Arm 2: Vaccine Given After Neoadjuvant Chemotherapy But Before Surgery (n=9): 4. Grade 3/4/5 anemia: Arm 1: Vaccine Given After Neoadjuvant Chemotherapy and Surgery (n=10): 1; Arm 2: Vaccine Given After Neoadjuvant Chemotherapy But Before Surgery (n=9): 2. Grade 1/2 eosinophilia: Arm 1: Vaccine Given After Neoadjuvant Chemotherapy and Surgery (n=10): 0; Arm 2: Vaccine Given After Neoadjuvant Chemotherapy But Before Surgery (n=9): 1. Grade 3/4/5 myocardial infarction: Arm 1: Vaccine Given After Neoadjuvant Chemotherapy and Surgery (n=10): 1; Arm 2: Vaccine Given After Neoadjuvant Chemotherapy But Before Surgery (n=9): 0. Grade 1/2 double vision: Arm 1: Vaccine Given After Neoadjuvant Chemotherapy and Surgery (n=10): 1; Arm 2: Vaccine Given After Neoadjuvant Chemotherapy But Before Surgery (n=9): 0. Grade 1/2 abdominal cramping: Arm 1: Vaccine Given After Neoadjuvant Chemotherapy and Surgery (n=10): 0; Arm 2: Vaccine Given After Neoadjuvant Chemotherapy But Before Surgery (n=9): 1. Grade 1/2 abdominal pain: Arm 1: Vaccine Given After Neoadjuvant Chemotherapy and Surgery (n=10): 2; Arm 2: Vaccine Given After Neoadjuvant Chemotherapy But Before Surgery (n=9): 3. Grade 1/2 colitis: Arm 1: Vaccine Given After Neoadjuvant Chemotherapy and Surgery (n=10): 1; Arm 2: Vaccine Given After Neoadjuvant Chemotherapy But Before Surgery (n=9): 0. Grade 1/2 constipation: Arm 1: Vaccine Given After Neoadjuvant Chemotherapy and Surgery (n=10): 1; Arm 2: Vaccine Given After Neoadjuvant Chemotherapy But Before Surgery (n=9): 0. Grade 1/2 diarrhea: Arm 1: Vaccine Given After Neoadjuvant Chemotherapy and Surgery (n=10): 2; Arm 2: Vaccine Given After Neoadjuvant Chemotherapy But Before Surgery (n=9): 1. Grade 1/2 dyspepsia: Arm 1: Vaccine Given After Neoadjuvant Chemotherapy and Surgery (n=10): 1; Arm 2: Vaccine Given After Neoadjuvant Chemotherapy But Before Surgery (n=9): 0. Grade 1/2 gastroparesis: Arm 1: Vaccine Given After Neoadjuvant Chemotherapy and Surgery (n=10): 0; Arm 2: Vaccine Given After Neoadjuvant Chemotherapy But Before Surgery (n=9): 1. Grade 1/2 mouth sore: Arm 1: Vaccine Given After Neoadjuvant Chemotherapy and Surgery (n=10): 0; Arm 2: Vaccine Given After Neoadjuvant Chemotherapy But Before Surgery (n=9): 1. Grade 1/2 mucositis oral: Arm 1: Vaccine Given After Neoadjuvant Chemotherapy and Surgery (n=10): 3; Arm 2: Vaccine Given After Neoadjuvant Chemotherapy But Before Surgery (n=9): 0. Grade 1/2 nausea: Arm 1: Vaccine Given After Neoadjuvant Chemotherapy and Surgery (n=10): 4; Arm 2: Vaccine Given After Neoadjuvant Chemotherapy But Before Surgery (n=9): 5. Grade 1/2 vomiting: Arm 1: Vaccine Given After Neoadjuvant Chemotherapy and Surg