CompletedPhase 1

Neoantigen Vaccines in Pancreatic Cancer in the Window Prior to Surgery

United States33 participantsStarted 2022-12-15

Plain-language summary

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.

Who can participate

Age range18 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Step 0 Inclusion Criteria (A patient will be eligible for evaluation and sequencing of tissue for vaccine development only if ALL of the following criteria apply:) * 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). Patients with clinical suspicion of pancreatic adenocarcinoma can be enrolled for pre-treatment biopsy, and must be histologically confirmed to have adenocarcinoma before being treated on study. Patients with squamous carcinoma or neuroendocrine tumor will be excluded. * Evaluable disease, in the opinion of the treating investigator or PI. * Tissue specimens available in sufficient quantity to allow for sequencing. * At least 18 years of age. * Life expectancy of \> 12 months. * ECOG performance status ≤ 1 * 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 * Note: labs can be repeated prior to chemo if needed. * Note: Patients who have had…

What they're measuring

Safety of neoantigen SLP vaccine as measured by number of subjects experiencing each type of adverse event

Timeframe: Through 4 weeks after completion of last vaccination (estimated to be 108 days)

Trial details

NCT IDNCT05111353

SponsorWashington University School of Medicine

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2025-11-03