Mutant KRAS -Targeted Long Peptide Vaccine for Patients at High Risk of Developing Pancreatic Cancer

StatusActive, Not Recruiting
PhasePhase 1
Started

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Record History

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  1. Enrollment closed, study ongoing
    • Final enrollment: 31 participants (planned 37)
    • Eligibility criteria expanded, about 32 words
    • Site details revised
  2. Re-verified, no change to tracked fieldsv14
  3. Site contact updatedv13
  4. Primary completion date: May 1, 2026 to Oct 1, 2027
    • Study completion date: May 1, 2026 to May 1, 2031
    v12
  5. Collaborators: 1 to 2v11
Show 9 earlier versionsHide 9 earlier versions
  1. Eligibility criteria expanded, about 56 words
    • Secondary endpoints: details revised at 3 of 3 entries
    • Site contact updated
    v10
  2. Enrollment target: 25 to 37v9 Show 4 more changesShow less
    • Interventions: KRAS peptide vaccine (Drug) to Cohort A: Patients at high risk of developing pancreatic cancer. (Drug), Cohort B: Patients must have evidence of a pancreatic cystic…
    • Study description expanded, about 133 words
    • Site contact updated
    • Study arms: 1 to 2
  3. 2 versions Re-verified since Mar 6, 2023, no change to tracked fieldsv7-v8
  4. Secondary endpoints: 1 to 3v6
  5. Trial status: Not Yet Recruiting to Recruitingv5 Show 6 more changesShow less
    • Primary endpoints: 3 to 2
    • Start date changed from estimate of May 2022 to Apr 11, 2022
    • Eligibility criteria expanded, about 109 words
    • Secondary endpoints: 2 to 1
    • Site details revised
    • Study title shortened, about 3 words
  6. Site contact updatedv4
  7. Start date: Mar 2022 to May 2022
    • Primary and study completion dates: Mar 1, 2026 to May 1, 2026
    v3
  8. Start date: Dec 2021 to Mar 2022
    • Primary and study completion dates: Dec 1, 2025 to Mar 1, 2026
    v2
  1. Study First Submitted
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
This Phase 1 study will evaluate safety and the immune response to pooled mutant-KRAS peptide vaccine with poly-ICLC adjuvant for patients who have been identified to be at risk of developing pancreatic cancer.
Trial Details
NCT Number NCT05013216
Lead Sponsor Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Collaborators: Stand Up To Cancer, National Cancer Institute (NCI)
Conditions
(from sponsor)		 High Risk Cancer, Pancreatic Cancer
Related terms Pancreatic Neoplasms
Enrollment 31 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov