Personalized Peptide Vaccine in Treating Patients With Advanced Pancreatic Cancer or Colorectal Cancer

StatusActive, Not Recruiting
PhasePhase 1
Started

Free. We email you which fields changed when ClinicalTrials.gov updates this record.

Track this trial
View on ClinicalTrials.gov ↗

Record History

See every version on ClinicalTrials.gov ↗

  1. Trial status changed: Enrolling by Invitation → Active, Not Recruiting
    • Final enrollment: 119 participants (planned 300)
    • Eligibility criteria expanded, about 24 words
    • Secondary endpoints: details revised at 2 of 12 entries
  2. Trial status changed: Recruiting → Enrolling by Invitation
    • Site details revised
    v40
  3. Re-verified, no change to tracked fieldsv39
  4. Trial status changed: Active, Not Recruiting → Recruiting
    • Enrollment increased: 117 → 300 participants
    • Site details revised
    v38
  5. Trial status: Enrolling by Invitation to Active, Not Recruiting
    • Enrollment target: estimated 150 to confirmed 117
    v37
Show 35 earlier versionsHide 35 earlier versions
  1. 3 versions Re-verified since Aug 11, 2025, no change to tracked fieldsv34-v36
  2. Primary and study completion dates: May 31, 2025 to May 31, 2027
    • Trial status: Recruiting to Enrolling by Invitation
    • Eligibility criteria shortened, about 798 words
    • Site details revised
    v33
  3. 5 versions Re-verified since Sep 6, 2023, no change to tracked fieldsv28-v32
  4. Primary endpoints revised (3)v27 Show 4 more changesShow less
    • Interventions: Imiquimod (Drug), Pembrolizumab (Biological), Sotigalimab (Biological), Synthetic Tumor-Associated Peptide Vaccine Therapy (Biological) to Computed Tomography (Procedure), Imiquimod (Drug), Magnetic Resonance Imaging (Procedure), Pembrolizumab (Biological), Sotigalimab…
    • Eligibility criteria expanded, about 54 words
    • Secondary endpoints revised (12)
    • Study description expanded, about 78 words
  5. Primary and study completion dates: May 31, 2022 to May 31, 2025v26
  6. Enrollment target: 60 to 150v25 Show 7 more changesShow less
    • Primary endpoints revised (3)
    • Interventions: Imiquimod (Drug), Laboratory Biomarker Analysis (Other), Pembrolizumab (Biological), Synthetic Tumor-Associated Peptide Vaccine Therapy… to Imiquimod (Drug), Pembrolizumab (Biological), Sotigalimab (Biological), Synthetic Tumor-Associated Peptide Vaccine Therapy (Biological)
    • Eligibility criteria expanded, about 239 words
    • Secondary endpoints: 5 to 12
    • Study description expanded, about 215 words
    • Site contact updated
    • Study arms: 1 to 3
  7. Primary and study completion dates: May 31, 2021 to May 31, 2022v24
  8. 2 versions Re-verified since Sep 18, 2020, no change to tracked fieldsv22-v23
  9. Trial status: Active, Not Recruiting to Recruiting
    • Site details revised
    v21
  10. Secondary endpoints: details revised at 2 of 5 entriesv20
  11. Re-verified, no change to tracked fieldsv19
  12. Enrollment target: 29 to 60v18 Show 9 more changesShow less
    • Primary endpoints: 2 to 3
    • Interventions: Pembrolizumab (Drug), Peptide Vaccine (Biological), Phone Call (Behavioral) to Imiquimod (Drug), Laboratory Biomarker Analysis (Other), Pembrolizumab (Biological), Synthetic Tumor-Associated Peptide Vaccine Therapy…
    • Eligibility criteria shortened, about 74 words
    • Secondary endpoints: 1 to 5
    • Study description shortened, about 606 words
    • Study site revised
    • Study arms: 2 to 1
    • Collaborators expanded, about 4 words
    • Study title expanded, about 3 words
  13. Primary and study completion dates: May 2021 to May 31, 2021v17
  14. Trial status: Recruiting to Active, Not Recruitingv16 Show 4 more changesShow less
    • Enrollment target: estimated 60 to confirmed 29
    • Study completion date: May 2022 to May 2021
    • Start date: May 2016 to May 11, 2016
    • Site details revised
  15. Re-verified, no change to tracked fieldsv15
  16. Study completion date: May 2021 to May 2022
    • Study description shortened, about 89 words
    v14
  17. Trial status: Enrolling by Invitation to Recruiting
    • Site details revised
    v13
  18. 2 versions Re-verified since Aug 16, 2017, no change to tracked fieldsv11-v12
  19. Enrollment target: 40 to 60v10 Show 4 more changesShow less
    • Interventions: Peptide Vaccine (Biological), Phone Call (Behavioral) to Pembrolizumab (Drug), Peptide Vaccine (Biological), Phone Call (Behavioral)
    • Eligibility criteria expanded, about 157 words
    • Study description expanded, about 138 words
    • Study arms: 1 to 2
  20. Study completion date: May 2021v9
  21. 2 versions Re-verified since Sep 2, 2016, no change to tracked fieldsv7-v8
  22. Eligibility criteria shortened, about 99 words
    • Study description expanded, about 53 words
    v6
  23. Trial status: Recruiting to Enrolling by Invitation
    • Site details revised
    v5
  24. Trial status: Not Yet Recruiting to Recruitingv4 Show 4 more changesShow less
    • Primary completion date: Jul 2021 to May 2021
    • Start date: Jul 2016 to May 2016
    • Eligibility criteria expanded, about 6 words
    • Site details revised
  25. Start date: Mar 2016 to Jul 2016
    • Primary completion date: Mar 2021 to Jul 2021
    v3
  26. Study description revisedv2
  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 I trial studies the side effects and best way to give personalized peptide vaccine in patients with pancreatic or colorectal cancer that has spread to other places in the body and usually cannot be cured or controlled with treatment (advanced). Personalized peptide vaccine is a vaccine developed from patient's own tumor cells and blood in order to use as a biological therapy. Biological therapies, such as personalized peptide vaccine may attack tumor cells and stop them from growing or kill them.
Trial Details
NCT Number NCT02600949
Lead Sponsor M.D. Anderson Cancer Center
Collaborators: National Cancer Institute (NCI)
Conditions
(from sponsor)		 Metastatic Colorectal Adenocarcinoma, Metastatic Pancreatic Ductal Adenocarcinoma, Stage IV Colorectal Cancer AJCC v7, Stage IV Pancreatic Cancer AJCC v6 and v7, Stage IVA Colorectal Cancer AJCC v7, Stage IVB Colorectal Cancer AJCC v7
Related terms Colorectal Neoplasms
Enrollment 119 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov