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Modified Immune Cells (Autologous Dendritic Cells) and a Vaccine (Prevnar) Combined With Immune Checkpoint Inhibition After High-Dose External Beam Radiation Therapy in Treating Patients With Unresectable Liver Cancer

StatusRecruiting
PhasePhase 1/2
Started
View on ClinicalTrials.gov ↗
Trial flagged as At Risk
Primary completion moved at least 3 months later May 31, 2030 → Aug 31, 2030
See other at-risk trials from Mayo Clinic

Record History

  1. Primary completion pushed from May 31, 2030 to Aug 31, 2030 Completion moved earlier from Feb 28, 2031 to Aug 31, 2030 · Eligibility criteria expanded, about 9 words · Secondary endpoints: details revised at 4 of 7 entries · 1 more Show 4 more changesShow less
    • Completion moved earlier from Feb 28, 2031 to Aug 31, 2030
    • Eligibility criteria expanded, about 9 words
    • Secondary endpoints: details revised at 4 of 7 entries
    • Study description revised
  2. Primary completion pushed from Aug 31, 2029 to May 31, 2030 Completion pushed from Aug 31, 2029 to Feb 28, 2031v26 Show 1 more changeShow less
    • Completion pushed from Aug 31, 2029 to Feb 28, 2031
  3. Primary completion pushed from Aug 31, 2027 to Aug 31, 2029 Completion pushed from Feb 29, 2028 to Aug 31, 2029 · Site contact updatedv25 Show 2 more changesShow less
    • Completion pushed from Feb 29, 2028 to Aug 31, 2029
    • Site contact updated
  4. Interventions: Atezolizumab (Biological), Bevacizumab (Biological), Biopsy Procedure (Procedure), Biospecimen Collection (Procedure), Computed Tomography… to Atezolizumab (Biological), Bevacizumab (Biological), Biopsy Procedure (Procedure), Biospecimen Collection (Procedure), Computed Tomography… Eligibility criteria shortened, about 321 words · Study description shortened, about 3 wordsv24 Show 2 more changesShow less
    • Eligibility criteria shortened, about 321 words
    • Study description shortened, about 3 words

    See this version in full on ClinicalTrials.gov ↗

  5. Enrollment target: 54 to 85 Primary endpoints: 2 to 3 · Interventions: Atezolizumab (Biological), Bevacizumab (Biological), External Beam Radiation Therapy (Radiation), Pheresis (Procedure), Pneumococcal… to Atezolizumab (Biological), Bevacizumab (Biological), Biopsy Procedure (Procedure), Biospecimen Collection (Procedure), Computed Tomography… · Eligibility criteria expanded, about 882 words · 4 morev23 Show 7 more changesShow less
    • Primary endpoints: 2 to 3
    • Interventions: Atezolizumab (Biological), Bevacizumab (Biological), External Beam Radiation Therapy (Radiation), Pheresis (Procedure), Pneumococcal… to Atezolizumab (Biological), Bevacizumab (Biological), Biopsy Procedure (Procedure), Biospecimen Collection (Procedure), Computed Tomography…
    • Eligibility criteria expanded, about 882 words
    • Secondary endpoints: details revised at 2 of 7 entries
    • Study description expanded, about 251 words
    • Study arms: 2 to 3
    • Study title expanded, about 5 words

    See this version in full on ClinicalTrials.gov ↗

Show 21 earlier versionsHide 21 earlier versions
  1. Re-verified, no change to tracked fieldsv22
  2. Site contact updatedv21
  3. Re-verified, no change to tracked fieldsv20
  4. Start date: Feb 28, 2023 to Sep 19, 2019v19
  5. Phase: Phase 2 to Phase 1/2 Study description expanded, about 19 words · Site contact updatedv18 Show 2 more changesShow less
    • Study description expanded, about 19 words
    • Site contact updated

    See this version in full on ClinicalTrials.gov ↗

  6. 2 versions Re-verified since Jul 17, 2023, no change to tracked fieldsv16-v17
  7. Primary completion date: Dec 31, 2026 to Aug 31, 2027 Start date: Jun 11, 2019 to Feb 28, 2023 · Completion date: Dec 31, 2026 to Feb 29, 2028v15 Show 2 more changesShow less
    • Start date: Jun 11, 2019 to Feb 28, 2023
    • Completion date: Dec 31, 2026 to Feb 29, 2028
  8. Primary and study completion dates: Dec 15, 2023 to Dec 31, 2026v14
  9. Phase: Early Phase 1 to Phase 2 Enrollment target: 26 to 54 · Primary endpoints: 1 to 2 · Start date: Jun 17, 2019 to Jun 11, 2019 · 5 morev13 Show 8 more changesShow less
    • Enrollment target: 26 to 54
    • Primary endpoints: 1 to 2
    • Start date: Jun 17, 2019 to Jun 11, 2019
    • Interventions: External Beam Radiation Therapy (Radiation), Pneumococcal 13-valent Conjugate Vaccine (Biological), Therapeutic Autologous Dendritic Cells… to Atezolizumab (Biological), Bevacizumab (Biological), External Beam Radiation Therapy (Radiation), Pheresis (Procedure), Pneumococcal…
    • Eligibility criteria expanded, about 81 words
    • Study description expanded, about 136 words
    • Site contact updated
    • Study arms: 1 to 2

    See this version in full on ClinicalTrials.gov ↗

  10. Primary and study completion dates: May 1, 2023 to Dec 15, 2023v12
  11. Site contact updatedv11
  12. Start date: May 17, 2019 to Jun 17, 2019v10
  13. Primary and study completion dates: May 1, 2022 to May 1, 2023v9
  14. Re-verified, no change to tracked fieldsv8
  15. Secondary endpoints: details revised at 2 of 7 entries Study description revised · Study site revised · Eligibility criteria shortened, about 1 wordv7 Show 3 more changesShow less
    • Study description revised
    • Study site revised
    • Eligibility criteria shortened, about 1 word

    See this version in full on ClinicalTrials.gov ↗

  16. Re-verified, no change to tracked fieldsv6
  17. Trial status: Suspended to Recruiting Site details revisedv5 Show 1 more changeShow less
    • Site details revised
  18. Trial status: Recruiting to Suspended Sponsor's reason: awaiting completion of BAP processes for study activation Site details revisedv4 Show 1 more changeShow less
    • Site details revised
  19. Trial status: Not Yet Recruiting to Recruiting Start date changed from estimate of Jun 1, 2019 to May 17, 2019 · Site details revisedv3 Show 2 more changesShow less
    • Start date changed from estimate of Jun 1, 2019 to May 17, 2019
    • Site details revised
  20. Start date: May 1, 2019 to Jun 1, 2019v2
  1. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • 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.
Mayo Clinic
1,019 trials monitored
See 121 trials at risk
Liver Cancer
1,512 trials monitored
See 63 trials at risk
Cholangiocarcinoma
614 trials monitored
See 23 trials at risk
This early phase I trial studies the side effects of autologous dendritic cells and a vaccine called Prevnar in combination with immune checkpoint inhibition (with bevacizumab and atezolizumab or druvalumab) in treating patients liver cancer that cannot be removed by surgery (unresectable) after undergoing standard high-dose external beam radiotherapy. Autologous dendritic cells are immune cells generated from patients' own white blood cells that are grown in a special lab and trained to stimulate the immune system to destroy tumor cells. A pneumonia vaccine called Prevnar may also help stimulate the immune system. Bevacizumab is in a class of medications called antiangiogenic agents. It works by stopping the formation of blood vessels that bring oxygen and nutrients to tumor. This may slow the growth and spread of tumor. Immunotherapy with monoclonal antibodies, such as atezolizumab and durvalumab, may help the body's immune system attack the tumor, and may interfere with the ability of tumor cells to grow and spread. Giving autologous dendritic cells and Prevnar in combination with immune checkpoint inhibition after radiotherapy may be safe, and tolerable and may stimulate the body's own immune system to fight against the tumor in patients with unresectable liver cancer.
Trial Details
NCT Number NCT03942328
Lead Sponsor Mayo Clinic
Collaborators: National Cancer Institute (NCI)
Conditions Stage III Hepatocellular Carcinoma AJCC v8, Stage III Intrahepatic Cholangiocarcinoma AJCC v8, Stage IV Hepatocellular Carcinoma AJCC v8, Stage IV Intrahepatic Cholangiocarcinoma AJCC v8, Unresectable Hepatocellular Carcinoma, Unresectable Intrahepatic Cholangiocarcinoma
Enrollment 85 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov