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

Trial statusRecruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorMayo Clinic

About this trial

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.

Eligibility criteria

Qualifiers

Age >= 18 years

Pilot study (group 1): Histologic confirmation of intrahepatic CCA (Closed as of amendment 3)

Phase II study (group 2): Histologic and/or radiologic confirmation of hepatocellular carcinoma (HCC)

Phase II study (group 3): Histologic confirmation of intrahepatic cholangiocarcinoma (iCCA)

Disqualifiers

Pregnant persons

Nursing persons

Persons of childbearing potential who are unwilling to employ highly effective contraception during heterosexual intercourse while on this study and for 5 months after the last dose of study medication

Co-morbid systemic illnesses or other severe concurrent disease which, in the judgment of the investigator, would make the patient inappropriate for entry into this study or interfere significantly with the proper assessment of safety and toxicity of the prescribed regimens

Trial design

Treatments tested in this trial

  • Atezolizumab
  • Bevacizumab
  • External Beam Radiation Therapy
  • Pheresis
  • Pneumococcal 13-valent Conjugate Vaccine
  • Therapeutic Autologous Dendritic Cells
  • Durvalumab
  • Esophagogastroduodenoscopy
  • Computed Tomography
  • Positron Emission Tomography
  • Magnetic Resonance Imaging
  • Biopsy Procedure
  • Biospecimen Collection

Treatment groups

85 Participants
are divided into 3 treatment groups

Sponsors and collaborators

Mayo Clinic

Lead sponsor

National Cancer Institute (NCI)

Collaborator