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

Summary

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.

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

Interventions

BIOLOGICAL

Atezolizumab

Given IV

BIOLOGICAL

Bevacizumab

Given IV

RADIATION

External Beam Radiation Therapy

Undergo high-dose EBRT

PROCEDURE

Pheresis

Undergo apheresis

BIOLOGICAL

Pneumococcal 13-valent Conjugate Vaccine

Given IM

BIOLOGICAL

Therapeutic Autologous Dendritic Cells

Given IT

BIOLOGICAL

Durvalumab

Given IV

PROCEDURE

Esophagogastroduodenoscopy

Undergo EGD

PROCEDURE

Computed Tomography

Undergo CT or PET/CT

PROCEDURE

Positron Emission Tomography

Undergo PET/CT

PROCEDURE

Magnetic Resonance Imaging

Undergo MRI

PROCEDURE

Biopsy Procedure

Undergo biopsy

PROCEDURE

Biospecimen Collection

Undergo urine and blood sample collection

Sponsors & Collaborators

• National Cancer Institute (NCI)

  collaborator NIH

• Mayo Clinic

  lead OTHER

Principal Investigators

• Lewis R. Roberts, MD, PhD · Mayo Clinic in Rochester

• Lionel Kankeu Fonkoua, MD · Mayo Clinic in Rochester

Study Design

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

CROSSOVER

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2019-09-19

Primary Completion

2029-08-31

Completion

2029-08-31

FDA Drug

Yes

Countries

• United States

Study Locations