RecruitingPhase 1Phase 2NCT03942328

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

MC1641 Phase II Study Of Intratumoral Injection Of Autologous Dendritic Cells Combined With Immune Checkpoint Inhibition After High-Dose Conformal External Beam Radiotherapy In Patients With Unresectable Primary Liver Cancer


Sponsor

Mayo Clinic

Enrollment

85 participants

Start Date

Sep 19, 2019

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a combination treatment for liver cancer that uses high-dose radiation followed by a personalized immune therapy made from your own immune cells (dendritic cells), combined with a vaccine and an immune checkpoint drug (a type of immunotherapy). The goal is to "wake up" the immune system to attack the liver tumor. **You may be eligible if...** - You are at least 18 years old - You have a confirmed diagnosis of hepatocellular carcinoma (the most common type of liver cancer) or intrahepatic cholangiocarcinoma (bile duct cancer in the liver) or liver metastases from colorectal cancer - Your tumor cannot be surgically removed - Your liver function is adequate **You may NOT be eligible if...** - You have severe liver dysfunction or active hepatitis - You have an autoimmune disease that would worsen with immunotherapy - You have active uncontrolled infections - You are pregnant or breastfeeding - You have cancer that has spread widely beyond the liver Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

BIOLOGICALAtezolizumab

Given IV

BIOLOGICALBevacizumab

Given IV

RADIATIONExternal Beam Radiation Therapy

Undergo high-dose EBRT

PROCEDUREPheresis

Undergo apheresis

BIOLOGICALPneumococcal 13-valent Conjugate Vaccine

Given IM

BIOLOGICALTherapeutic Autologous Dendritic Cells

Given IT

BIOLOGICALDurvalumab

Given IV

PROCEDUREEsophagogastroduodenoscopy

Undergo EGD

PROCEDUREComputed Tomography

Undergo CT or PET/CT

PROCEDUREPositron Emission Tomography

Undergo PET/CT

PROCEDUREMagnetic Resonance Imaging

Undergo MRI

PROCEDUREBiopsy Procedure

Undergo biopsy

PROCEDUREBiospecimen Collection

Undergo urine and blood sample collection


Locations(1)

Mayo Clinic in Rochester

Rochester, Minnesota, United States

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NCT03942328


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