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Immunotherapy + Vaccine for Liver Cancer

Phase 1 & 2

Recruiting

Led By Lewis R. Roberts, M.D., Ph.D.

Research Sponsored by Mayo Clinic

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

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

Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0 or 1

Must not have

Barcelona Clinic Liver Cancer (BCLC) stage D disease

Child Pugh class B or C cirrhosis of the liver

Timeline

Screening 3 weeks

Treatment Varies

Follow Up from registration to death from any cause, assessed up to 5 years after registration

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing a new cancer treatment that uses the patient's own immune cells to fight the cancer.

Who is the study for?

This trial is for adults with liver cancer that can't be removed by surgery. They must have a certain level of white blood cells, kidney function, and liver function, and not be pregnant or nursing. People with other active cancers, recent major surgeries, severe allergies to vaccines, HIV on antiretroviral therapy, serious illnesses that could affect the study results or who are taking certain medications are excluded.

What is being tested?

The trial tests if modified immune cells (autologous dendritic cells) from patients' own blood can stimulate the immune system to fight liver cancer when given after high-dose radiation therapy. It also examines whether adding Prevnar vaccine enhances this effect. The safety and effectiveness of combining these treatments with immune checkpoint inhibitors will be studied in two phases for different types of liver cancer.

What are the potential side effects?

Possible side effects include reactions at the injection site where modified immune cells are administered, flu-like symptoms due to immune response stimulation by the vaccine and treatment-related inflammation affecting various organs due to checkpoint inhibitors.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My liver cancer has been confirmed by tests and scans.

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I am fully active or restricted in physically strenuous activity but can do light work.

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My cancer is confirmed as intrahepatic cholangiocarcinoma.

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My scans show no cancer outside the liver.

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My cancer can be measured or seen on tests.

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My liver cancer cannot be removed by surgery.

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All my cancer lesions can be targeted with external beam radiation without harming healthy tissues.

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My tumor can be reached with a needle for treatment under ultrasound guidance.

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I am 18 years old or older.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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My liver cancer is in the most advanced stage.

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My liver disease is moderately to severely advanced.

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I have not had major surgery within the last 4 weeks, except for diagnostic procedures or to prepare for radiation.

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I have an active autoimmune disease like rheumatoid arthritis or lupus.

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I have had treatments that boost the immune system, like drugs targeting PD-1 or CTLA4.

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I need treatment for blood clotting issues or take blood thinners that can't be stopped for a cancer injection procedure.

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I haven't taken any form of corticosteroids in the last 2 weeks.

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I do not have any serious illnesses or social situations that would stop me from following the study's requirements.

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I have had a heart attack in the last 6 months or have heart failure needing constant treatment.

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I am immunocompromised or HIV positive and on antiretroviral therapy.

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I have had radiation treatment for my liver.

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I have untreated high-risk varices in my stomach or esophagus.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ from registration to the first of either disease progression or death from any cause, assessed up to 5 years after registration

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~from registration to the first of either disease progression or death from any cause, assessed up to 5 years after registration

This trial's timeline: 3 weeks for screening, Varies for treatment, and from registration to the first of either disease progression or death from any cause, assessed up to 5 years after registration for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Incidence of significant toxicity (Pilot study)

Secondary study objectives

Clinical benefit rate

Duration of response

Number of patients who received at least one dose of intratumoral DC injection

+4 more

Other study objectives

Change in immunologic correlates before and after vaccination treatment

Change in target lesion measurements

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Group I: Pilot study (pheresis, EBRT, dendritic cells, Prevnar)Experimental Treatment4 Interventions

Patients with unresectable intrahepatic CCA undergo apheresis for dendric cell manufacturing and standard of care high-dose EBRT for 5 or 15 fractions over 1-3 weeks (cycle 1). Patients then receive autologous dendritic cells IT on day 1 of cycles 2-8 and pneumococcal 13-valent conjugate vaccine IM on day 1 of cycles 2-4 only. Treatment repeats every 28 days for up to 7 cycles in the absence of disease progression or unacceptable toxicity.

Group II: Phase II(pheresis, EBRT, dendritic cells, Prevnar, atezo, bev)Experimental Treatment6 Interventions

Patients with unresectable HCC undergo apheresis for dendric cell manufacturing and standard of care high-dose EBRT for 5 or 15 fractions over 1-3 weeks (cycle 1). Patients then receive autologous dendritic cells IT on day 1 of cycles 2-8 and pneumococcal 13-valent conjugate vaccine IM on day 1 of cycles 2-4 only. Patients also receive standard of care atezolizumab IV and bevacizumab IV starting on day 2 of cycles 2-8. Treatment repeats every 21 days for up to 7 cycles in the absence of disease progression or unacceptable toxicity.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Pheresis

2017

Completed Phase 2

~10

Bevacizumab

2013

Completed Phase 4

~5540