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
Eligible age
18+ yrs
Accepts
All genders
Locations
1 state
Healthy volunteers
No
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About this study
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.
Sponsor: Mayo Clinic
You may qualify if…
- ✓ 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)
- ✓ The following tumor characteristics must be met
- ✓ Unresectable disease: HCC (group 2) or intrahepatic CCA (group 3)
- ✓ Measurable or evaluable disease
- ✓ All lesions should be treatable by EBRT while meeting normal tissue constraints
You may not qualify if…
- ✕ Any of the following because this study involves an investigational agent, the genotoxic, mutagenic and teratogenic effects of which on the developing fetus and newborn are unknown:
- ✕ 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
- ✕ Immunocompromised patients and patients known to be HIV positive.
- ✕ NOTE: Patients known to be HIV positive, but without clinical evidence of an immunocompromised state, are eligible for this trial if they are stable on anti-retroviral therapy, have a CD4+ T cell count ≥ 200/uL, and have an undetectable viral load
- ✕ Uncontrolled intercurrent illness including, but not limited to:
Where it's recruiting
Rochester
Source: ClinicalTrials.gov · NCT03942328 · last updated 2026-04-20