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
Mayo Clinic
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.
Description
PRIMARY OBJECTIVE: I. Evaluation of safety and tolerability of an autologous dendritic cell (DC) vaccine delivered by intra-tumoral injection in patients with primary liver cancer treated with high-dose conformal external beam radiotherapy (EBRT). (Pilot Study) II. Estimate the progression-free survival rate at 2 years post-registration to see if treatment is efficacious compared to historical data in hepatocellular carcinoma (HCC). (Phase II Group 2) II. Estimate the progression-free survival to see if treatment is efficacious compared to historical data in intrahepatic cholangiocarcinoma (i…
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: * 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 * Tumor lesions should…
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
Location
- Mayo Clinic in RochesterRochester, Minnesota