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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

RECRUITING

Clinical Phase

PHASE1/PHASE2

Total Enrollment

85 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-09-19

Study Completion Date

2028-02-29

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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 atezolizumab and tiragolumab) 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 tiragolumab, 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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Atezolizumab and Bevacizumab With Photon Radiotherapy for Unresectable Hepatocellular Carcinoma

NCT06339424

Hepatocellular Carcinoma

RECRUITING PHASE2

Trial of Atezolizumab and Bevacizumab With SRF388 or Placebo in Patients With Hepatocellular Carcinoma

NCT05359861

Hepatocellular Carcinoma

COMPLETED PHASE2

Atezolizumab in Combination With a Multi-Kinase Inhibitor for the Treatment of Unresectable, Locally Advanced, or Metastatic Liver Cancer

NCT05168163

Locally Advanced Hepatocellular Carcinoma Metastatic Hepatocellular Carcinoma Stage III Hepatocellular Carcinoma AJCC v8 +6 more

RECRUITING PHASE2

A Study to Determine Whether Chemotherapy and Atezolizumab is Better Than Chemotherapy, Bevacizumab and Atezolizumab in Patients With Advanced Liver Cancer

NCT05211323

Combined Hepatocellular Carcinoma and Cholangiocarcinoma Stage III Liver Cancer Stage IV Liver Cancer

ACTIVE_NOT_RECRUITING PHASE2

A Study Combining Personalized Neoantigen-based Dendritic Cell Vaccine With Microwave Ablation for the Treatment of Hepatocellular Carcinoma

NCT03674073

Hepatocellular Carcinoma Liver Cancer, Adult

UNKNOWN PHASE1

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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 (iCCA) patients. (Phase II Group 3)

SECONDARY OBJECTIVES:

I. To assess feasibility in patients with liver cancer treated with high-dose conformal EBRT followed by autologous DC vaccine injection by group (Group 1 versus \[vs.\] 2 vs. 3).

II. To assess overall response rate in patients with liver cancer treated with high-dose conformal EBRT followed by autologous DC vaccine injection by group (Group 1 vs. 2 vs. 3).

III. To assess progression free survival in patients with liver cancer treated with high-dose conformal EBRT followed by autologous DC vaccine injection by group (Group 1 vs. 2 vs. 3).

IV. To assess clinical benefit rate in patients with liver cancer treated with high-dose conformal EBRT followed by autologous DC vaccine injection by group (Group 1 vs. 2 vs. 3).

V. To assess time to response in patients with liver cancer treated with high-dose conformal EBRT followed by autologous DC vaccine injection by group (Group 1 vs. 2 vs. 3).

VI. To assess duration of response in patients with liver cancer treated with high-dose conformal EBRT followed by autologous DC vaccine injection by group (Group 1 vs. 2 vs. 3).

VII. To assess overall survival in patients with liver cancer treated with high-dose conformal EBRT followed by autologous DC vaccine injection by group (Group 1 vs. 2 vs. 3).

RADIOLOGIC STUDY OBJECTIVE:

I. To assess the radiologic response over time of primary liver tumors treated with high-dose conformal EBRT followed by autologous DC vaccine injection by group (Group 1 vs. 2 vs. 3).

CORRELATIVE RESEARCH OBJECTIVES:

I. To monitor patients' immune response after vaccine therapy by group (Group 1 vs. 2 vs. 3).

II. To assess the immune response to pneumococcal 13-valent conjugate vaccine (Prevnar) and similar pneumococcal vaccines by group (Group 1 vs. 2 vs. 3).

OUTLINE:

PILOT STUDY (GROUP I) (CLOSED WITH AMENDMENT 3): Patients with unresectable intrahepatic cholangiocarcinoma (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 intratumorally (IT) on day 1 of cycles 2-8 and pneumococcal 13-valent conjugate vaccine intramuscularly (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.

PHASE II STUDY (GROUP II): 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 or other pneumococcal vaccine IM on day 1 of cycles 2-4 only. Patients also receive standard of care atezolizumab intravenously (IV) over 30-60 minutes and bevacizumab IV over 30-90 minutes 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. Additionally, patients undergo an esophagogastroduodenoscopy (EGD) at screening and CT, PET/CT and/or MRI, biopsy and urine and blood sample collection throughout the study.

PHASE II STUDY (GROUP III): Patients with iCCA 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 or other pneumococcal vaccine IM on day 1 of cycles 2-4 only. Patients also receive standard of care atezolizumab IV over 30-60 minutes and tiragolumab IV over 30-60 minutes 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. Additionally, patients undergo CT, PET/CT and/or MRI, biopsy and urine and blood sample collection throughout the study.

After completion of study treatment, patients are followed up at 2 weeks and then every 3 months for 1 year (beginning at week 36 or 12 weeks after last autologous dendritic cell dose whichever is earlier). Patients are then followed every 3 months until disease progression, and then every 6 months until 5 years after registration.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

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

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NON_RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Intervention Type PROCEDURE

Undergo urine and blood sample collection

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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 be accessible using an ultrasound (US)-guided approach for intratumoral DC injection
* No evidence of extrahepatic tumor (excluding tumor thrombus) by computed tomography (CT) or magnetic resonance imaging (MRI) scan

* NOTE: Patients who are not candidates for surgical treatment or for ablation with curative intent are allowed
* Good candidate for standard of care high-dose conformal EBRT in the view of the investigator
* Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0 or 1
* GROUP 2 HCC ONLY: Absolute neutrophil count (ANC) \>= 1000/mm\^3 (obtained =\< 15 days prior to registration)
* GROUP 2 HCC ONLY: Absolute lymphocyte count (ALC) \>= 500/mm\^3 (obtained =\< 15 days prior to registration)
* GROUP 2 HCC ONLY: Absolute monocyte count (AMC) \>= 300/mm\^3 (obtained =\< 15 days prior to registration)
* GROUP 2 HCC ONLY: Platelet count \>= 50,000/mm\^3 (obtained =\< 15 days prior to registration)
* GROUP 2 HCC ONLY: Hemoglobin \>= 9.0 g/dL (obtained =\< 15 days prior to registration)
* GROUP 2 HCC ONLY: Total bilirubin \< 1.5 mg/dL (obtained =\< 15 days prior to registration)
* GROUP 2 HCC ONLY: Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) =\< 5 x upper limit of normal (ULN) (obtained =\< 15 days prior to registration)
* GROUP 2 HCC ONLY: Creatinine =\< 2 mg/dL (obtained =\< 15 days prior to registration)
* GROUP 2 HCC ONLY: Prothrombin time (PT)/international normalized ratio (INR)/activated partial thromboplastin time (aPTT) =\< 1.5 x ULN (obtained =\< 15 days prior to registration)
* GROUP 2 HCC ONLY: Absence of proteinuria at screening as demonstrated by one of the following:

* Urine protein/creatinine (UPC) ratio \< 1.0 at screening OR
* Urine dipstick for proteinuria \< 2+ (patients discovered to have \>= 2+ proteinuria on dipstick urinalysis at baseline should undergo a 24-hour urine collection and must demonstrate =\<1g of protein in 24 hours to be eligible)
* GROUP 3 iCCA ONLY: Absolute neutrophil count (ANC) ≥ 1500/mm\^3 (obtained =\< 15 days prior to registration)
* GROUP 3 iCCA ONLY: Absolute lymphocyte count ≥ 500/mm\^3 (obtained =\< 15 days prior to registration)
* GROUP 3 iCCA ONLY: Absolute monocyte count ≥ 300/mm\^3 (obtained =\< 15 days prior to registration)
* GROUP 3 iCCA ONLY: Platelet count ≥ 100,000/mm\^3 (obtained =\< 15 days prior to registration)
* GROUP 3 iCCA ONLY: Hemoglobin ≥ 9.0 g/dL (obtained =\< 15 days prior to registration)
* GROUP 3 iCCA ONLY: Total bilirubin \< 1.5 x ULN (obtained =\< 15 days prior to registration)
* GROUP 3 iCCA ONLY: Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) and alkaline phosphatase (ALP) ≤ 2.5 x ULN (obtained =\< 15 days prior to registration)
* GROUP 3 iCCA ONLY: Creatinine ≤ 2 mg/dL (obtained =\< 15 days prior to registration)
* GROUP 3 iCCA ONLY: Serum albumin ≥ 25 g/L (2.5 g/dL) (obtained =\< 15 days prior to registration)
* GROUP 3 iCCA ONLY: PT/INR/aPTT ≤ 1.5 x ULN (obtained =\< 15 days prior to registration)

* NOTE: If patient is receiving therapeutic anticoagulation, patient must be on a stable anticoagulant regimen
* GROUP 3 iCCA ONLY: Calcium ≤ 12 mg/dl or corrected serum calcium ≤ ULN (obtained =\< 15 days prior to registration)
* Negative pregnancy test done =\< 8 days prior to registration, for persons of childbearing potential only
* GROUP 3 ONLY: Negative hepatitis B surface antigen (HBsAg) test at screening
* GROUP 3 ONLY: Negative hepatitis C virus antibody (HCV Ab) test at screening, or positive HCV antibody test followed by a negative HCV ribonucleic acid (RNA) test at screening. (NOTE: HCV RNA test will be performed only for patients who have a positive HCV antibody test.)
* Ability to provide written consent
* Willingness to return to enrolling institution for follow-up (during the active monitoring phase of the study)
* Willingness to provide blood and tissue samples for correlative research purposes

Exclusion Criteria

* 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:

* Ongoing or active infection requiring systemic treatment or that could impact patient safety
* Severe infection ≤ 4 weeks prior to registration, including, but not limited to, hospitalization for complications of infection, bacteremia, or severe pneumonia
* Significant cardiovascular disease (New York Heart Association \[NYHA\] class II), symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia
* Or, psychiatric illness/social situations (e.g., substance abuse) that would limit compliance with study requirements
* Receiving any other investigational agent that would be considered a treatment for the primary neoplasm
* Other active malignancy =\< 1 year prior to registration that is considered by the investigator to interfere with the current treatment or measurement of outcomes
* Major surgery =\< 4 weeks prior to enrollment (other than diagnostic surgery or surgical spacer placement in preparation for radiation treatment), or anticipation of need for a major surgical procedure during the study
* History of hypersensitivity or anaphylactoid reactions to pneumococcal vaccine or any component of the formulation, including diphtheria toxoid
* Active or history of autoimmune disease or immune deficiency, including but not limited to,myasthenia gravis, myositis, autoimmune hepatitis, Crohn's disease, inflammatory bowel disease, antiphospholipid antibody syndrome, rheumatoid arthritis, Sjogren syndrome, systemic lupus erythematosus, Guillain-Barre syndrome, multiple sclerosis, Wegener granulomatosis, or similar conditions

* NOTE: Exceptions are allowed for:

* Patients with hypothyroidism on thyroid replacement therapy
* Patients with type 1 diabetes mellitus on insulin regimen
* Patients with eczema, psoriasis lichen simplex chronicus, or vitiligo with dermatologic manifestations only (e.g., patients with psoriatic arthritis are excluded) are eligible for the study provided all of the following conditions are met:

* Rash must cover \< 10% of body surface area
* Disease is well controlled at baseline and requires only low-potency topical corticosteroids
* There has been no occurrence of acute exacerbations of the underlying condition requiring psoralen plus ultraviolet A radiation, methotrexate, retinoids, biologic agents, oral calcineurin inhibitors, or high potency or oral corticosteroids ≤ 12 months prior to registration
* Requires anticoagulant treatment (INR \> 1.5 x ULN) or use of anti-platelet agents that cannot be discontinued for the intratumoral injection procedure

* NOTE: Heparin for line patency without detectable lab abnormalities in coagulation will be allowed
* Corticosteroids =\< 2 weeks prior to registration, including oral, intravenous (IV), subcutaneous, or inhaled routes of administration

* NOTE: Patients on chronic corticosteroids for adrenal insufficiency or other reasons may enroll if they receive less than 10 mg/day of prednisone (or equivalent)
* NOTE: Exception allowed for patients who need prophylactic steroids prior to imaging for contrast allergies

* Exception: Patients who received acute, low-dose systemic immunosuppressant medication or a one-time pulse dose of systemic immunosuppressant medication (e.g., 48 hours of corticosteroids for a contrast allergy) are eligible for the study
* Exception: Patients who received mineralocorticoids (e.g., fludrocortisone), corticosteroids for chronic obstructive pulmonary disease (COPD) or asthma, or low-dose corticosteroids for orthostatic hypotension or adrenal insufficiency are eligible for the study
* History of myocardial infarction =\< 6 months, or congestive heart failure requiring use of ongoing maintenance therapy for life-threatening ventricular arrhythmias
* Child Pugh class B or C cirrhosis of the liver
* Previously received immune modulating therapies including but not limited to immune checkpoint inhibitors targeting PD-1 PDL-1 CTLA4, etc.; or prior dendritic cell therapy
* Prior liver radiation, including radioembolization
* GROUP 2 ONLY: Barcelona Clinic Liver Cancer (BCLC) stage D disease
* GROUP 2 ONLY: History of untreated high-risk gastroesophageal varices
* GROUP 3 ONLY: History of idiopathic pulmonary fibrosis, organizing pneumonia (e.g., bronchiolitis obliterans), drug-induced pneumonitis, or idiopathic pneumonitis, or evidence of active pneumonitis
* Active tuberculosis
* Treatment with therapeutic oral or IV antibiotics ≤ 2 weeks prior to registration

* NOTE: Exception for patients receiving prophylactic antibiotics (e.g., to prevent a urinary tract infection or chronic obstructive pulmonary disease exacerbation) are eligible for the study
* Prior allogeneic stem cell or solid organ transplantation
* Treatment with a live, attenuated vaccine ≤ 4 weeks prior to registration, or anticipation of need for such a vaccine during study treatment, within 90 days after the final dose of tiragolumab, or within 5 months after the final dose of atezolizumab

* NOTE: Patients being treated with chemotherapy (e.g., carboplatin, cisplatin, pemetrexed, paclitaxel, or gemcitabine) should not receive live vaccines
* GROUP 3 ONLY: Acute Epstein-Barr virus (EBV) infection or known or suspected chronic active EBV at screening

* NOTE: Patients with symptoms such as splenomegaly, fever, sore throat, non-malignant cervical lymphadenopathy, and/or tonsillar exudate, should undergo an EBV polymerase chain reaction (PCR) test to screen for acute infection or suspected chronic active infection. Patients with a positive EBV PCR test are excluded. Patients with positive Epstein-Barr virus (EBV) viral capsid antigen immunoglobulin M (IgM) test at screening are excluded
* GROUP 3 ONLY: History of severe allergic anaphylactic reactions to chimeric or humanized antibodies or fusion proteins
* GROUP 3 ONLY: Known hypersensitivity to Chinese hamster ovary cell products or to any component of the atezolizumab or tiragolumab formulation
* GROUP 3 ONLY: Known allergy or hypersensitivity to any component of the chemotherapy regimen the patient may receive during the study

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Lewis R. Roberts, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Mayo Clinic in Rochester

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Mayo Clinic in Rochester

Rochester, Minnesota, United States

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

United States

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Clinical Trials Referral Office

Role: CONTACT

[email protected]

855-776-0015

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Clinical Trials Referral Office

Role: primary

[email protected]

855-776-0015

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

R01CA274985

Identifier Type: NIH

Identifier Source: secondary_id

View Link

R01CA294704

Identifier Type: NIH

Identifier Source: secondary_id

View Link

NCI-2019-02452

Identifier Type: REGISTRY

Identifier Source: secondary_id

16-009335

Identifier Type: OTHER

Identifier Source: secondary_id

MC1641

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Atezolizumab and Bevacizumab With Combined Radiotherapy for Advanced Hepatocellular Carcinoma

NCT05908916 NOT_YET_RECRUITING PHASE2

A Study Evaluating Atezolizumab, With or Without Bevacizumab, in Participants With Unresectable Hepatocellular Carcinoma and Child-Pugh B7 and B8 Cirrhosis

NCT06096779 RECRUITING PHASE2

A Study to Evaluate of PM8002 Combined With PM1009 in Patients With First-line HCC

NCT06584071 NOT_YET_RECRUITING PHASE1/PHASE2

Atezolizumab and Bevacizumab Before Surgery for the Treatment of Resectable Liver Cancer

NCT04721132 ACTIVE_NOT_RECRUITING PHASE2

A Study of Atezolizumab and Bevacizumab in Hepatocellular Carcinoma

NCT04829383 ACTIVE_NOT_RECRUITING PHASE2

Atezolizumab and Bevacizumab with Proton Radiotherapy for Unresectable Hepatocellular Carcinoma

NCT06133062 RECRUITING PHASE2

Atezolizumab+Bevacizumab+SBRT in Unresectable HCC

NCT05096715 RECRUITING PHASE1

A Study to Assess PV-10 Chemoablation of Cancer of the Liver

NCT00986661 UNKNOWN PHASE1

A Phase II Study of Nivolumab + Ipilimumab in Advanced HCC Patients Who Have Progressed on First Line Atezolizumab + Bevacizumab

NCT05199285 TERMINATED PHASE2

Infusion of PD1/PDL1/CTLA4 Inhibitors Via Hepatic Arterial for Immunotherapy of Hepatocellular Carcinoma

NCT03949231 RECRUITING PHASE3

Immunotherapy Using Precision T Cells Specific to Multiple Common Tumor-Associated Antigen Combined With Transcatheter Arterial Chemoembolization for the Treatment of Advanced Hepatocellular Carcinoma

NCT02638857 UNKNOWN PHASE1/PHASE2

PD-L1 Antibody + Bevacizumab With Hepatic Arterial Infusion Chemotherapy for Advanced HCC

NCT06742424 RECRUITING PHASE2

Curative Therapy After Atezolizumab and Bevacizumab Treatment for Unresectable Hepatocellular Carcinoma

NCT07091942 RECRUITING

A Study of Atezolizumab Plus Bevacizumab Versus Active Surveillance as Adjuvant Therapy in Patients With Hepatocellular Carcinoma at High Risk of Recurrence After Surgical Resection or Ablation

NCT04102098 ACTIVE_NOT_RECRUITING PHASE3

Proton Therapy and Bevacizumab for Primary Liver Tumors

NCT00426829 TERMINATED PHASE1

Durvalumab With/Without Tremelimumab After Palliative Hypofractionated Radiotherapy for Hepatocellular Carcinoma

NCT04430452 RECRUITING PHASE2

Phase I Intratumoral Dendritic Cell Immunotherapy in Thermally Ablated Liver Metastases

NCT00185874 TERMINATED PHASE1

DYNAmic Immune Microenvironment of HCC Treated With atezolIzumab Plus bevaCizumab

NCT04954339 ACTIVE_NOT_RECRUITING PHASE2

An Observational Study to Learn More About How Well a Treatment Works When Given After Treatment With Atezolizumab and Bevacizumab or Another Similar Combination of Drugs in Adults With Liver Cancer That Cannot be Treated With Surgery

NCT06117891 RECRUITING

Locoregional Therapy Combined With Bevacizumab and PD1/L1 Inhibitor in Advanced Hepatocellular Carcinoma

NCT06323382 RECRUITING

Study to Evaluate the Efficacy and Safety of Atezolizumab and Bevacizumab as Neoadjuvant Plus Adjuvant Treatment in HCC

NCT07018947 NOT_YET_RECRUITING PHASE2

A Study of Atezolizumab (Tecentriq) in Combination With Bevacizumab to Investigate Safety and Efficacy in Patients With Unresectable Hepatocellular Carcinoma Not Previously Treated With Systemic Therapy-Amethista

NCT04487067 COMPLETED PHASE3

Predictive Biomarkers in Patients With Advanced Hepatocellular Carcinoma Treated With Atezolizumab Plus Bevacizumab

NCT05173298 RECRUITING

Pressure Enabled Delivery of SD-101 With Checkpoint Blockade for Primary Liver Tumors

NCT05220722 TERMINATED PHASE1/PHASE2

An Exploratory Study of Atezolizumab and Bevacizumab in Hepatocellular Carcinoma and Non-Small Cell Lung Cancer With Liver Metastases (INTEGRATE)

NCT04563338 RECRUITING PHASE2

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

Study Results

Basic Information

Brief Summary

Related Clinical Trials

Atezolizumab and Bevacizumab With Photon Radiotherapy for Unresectable Hepatocellular Carcinoma

Trial of Atezolizumab and Bevacizumab With SRF388 or Placebo in Patients With Hepatocellular Carcinoma

Atezolizumab in Combination With a Multi-Kinase Inhibitor for the Treatment of Unresectable, Locally Advanced, or Metastatic Liver Cancer

A Study to Determine Whether Chemotherapy and Atezolizumab is Better Than Chemotherapy, Bevacizumab and Atezolizumab in Patients With Advanced Liver Cancer

A Study Combining Personalized Neoantigen-based Dendritic Cell Vaccine With Microwave Ablation for the Treatment of Hepatocellular Carcinoma

Detailed Description

Conditions

Study Design

Study Groups

Phase II Group 2 (EBRT, dendritic cells, Prevnar, atezo, bev)

Atezolizumab

Bevacizumab

External Beam Radiation Therapy

Pheresis

Pneumococcal 13-valent Conjugate Vaccine

Therapeutic Autologous Dendritic Cells

Esophagogastroduodenoscopy

Computed Tomography

Positron Emission Tomography

Magnetic Resonance Imaging

Biopsy Procedure

Biospecimen Collection

Pilot study (pheresis, EBRT, dendritic cells, Prevnar)

External Beam Radiation Therapy

Pheresis

Pneumococcal 13-valent Conjugate Vaccine

Therapeutic Autologous Dendritic Cells

Phase II Group 3 (EBRT, dendritic cells, Prevnar, atezo, tir)

Atezolizumab

External Beam Radiation Therapy

Pheresis

Pneumococcal 13-valent Conjugate Vaccine

Therapeutic Autologous Dendritic Cells

Tiragolumab

Computed Tomography

Positron Emission Tomography

Magnetic Resonance Imaging

Biopsy Procedure

Biospecimen Collection

Interventions

Atezolizumab

Bevacizumab

External Beam Radiation Therapy

Pheresis

Pneumococcal 13-valent Conjugate Vaccine

Therapeutic Autologous Dendritic Cells

Tiragolumab

Esophagogastroduodenoscopy

Computed Tomography

Positron Emission Tomography

Magnetic Resonance Imaging

Biopsy Procedure

Biospecimen Collection

Other Intervention Names

Eligibility Criteria

Inclusion Criteria

Exclusion Criteria

Sponsors

National Cancer Institute (NCI)

Mayo Clinic

Responsible Party

Principal Investigators

Lewis R. Roberts, MD, PhD

Locations

Mayo Clinic in Rochester

Countries

Central Contacts

Clinical Trials Referral Office

Facility Contacts

Clinical Trials Referral Office

Related Links

Other Identifiers

R01CA274985

R01CA294704

NCI-2019-02452