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Stage III Hepatocellular Carcinoma AJCC v8Phase 1/2NCT03942328

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

A Phase 1/2 study testing Atezolizumab, Bevacizumab and External Beam Radiation Therapy in people with Stage III Hepatocellular Carcinoma AJCC v8 and Stage III Intrahepatic Cholangiocarcinoma AJCC v8, run by Mayo Clinic at 1 site in United States.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial 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… Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Atezolizumab, Bevacizumab and External Beam Radiation Therapy
Could I receive a placebo?
No, everyone receives an active treatment
How many people
85 participants
Where
1 siteUnited States
Study dates
19 Sep 2019to 31 Aug 2030
Phase
Phase 1/2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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)
Show all 38Show fewer
  • 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) ≥ 1000/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 ≥ 50,000/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: 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
  • 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

Who cannot join

  • 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.
Show all 42Show fewer
  • 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
  • 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

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Clinical Trials Referral Office contact

855-776-0015

mayocliniccancerstudies@mayo.edu

United States1 site, 1 recruiting

  • Mayo Clinic in Rochester

    Rochester, Minnesota, 55905

    Clinical Trials Referral Office, 855-776-0015, mayocliniccancerstudies@mayo.edu

    Lewis R. Roberts, MD, PhD

    Recruiting

Other trials in United States

About this study

Official title: 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

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.

Read the detailed description

PRIMARY OBJECTIVE:

  1. 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:

  1. 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).

  1. 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:

  1. 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:

  1. 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 durvalumab 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. 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.

Being tested
Atezolizumab, Bevacizumab, External Beam Radiation Therapy, Pheresis, Pneumococcal 13-valent Conjugate Vaccine
Medical subject headings
Carcinoma, Hepatocellular, Cholangiocarcinoma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • AtezolizumabBiological

    Also called MPDL 3280A, MPDL 328OA, MPDL-3280A, MPDL3280A

    Given IV

  • BevacizumabBiological

    Also called ABP 215, Anti-VEGF, Anti-VEGF Humanized Monoclonal Antibody, Anti-VEGF Monoclonal Antibody SIBP04

    Given IV

  • External Beam Radiation TherapyRadiation

    Also called Definitive Radiation Therapy, EBRT, External Beam Radiation, External Beam Radiotherapy

    Undergo high-dose EBRT

  • PheresisProcedure or surgery

    Also called Apheresed, Apheresis, Blood Component Removal, Collection, Apheresis/Leukapheresis

    Undergo apheresis

  • Pneumococcal 13-valent Conjugate VaccineBiological

    Also called PCV 13, PCV13 Vaccine, Prevnar 13

    Given IM

  • Therapeutic Autologous Dendritic CellsBiological

    Given IT

  • DurvalumabBiological

    Also called Imfinzi, MEDI 4736, MEDI-4736, MEDI4736

    Given IV

  • EsophagogastroduodenoscopyProcedure or surgery

    Also called EGD, Upper Endoscopy

    Undergo EGD

  • Computed TomographyProcedure or surgery

    Also called CAT, CAT Scan, Computed Axial Tomography, computerized axial tomography

    Undergo CT or PET/CT

  • Positron Emission TomographyProcedure or surgery

    Also called Medical Imaging, Positron Emission Tomography, PET, PET Scan, positron emission tomography scan

    Undergo PET/CT

  • Magnetic Resonance ImagingProcedure or surgery

    Also called MRI, Magnetic Resonance Imaging (MRI), Medical Imaging, Magnetic Resonance / Nuclear Magnetic Resonance, MR

    Undergo MRI

  • Biopsy ProcedureProcedure or surgery

    Also called BIOPSY, Bx

    Undergo biopsy

  • Biospecimen CollectionProcedure or surgery

    Also called Biological Sample Collection, Biospecimen Collected, Specimen Collection

    Undergo urine and blood sample collection

Study groups in NCT03942328
Study groupRoleWhat they receive
Phase II Group 2 (EBRT, dendritic cells, Prevnar, atezo, bev)ExperimentalPatients 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 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 EGD at screening and CT, PET/CT and/or MRI, biopsy and urine and blood sample collection throughout the study.
Receives: Biological: Atezolizumab; Biological: Bevacizumab; Radiation: External Beam Radiation Therapy; Procedure: Pheresis; Biological: Pneumococcal 13-valent Conjugate Vaccine; Biological: Therapeutic Autologous Dendritic Cells; Procedure: Esophagogastroduodenoscopy; Procedure: Computed Tomography; Procedure: Positron Emission Tomography; Procedure: Magnetic Resonance Imaging; Procedure: Biopsy Procedure; Procedure: Biospecimen Collection
Pilot study (pheresis, EBRT, dendritic cells, Prevnar)ExperimentalPatients 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. (CLOSED WITH AMENDMENT 3)
Receives: Radiation: External Beam Radiation Therapy; Procedure: Pheresis; Biological: Pneumococcal 13-valent Conjugate Vaccine; Biological: Therapeutic Autologous Dendritic Cells
Phase II Group 3 (EBRT, dendritic cells, Prevnar, atezo, tir)ExperimentalPatients 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 durvalumab 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. Additionally, patients undergo CT, PET/CT and/or MRI, biopsy and urine and blood sample collection throughout the study.
Receives: Biological: Atezolizumab; Radiation: External Beam Radiation Therapy; Procedure: Pheresis; Biological: Pneumococcal 13-valent Conjugate Vaccine; Biological: Therapeutic Autologous Dendritic Cells; Biological: Durvalumab; Procedure: Computed Tomography; Procedure: Positron Emission Tomography; Procedure: Magnetic Resonance Imaging; Procedure: Biopsy Procedure; Procedure: Biospecimen Collection

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Incidence of significant toxicity (Pilot study)

    A significant toxicity is defined as a dose limiting toxicity that is possibly, probably, or definitely related to dendritic cell (DC) treatment. Toxicities will be assessed using the Cancer Therapy Evaluation Program active version of the Common Terminology Criteria for Adverse Events.

    Measured: Up to completion of cycle 2 (each cycle is 28 days)

  2. Progression-free survival rate at 2 years (Phase II)

    Defined as the time from registration to disease progression or death due to all causes.

    Measured: At 2 years

  3. PFS (Phase II Group 3)

    Defined as the time from registration to disease progression or death due to all causes.

    Measured: Up to 5 years

Secondary outcomes (7)

  1. Overall response rate

    The overall response rate will be estimated by the number of patients with an objective status of complete response (CR) or partial response (PR) divided by the total number of evaluable patients. Exact binomial 95% confidence intervals for the true overall response rate will be calculated.

    Measured: Up to 1 year post treatment

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

    The feasibility of the regimen will be estimated by the number of patients who received at least one dose of intratumoral DC injection divided by the total number of patients who received apheresis.

    Measured: Up to 1 year post treatment

  3. Clinical benefit rate

    The clinical benefit rate will be estimated by the number of patients with an objective status of stable disease or CR or PR at any time divided by the total number of evaluable patients. Exact binomial 95% confidence intervals for the true clinical benefit rate will be calculate

    Measured: Up to 1 year post treatment

  4. Time to response

    Time to response is defined for all evaluable patients who have achieved an objective response as the date of initiation of vaccination treatment to the date at which the patient's objective status is first noted to be either a CR or PR. Time to response will be summarized descriptively using Kaplan-Meier methodology.

    Measured: Up to 1 year post treatment

  5. Duration of response

    Duration of response is defined for all evaluable patients who have achieved an objective response as the date at which the patient's objective status is first noted to be either a CR or PR to the earliest date progression is documented. Duration of response will be summarized descriptively using Kaplan-Meier methodology.

    Measured: Up to 1 year post treatment

  6. Overall survival

    Defined as the time from registration to death from any cause.

    Measured: Up to 5 years

  7. Progression-free survival

    Defined as the time from registration to disease progression or death due to all causes.

    Measured: Up to 5 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted8 May 2019
  2. Study start19 Sep 2019
  3. Primary completion31 Aug 2030 (estimated)
  4. Study completion31 Aug 2030 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1/2
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Crossover
Masking
None (open label)
Enrolment
85 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03942328
Sponsor's protocol ID
MC1641
Other IDs
R01CA274985, R01CA294704, 16-009335
Status last verified
Sep 2026
First submitted
6 May 2019
Last updated
5 Oct 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing Atezolizumab, Bevacizumab and External Beam Radiation Therapy in people with Stage III Hepatocellular Carcinoma AJCC v8 and Stage III Intrahepatic Cholangiocarcinoma AJCC v8, run by Mayo Clinic at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 38 inclusion and 42 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 5 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Clinical Trials Referral Office (855-776-0015, mayocliniccancerstudies@mayo.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Incidence of significant toxicity (Pilot study) (time frame: Up to completion of cycle 2 (each cycle is 28 days)). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03942328.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Oct 2026.

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