A Study to Test the Safety and Feasibility of Nivolumab With Drug Eluting Bead Transarterial Chemoembolization in Patients With Liver Cancer

Conditions:Liver Cancer, Cancer, Cancer
Therapuetic Areas:Oncology
Age Range:18 - Any
Start Date:April 28, 2017
End Date:April 2019
Contact:James Harding, MD

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A Multicenter Pilot Study of Nivolumab With Drug Eluting Bead Transarterial Chemoembolization in Patients With Advanced Hepatocellular Carcinoma

The purpose of the study is to find out the effects of using nivolumab with Drug Eluting Bead
Transarterial Chemoembolization (deb-TACE) in the treatment of liver cancer.

Inclusion Criteria:

- Age 18 and over at the time of consent

- Histology and/or cytology confirmed HCC per the enrolling institution

- Measurable disease per RECIST v1.1

- Disease not amenable to curative or transplant surgery (BCLC Stage B); disease must be
reviewed by members of disease management team at the local enrolling institution and
be amenable to deb-TACE to treat all sites of disease in one session

- ECOG Performance status 0 or 1

- Child-Pugh Class A

- Adequate bone marrow, hepatic, and renal function defined as:

- Platelet count ≥ 75,000/mm3

- Absolute neutrophil count ≥ 1,000/mm3

- Hemoglobin ≥ 9 g/dL

- Total bilirubin < 3.0 × ULN (upper limit of normal)

- Aspartate transaminase (AST) and alanine transaminase (ALT) ≤ 5 × ULN

- Albumin ≥ 2.8 g/dL

- Serum creatinine ≤ 1.5 mg/dL or calculated creatinine clearance ≥ 40 mL/min as
determined by the Cockcroft-Gault equation

- Suppression of HBV (≤ 100 IU/mL by HBV PCR) with antivirals per the local standard of
care if prior or current HBV exposure or infection.

- Active HCV infection without treatment is permitted. Concomitant treatment of HCV is
not permitted on this study.

Exclusion Criteria:

- Vascular invasion or extrahepatic spread

- History of liver allograft; prior hepatic resection is allowed.

- Prior embolization and/or ablation

- Contraindication to angiography/embolization procedure based on judgment of the
treating investigator.

- Prior treatment with an anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CTLA-4 antibody, or
any other antibody or drug specifically targeting T-cell costimulation or immune
checkpoint pathways

- Known history of testing positive for human immunodeficiency virus (HIV) or known
acquired immunodeficiency syndrome (AIDS)

- A history of a severe contrast allergy (.i.e. anaphylaxis) not controlled with

- Patients should be excluded if they have a condition requiring chronic systemic
treatment with either corticosteroids (> 10 mg daily prednisone equivalents) or other
immunosuppressive medications within 14 days of study drug administration. Inhaled or
topical steroids and adrenal replacement doses > 10 mg daily prednisone equivalents
are permitted in the absence of active autoimmune disease. Patients with contrast
allergies who can tolerate contrast with corticosteroid premedication are not

- An active, known or suspected autoimmune disease. Subjects are permitted to enroll if
they have vitiligo, type I diabetes mellitus, residual hypothyroidism due to
autoimmune condition only requiring hormone replacement, psoriasis not requiring
systemic treatment, or conditions not expected to recur in the absence of an external

- Subjects with history of another primary cancer, with the exception of: a) curatively
resected non-melanoma skin cancer; b) curatively treated cervical carcinoma in situ;
or c) other primary solid tumor with no known active disease present that in the
opinion of the investigator will not affect patient outcome in the setting of current
HCC diagnosis.

- Any condition that, in the opinion of the investigator, would interfere with
evaluation of the investigational product or interpretation of subject safety or study

- Women of childbearing potential (WOCBP) or sexually active men must use appropriate
method(s) of contraception.

- Women of childbearing potential (WOCBP) must use appropriate method(s) of
contraception while on study treatment. WOCBP should use an adequate method to
avoid pregnancy during study treatment and for 5 months (30 days plus the time
required for nivolumab to undergo five half-lives) after the last dose of
investigational drug

- Men who are sexually active with WOCBP must use any contraceptive method with a
failure rate of less than 1% per year Men receiving nivolumab and who are
sexually active with WOCBP will be instructed to adhere to contraception during
study treatment and for a period of 7 months after the last dose of
investigational product

- Women who are not of childbearing potential (ie, who are postmenopausal or
surgically sterile, as well as azoospermic men do not require contraception

- Women of childbearing potential must have a negative serum or urine pregnancy test
(minimum sensitivity 25 IU/L or equivalent units of HCG) within 24 hours prior to the
start of nivolumab. Elevated HCG for other explained and documented reasons is

- Lactating woman
We found this trial at
200 First Street SW
Rochester, Minnesota 55905
Phone: 904-953-2000
Mayo Clinic Cancer Center The Mayo Clinic Cancer Center is a National Cancer Institute-designated comprehensive...
Rochester, MN
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1275 York Ave
New York, New York 10021
(212) 639-2000
Phone: 646-888-4314
Memorial Sloan Kettering Cancer Center Memorial Sloan Kettering Cancer Center — the world's oldest and...
New York, NY
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Philadelphia, Pennsylvania 19104
Phone: 800-789-7366
Philadelphia, PA
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660 S Euclid Ave
Saint Louis, Missouri 63110
(314) 362-5000
Principal Investigator: Benjamin Tan, MD
Phone: 314-747-7222
Washington University School of Medicine Washington University Physicians is the clinical practice of the School...
Saint Louis, MO
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