Pembrolizumab Plus Y90 Radioembolization in HCC Subjects

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Disease Information

Descriptive Information
Brief Title † Pembrolizumab Plus Y90 Radioembolization in HCC Subjects
Official Title † A Pilot Study of Pembrolizumab in Combination With Y90 Radioembolization in Subjects With Poor Prognosis Hepatocellular Carcinoma With Preserved Liver Function. HCRN: GI15-225
Brief Summary This is an open-label multi-center trial designed to evaluate the efficacy as well as the safety of combining pembrolizumab with Yttrium-90 (Y90) radioembolization in subjects with poor prognosis (high risk) HCC not eligible for liver transplant or surgical resection with well compensated liver function. Treatment will consist of pembrolizumab 200mg IV every 3 weeks in conjunction with Y90 radioembolization performed one week after the first dose of pembrolizumab. If bilobar disease is present, a second Y90 radioembolization will be performed no later than 4 weeks after the first procedure to the contralateral hepatic lobe.
Detailed Description If a second Y90 radioembolization treatment is required for bilobar disease, this should occur within 4 weeks of the initial procedure (between Cycles 2 and 3 of pembrolizumab). The next dose of pembrolizumab should be separated from the Y90 radioembolization by at least one week. Imaging will be obtained every 9 weeks (after every 3 pembrolizumab treatment) to assess for tumor response and to evaluate for progression. Subjects will remain on treatment until documented tumor progression, unacceptable toxicity, study withdrawal or death. Screening Angiography (shunt study): During screening, subjects will undergo angiography using technetium-99-labeled macroaggregated albumin to detect any uptake outside the liver via measurement of hepatopulmonary shunting. Prior to the angiography, a local anesthetic (to numb the area prior to catheter insertion) and sedation will be administered to the subject, as per institutional standards. This procedure is standard of care for subjects prior to Y90 radioembolization, and will be performed per institutional site standards. Hepatopulmonary shunting must be
Study Phase Early Phase 1
Study Type † Interventional
Study Design †
Primary Outcome Measure † Progression free survival (PFS)
Secondary Outcome Measure † Assess Safety - toxicities as defined by the NCI CTCAE v4
Condition † Hepatocellular Carcinoma
Intervention † DrugPembrolizumab
Study Arms / Comparison Groups pembrolizumab + Y90 radioembolization Pembrolizumab 200mg IV every 3 weeks in conjunction with Y90 radioembolization (performed one week after the first dose of pembrolizumab)
Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information
Recruitment Status † Drug
Estimated Enrollment † 30
Start Date † March 28, 2017
Completion Date January 2020
Primary Completion Date January 2018
Eligibility Criteria † Inclusion Criteria: Subject must meet all of the following applicable inclusion criteria to participate in this study: - Written informed consent and HIPAA authorization for release of personal health information prior to registration. NOTE: HIPAA authorization may be included in the informed consent or obtained separately - ECOG Performance Status of 0-1 - Locally advanced HCC as defined by: 1) tissue diagnosis OR 2) alpha-fetoprotein (AFP) > 400 ng/mL with compatible mass on contrast-enhanced imaging OR 3) compatible mass on dual phase CT or dynamic contrast enhanced MRI demonstrating both arterial hypervascularity and delayed washout - Hepatopulmonary shunting 4 weeks prior - Has had prior chemotherapy, targeted small molecule therapy or radiation therapy within 2 weeks prior to registration, or who has not recovered (i.e., (i.e., ≤ Grade 1 or baseline)) from AEs due to previously administered agents - If had major surgery, subject must have recovered adequately from the toxicity and/or complications from the intervention prior to study registration - Complete portal vein occlusion - Vascular abnormalities or bleeding diathesis that indicates hepatic artery catheterization is contraindicated - Received prior therapy with an anti-PD-1, anti-PD-L1, or anti-CTLA-4 antibody - Known history of HIV - Untreated active HBV - Dual infection with HBV/HCV or other hepatitis combinations at study entry - Known history of, or any evidence of active, non-infectious pneumonitis - History of organ transplantation including previous history of liver transplantation - Active infection requiring systemic therapy - Pregnant or breastfeeding (NOTE: breast milk cannot be stored for future use while the mother is being treated on study). - Has history or current evidence of any condition, therapy or laboratory abnormality that may confound results or interfere with subject's participation in the trial. - Known additional malignancy that is active and/or progressive requiring treatment; exceptions include basal cell or squamous cell skin cancer, in situ cervical or bladder cancer, or other cancer for which the subject has been disease-free for at least three years. - Has received a live vaccine within 30 days of planned start of study therapy.
Gender All
Ages 18 Years - N/A
Accepts Healthy Volunteers No
Contacts †† Ahran Lee, 317.634.5842,
Location Countries † United States
Administrative Information
NCT ID † NCT03099564
Organization ID HCRN GI15-225
Secondary IDs ††
Responsible Party Sponsor-Investigator
Study Sponsor † Autumn McRee, MD
Collaborators †† Merck Sharp & Dohme Corp.
Investigators † Study Chair: Autumn McRee, MD, Hoosier Cancer Research Network
Information Provided By
Verification Date June 2017
First Received Date † March 28, 2017
Last Updated Date June 8, 2017
† Required WHO trial registration data element.
†† WHO trial registration data element that is required only if it exists.
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