Nivolumab and Yttrium Y 90 Glass Microspheres in Treating Patients With Advanced Liver Cancer

Conditions

• Stage IIIA Hepatocellular Carcinoma
• Stage IIIB Hepatocellular Carcinoma
• Stage IIIC Hepatocellular Carcinoma
• Stage IVA Hepatocellular Carcinoma
• Stage IVB Hepatocellular Carcinoma

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Laboratory Biomarker Analysis — OTHER
  Correlative studies
• Nivolumab — BIOLOGICAL
  Given IV
• Yttrium Y 90 Glass Microspheres — RADIATION
  Given IA

Study Details

The purpose of this study is to identify maximum tolerated dose (MTD), that is, the highest dose of the study drug nivolumab that does not cause unacceptable side effects, for combination treatment of nivolumab and yttrium Y 90 glass microspheres (Y-90). Also, to evaluate the efficacy (the effect of drug on your tumor) and the tolerability (the effect of the drug on your body) of nivolumab, when given with standard of care Y-90 (Therasphere). Nivolumab is currently Food and Drug Administration (FDA) approved for other cancers, but has not yet been investigated in advanced or refractory hepatocellular carcinoma. Nivolumab is an antibody (a human protein that sticks to a part of the tumor and/or immune cells) designed to allow the body's immune system to work against tumor cells. Y-90 is currently FDA approved for the treatment of hepatocellular carcinomas, but has not yet been investigated in combination with nivolumab for this disease.

Key Dates

Start date

Jul 31, 2016

Status verified

Jan 2022

Primary completion

Jul 17, 2019

Completion

Nov 1, 2020

Study Design

Enrollment

27 participants (actual)

Allocation

NA

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Arms

• Experimental: Treatment (yttrium Y 90 glass microspheres, nivolumab)
  Patients receive yttrium Y 90 glass microspheres IA. Approximately 4 weeks after yttrium Y 90 glass microspheres treatment, patients receive nivolumab IV over 30-60 minutes on days 1 and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.

Primary Outcome Measure

Maximum Tolerated Dose (MTD) [ Time Frame: The first cycle of treatment with nivolumab (28 days) ]

Locations (1)

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