At a glance
ClinicalIndex Comparison Record- ✓AASLD-confirmed hepatocellular carcinoma with Child-Pugh score A or B (≤B8)
- ✓At least 1 measurable lesion per RECIST; previously irradiated lesion eligible if progressed
- ✓Advanced disease not amenable to transplant or resection
- ✓ECOG performance status 0, 1, or 2
- ✕Prior nivolumab or any PD-1/PD-L1 antagonist
- ✕History of severe allergic reactions (grade 4 allergy, anaphylactic reaction) to nivolumab components
- ✕Active autoimmune disease or history that might recur affecting vital organs or requiring chronic systemic corticosteroids (≥1 month duration)
- ✕Untreated CNS metastases; treated stable metastases off corticosteroids for ≥6 weeks permitted
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Phase I/Ib Study of Nivolumab in Combination With Therasphere (Yttrium-90) in Patients With Advanced Hepatocellular Carcinoma
In Brief
A Phase 1 clinical trial evaluating Laboratory Biomarker Analysis, Nivolumab, and 1 other intervention for Stage IIIA Hepatocellular Carcinoma and 4 related conditions. Completed, enrolled 27 participants across 1 site.
Detailed Summary
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.
Study Details
Timeline
Interventions
Correlative studies
Given IV
Given IA