NCT03812562

Nivolumab and Yttrium-90 in Treating Patients With Liver Cancer Undergoing Surgical Resection

Pilot Study of Nivolumab in Combination With Therasphere (Yttrium-90) for Treatment of Hepatocellular Carcinoma (HCC) With Intent for Resection

• Status: Terminated
• Phase: EARLY_Phase 1
• Study type: Interventional
• Enrollment: 2 (actual)
• Sponsor: Northwestern University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This early phase I trial studies how well nivolumab and yttrium-90 work in treating patients with liver cancer who are undergoing surgical resection. Immunotherapy with monoclonal antibodies, such as nivolumab, may help the body?s immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Radioactive drugs, such as yttrium-90, may carry radiation directly to tumor cells and not harm normal cells. Giving nivolumab and yttrium-90 may work better in treating patients with liver cancer.

Detailed description

PRIMARY OBJECTIVES: I. To assess the hepatocellular carcinoma (HCC) recurrence rate post-resection in patients intended to undergo resection post yttrium Y 90 glass microspheres (yttrium-90 \[Y-90\]) + nivolumab. SECONDARY OBJECTIVES: I. To investigate the safety and feasibility of radioembolization and nivolumab in patients with HCC with intent for resection. II. To assess the pattern of recurrence post-resection (time frame and location of recurrence). III. To evaluate efficacy in patients with HCC treated with Y90 + nivolumab using overall survival. IV. To evaluate the drop-out rate and incremental changes in future liver remnant (FLR). EXPLORATORY OBJECTIVES: I. To assess immune-related biomarkers from original tumor biopsy if available. II. To identify differences in immunological profiles among patients who go undergo resection versus those who do not undergo resection due to progression or failure to grow FLR to sufficient level. III. In patients with hepatitis C virus (HCV), will explore changes in immunological profile associated with direct acting anti-viral agents. OUTLINE: Patients receive standard of care yttrium Y 90 glass microspheres intravenously (IV). Within 1-2 weeks of completing of yttrium-90 treatment, patients receive nivolumab IV over 30 minutes on day 1. Treatment repeats every 2 weeks for up to 4 doses in the absence of disease progression or unacceptable toxicity. If imaging shows adequate FLR and at least stable disease, patients will undergo resection within 2 weeks after the last dose of nivolumab. Patients who do not complete resection due to feasibility and have progressed or have evidence of high-risk explant may continue to receive nivolumab IV every 2 weeks for up to 1 year. After completion of study treatment, patients are followed up at 30 days and then periodically for up to 3 years.

Conditions

• Hepatocellular Carcinoma

Interventions

Type	Name	Description
BIOLOGICAL	Nivolumab	Given IV
RADIATION	Yttrium Y 90 Glass Microspheres	Given IV

Timeline

• Start date: 2019-02-07
• Primary completion: 2023-10-19
• Completion: 2023-10-19
• First posted: 2019-01-23
• Last updated: 2024-02-21

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study