NCT03472586

Ipilimumab and Nivolumab With Immunoembolization in Treating Participants With Metastatic Uveal Melanoma in the Liver

Ipilimumab and Nivolumab in Combination With Immunoembolization for the Treatment of Metastatic Uveal Melanoma

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 14 (actual)
• Sponsor: Sidney Kimmel Comprehensive Cancer Center at Thomas Jefferson University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This phase II trial studies ipilimumab and nivolumab with immunoembolization in treating patients with uveal melanoma that has spread to the liver. Immunotherapy with monoclonal antibodies, such as ipilimumab and nivolumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Immunoembolization may kill tumor cells due to loss of blood supply and develop an immune response against tumor cells. Giving ipilimumab and nivolumab with immunoembolization may work better in treating patients with uveal melanoma.

Detailed description

PRIMARY OBJECTIVES: I. Determine the clinical benefit of treatment with immunoembolization (IEMBO) in combination with ipilimumab and nivolumab. SECONDARY OBJECTIVES: I. Determine all treatment and immune related toxicities. II. Determine progression free survival. III. Determine overall survival.

Conditions

• Metastatic Malignant Neoplasm in the Liver
• Metastatic Uveal Melanoma
• Stage IV Uveal Melanoma AJCC v7

Interventions

Type	Name	Description
BIOLOGICAL	Ipilimumab	Given IV
BIOLOGICAL	Nivolumab	Given IV
DRUG	Embolization Therapy	Undergo immunoembolization

Timeline

• Start date: 2018-05-02
• Primary completion: 2022-12-31
• Completion: 2024-12-31
• First posted: 2018-03-21
• Last updated: 2025-04-24
• Results posted: 2023-11-29

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study