NCT03922880

Study of Immunotherapy Plus ADI-PEG 20 for the Treatment of Advanced Uveal Melanoma

Pilot Study Combining Arginine Depletion and Checkpoint Inhibition in Uveal Melanomas

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 9 (actual)
• Sponsor: Memorial Sloan Kettering Cancer Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This study is measuring the safety of the study drug, ADI-PEG 20, combined with immunotherapy drugs nivolumab and ipilimumab in treating patients with advanced uveal melanoma.

Conditions

• Uveal Melanoma

Interventions

Type	Name	Description
DRUG	ADI PEG20	ADI-PEG 20 will be administered at a dose of 36mg/m2 intramuscularly once a week.
DRUG	Nivolumab	Nivolumab 240mg + Ipilimumab 1mg/kg for up to 8 total doses of ipilimumab. One ipilimumab has completed, nivolumab 480mg will be given every 4 weeks.
DRUG	Ipilimumab	Ipilimumab 1mg/kg with Nivolumab 240mg for up to 8 total doses of ipilimumab. The first four doses of ipilimumab will be scheduled once every 3 weeks. The 5th-8th doses of ipilimumab will be scheduled once every 6 weeks with nivoumab 240mg every 3 weeks.

Timeline

• Start date: 2019-04-16
• Primary completion: 2023-01-20
• Completion: 2023-01-20
• First posted: 2019-04-22
• Last updated: 2025-05-15

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study