NCT03528408

Study of Adjuvant Ipilimumab and Nivolumab in Subjects With High-risk Ocular Melanoma

Phase II Single-arm Multi-center Study of Adjuvant Ipilimumab in Combination With Nivolumab in Subjects With High-risk Ocular Melanoma

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 52 (actual)
• Sponsor: Suthee Rapisuwon · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

This is an open-label, multi-site, single-arm Phase 2 study of adjuvant nivolumab combined with ipilimumab for the treatment of adult subjects with completely treated high-risk ocular melanoma, as defined in eligibility criteria, without evidence of metastatic disease. All patients enrolled to the study will be treated with nivolumab 240 mg IV every 2 weeks plus ipilimumab 1mg/kg IV every 6 weeks. 1 cycle = 6 weeks. Treatment will continue until disease progression, unacceptable toxicity, patient request to discontinue or completion of treatment. Subjects may receive up to 25 doses of nivolumab and 8 doses of ipilimumab

Conditions

• Melanoma
• Ocular Melanoma

Interventions

Type	Name	Description
DRUG	Nivolumab	Nivolumab 240 mg IV over 30 minutes given Day 1, 15 and 29 of each Cycle
DRUG	Ipilimumab	Ipilimumab 1 mg/kg IV over 60 minutes given Day 1 of each Cycle

Timeline

• Start date: 2018-07-26
• Primary completion: 2023-05-01
• Completion: 2023-06-01
• First posted: 2018-05-17
• Last updated: 2023-04-11

Locations

6 sites across 1 country: United States

Regulatory

• FDA-regulated drug study