NCT05912244

A Study of IO102/IO103, Nivolumab, and Relatlimab in People With Melanoma

A Phase II Study of IO102/IO103 and Nivolumab-relatlimab Fixed Dose Combination in Untreated, Unresectable Stage III/IV Melanoma

• Status: Active Not Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 43 (actual)
• Sponsor: Memorial Sloan Kettering Cancer Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The researchers are doing this study to find out whether the study vaccines, IO102/IO103, given in combination with the standard-of-care drug combination, nivolumab and relatlimab, is a safe and effective treatment for people with untreated, unresectable melanoma.

Conditions

• Melanoma

Interventions

Type	Name	Description
DRUG	IO102/IO103	IO102/IO103 will be administered subcutaneously on Days 1 and 15 of the first two 28-day cycles, and then on Day 1 only of subsequent cycles for two total years of treatment. Each vaccine contains 85ug.
DRUG	Nivolumab-Relatlimab	Nivolumab-relatlimab will be administered as a single infusion 160mg relatlimab and nivolumab 480 mg for all participants. Both agents will be combined in a single fixed-dose combination (FDC) as an intravenous 30-minute infusion every four weeks.

Timeline

• Start date: 2023-06-09
• Primary completion: 2027-06-09
• Completion: 2027-06-09
• First posted: 2023-06-22
• Last updated: 2026-02-17

Locations

9 sites across 1 country: United States

Regulatory

• FDA-regulated drug study