A Study of IO102/IO103, Nivolumab, and Relatlimab in People With Melanoma
NCT05912244 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 43
Last updated 2026-02-17
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
Interventions
- 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.
Sponsors & Collaborators
-
IO Biotech
collaborator INDUSTRY -
Memorial Sloan Kettering Cancer Center
lead OTHER
Principal Investigators
-
James Smithy, MD · Memorial Sloan Kettering Cancer Center
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SEQUENTIAL
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2023-06-09
- Primary Completion
- 2027-06-09
- Completion
- 2027-06-09
- FDA Drug
- Yes
Countries
- United States
Study Locations
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