drugset / Trial / NCT05912244
A Study of IO102/IO103, Nivolumab, and Relatlimab in People With Melanoma
Phase 2
Active not recruiting
43 enrolled
Memorial Sloan Kettering Cancer Center
IO Biotech · collab
NaSequentialOpen-labelTreatment
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.
Timeline
- Start
- 2023-06-09
- Primary completion
- 2027-06-09
- Completion
- 2027-06-09
Publications
- Background Kjeldsen JW, Lorentzen CL, Martinenaite E, Ellebaek E, Donia M, Holmstroem RB, Klausen TW, Madsen CO, Ahmed SM, Weis-Banke SE, Holmstrom MO, Hendel HW, Ehrnrooth E, Zocca MB, Pedersen AW, Andersen MH, Svane IM. A phase 1/2 trial of an immune-modulatory vaccine against IDO/PD-L1 in combination with nivolumab in metastatic melanoma. Nat Med. 2021 Dec;27(12):2212-2223. doi: 10.1038/s41591-021-01544-x. Epub 2021 Dec 9.
- Background Lorentzen CL, Kjeldsen JW, Ehrnrooth E, Andersen MH, Marie Svane I. Long-term follow-up of anti-PD-1 naive patients with metastatic melanoma treated with IDO/PD-L1 targeting peptide vaccine and nivolumab. J Immunother Cancer. 2023 May;11(5):e006755. doi: 10.1136/jitc-2023-006755.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | IMSAPEPIMUT | Peptide | 85 ug | Subcutaneous |
| Subject | IO103 | Vaccine | 85 ug | Subcutaneous |
| Subject | Nivolumab | Monoclonal antibody | 480 mg | Intravenous |
| Subject | Relatlimab | Monoclonal antibody | 160 mg | Intravenous |