A Study of Relatlimab Plus Nivolumab Versus Nivolumab Alone in Participants With Advanced Melanoma

Summary

The purpose of this study is to determine whether relatlimab in combination with nivolumab is more effective than nivolumab monotherapy in treating unresectable melanoma or melanoma that has spread.

Timeline

Start

2018-04-11

Primary completion

2021-01-25

Completion

2030-12-15

Publications

• Bautista J, Echeverria CE, Maldonado-Noboa I, Adatty-Molina J, Suarez Urresta S, Coral-Riofrio EC, Araujo-Abad S, Kyriakidis NC, Lopez-Cortes A. Next-Generation Immune Checkpoints and Tumor Microenvironment Modulation in Cancer Immunotherapy. J Immunol Res. 2026;2026(1):e7864229. doi: 10.1155/jimr/7864229.
• Regan MM, Ascierto PA MD, Lipson EJ, Palaia J, Moshyk A, Selvan A, Lao CD, Atkins MB MD, McDermott DF, Potluri R, Ranjan S, Bilthare S, Long GV, Stephen Hodi F, Tawbi H, Schadendorf D. Analysis of treatment-free survival of patients with advanced melanoma receiving nivolumab as monotherapy or in combination with relatlimab in RELATIVITY-047. J Immunother Cancer. 2025 Sep 12;13(9):e012747. doi: 10.1136/jitc-2025-012747.
• Lipson EJ, Stephen Hodi F, Tawbi H, Schadendorf D, Ascierto PA, Matamala L, Gutierrez EC, Rutkowski P, Gogas HJ, Lao CD, Menezes JJ, Dalle S, Arance A, Gaudy-Marqueste C, Chen B, Jackson W, Mukherjee S, Dolfi S, Long GV. Nivolumab plus relatlimab in advanced melanoma: RELATIVITY-047 4-year update. Eur J Cancer. 2025 Jul 25;225:115547. doi: 10.1016/j.ejca.2025.115547. Epub 2025 Jun 3.
• Tawbi HA, Hodi FS, Lipson EJ, Schadendorf D, Ascierto PA, Matamala L, Castillo Gutierrez E, Rutkowski P, Gogas H, Lao CD, Janoski De Menezes J, Dalle S, Arance AM, Grob JJ, Ratto B, Rodriguez S, Mazzei A, Dolfi S, Long GV. Three-Year Overall Survival With Nivolumab Plus Relatlimab in Advanced Melanoma From RELATIVITY-047. J Clin Oncol. 2025 May;43(13):1546-1552. doi: 10.1200/JCO.24.01124. Epub 2024 Dec 13.
• Long GV, Stephen Hodi F, Lipson EJ, Schadendorf D, Ascierto PA, Matamala L, Salman P, Castillo Gutierrez E, Rutkowski P, Gogas HJ, Lao CD, Janoski De Menezes J, Dalle S, Arance A, Grob JJ, Keidel S, Shaikh A, Sobiesk AM, Dolfi S, Tawbi HA. Overall Survival and Response with Nivolumab and Relatlimab in Advanced Melanoma. NEJM Evid. 2023 Apr;2(4):EVIDoa2200239. doi: 10.1056/EVIDoa2200239. Epub 2023 Mar 22.
• Schadendorf D, Tawbi H, Lipson EJ, Stephen Hodi F, Rutkowski P, Gogas H, Lao CD, Grob JJ, Moshyk A, Lord-Bessen J, Hamilton M, Guo S, Shi L, Keidel S, Long GV. Health-related quality of life with nivolumab plus relatlimab versus nivolumab monotherapy in patients with previously untreated unresectable or metastatic melanoma: RELATIVITY-047 trial. Eur J Cancer. 2023 Jul;187:164-173. doi: 10.1016/j.ejca.2023.03.014. Epub 2023 Mar 22.
• Raschi E, Comito F, Massari F, Gelsomino F. Relatlimab and nivolumab in untreated advanced melanoma: insight into RELATIVITY. Immunotherapy. 2023 Feb;15(2):85-91. doi: 10.2217/imt-2022-0172. Epub 2023 Jan 11.
• Tawbi HA, Schadendorf D, Lipson EJ, Ascierto PA, Matamala L, Castillo Gutierrez E, Rutkowski P, Gogas HJ, Lao CD, De Menezes JJ, Dalle S, Arance A, Grob JJ, Srivastava S, Abaskharoun M, Hamilton M, Keidel S, Simonsen KL, Sobiesk AM, Li B, Hodi FS, Long GV; RELATIVITY-047 Investigators. Relatlimab and Nivolumab versus Nivolumab in Untreated Advanced Melanoma. N Engl J Med. 2022 Jan 6;386(1):24-34. doi: 10.1056/NEJMoa2109970.

Drugs

Indications