---
title: "Relatlimab plus nivolumab 5-year outcomes in advanced melanoma: RELATIVITY-047 survival and biomar"
id: "nature-0-relatlimab-plus-nivolumab-versus-nivolumab-for-advanced-melanoma-5-year"
canonical_url: "https://medichelpline.com/clinical-feed/nature-0-relatlimab-plus-nivolumab-versus-nivolumab-for-advanced-melanoma-5-year"
content_type: "clinical_feed_article"
specialty: "Oncology"
source_name: "Nature Medicine"
source_url: "https://www.nature.com/articles/s41591-026-04756-1"
published_at: "2026-10-24T11:23:43.000Z"
evidence_level: "Journal Feed"
license: "CC-BY-NC-4.0 / Informational Use"
---
# Relatlimab plus nivolumab 5-year outcomes in advanced melanoma: RELATIVITY-047 survival and biomar
## Provenance & Clinical Metadata
- **Canonical URL:** https://medichelpline.com/clinical-feed/nature-0-relatlimab-plus-nivolumab-versus-nivolumab-for-advanced-melanoma-5-year
- **Specialty:** [Oncology](https://medichelpline.com/clinical-feed/oncology.md)
- **Primary Source:** Nature Medicine
- **Source URL:** [Original Journal Publication](https://www.nature.com/articles/s41591-026-04756-1)
- **Published At:** 2026-10-24T11:23:43.000Z
- **Evidence Rating:** Journal Feed
## Executive GIST (TL;DR)
- This report presents the prespecified 5-year analysis of the phase 2–3 RELATIVITY-047 trial comparing **relatlimab** plus **nivolumab** versus **nivolumab** alone in metastatic or unresectable melanoma. - Patients were randomized 1:1 to combination therapy (nivolumab 480 mg plus relatlimab 160 mg every 4 weeks; n = 355) or nivolumab 480 mg every 4 weeks (n = 359); the source reported intravenous dosing and randomization but did not provide further dosing adjustments or subsequent therapy details. - The primary endpoint was **progression-free survival** (PFS) by blinded independent central review; secondary endpoints included **overall survival** (OS), response, and safety. - Minimum follow-up for this analysis was 57.3 months; investigators reported continued separation of survival curves favoring the combination for PFS (HR 0.77), OS (HR 0.78) and melanoma-specific survival (MSS; HR 0.71) with 95% confidence intervals provided in the source. - Safety signals remained consistent with prior reports; the source stated no new safety trends at 5 years but did not enumerate specific adverse event rates in this summary. - Biomarker analyses focused on programmed death ligand 1 (PD-L1) subgroups and LAG-3+ CD8 cell levels; among PD-L1 ≥1% patients, high peripheral or tumor **LAG-3**+ CD8 levels associated with worse outcomes on nivolumab monotherapy. - Investigators observed a lower prevalence of primary resistance with the combination compared with nivolumab alone; the authors interpreted this as evidence that **relatlimab** may overcome **LAG-3**–mediated resistance to PD-1 blockade. - The trial carries ClinicalTrials.gov identifier NCT03470922. The source noted this is an early, citable, peer-reviewed accepted version subject to later edits and replacement by the Version of Record.
## Clinical Analysis & Structured Key Points
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[nature](https://www.nature.com/) 2. [nature medicine](https://www.nature.com/nm) 3. [articles](https://www.nature.com/nm/articles?type=article) 4. article Relatlimab plus nivolumab versus nivolumab for advanced melanoma: 5-year survival and biomarker analyses of the phase 3 RELATIVITY-047 trial [ Download PDF ](https://www.nature.com/articles/s41591-026-04756-1_reference.pdf) [ Download PDF ](https://www.nature.com/articles/s41591-026-04756-1_reference.pdf) * Article * [Open access](https://www.springernature.com/gp/open-science/about/the-fundamentals-of-open-access-and-open-research) * Published: 24 October 2026 # Relatlimab plus nivolumab versus nivolumab for advanced melanoma: 5-year survival and biomarker analyses of the phase 3 RELATIVITY-047 trial * [Georgina V. Long](https://www.nature.com/articles/s41591-026-04756-1#auth-Georgina_V_-Long-Aff1) [ORCID: orcid.org/0000-0001-8894-3545](https://orcid.org/0000-0001-8894-3545)[1](https://www.nature.com/articles/s41591-026-04756-1#Aff1) [na1](https://www.nature.com/articles/s41591-026-04756-1#na1), * [Sonia Dolfi](https://www.nature.com/articles/s41591-026-04756-1#auth-Sonia-Dolfi-Aff2)[2](https://www.nature.com/articles/s41591-026-04756-1#Aff2), * [F. Stephen Hodi](https://www.nature.com/articles/s41591-026-04756-1#auth-F__Stephen-Hodi-Aff3)[3](https://www.nature.com/articles/s41591-026-04756-1#Aff3), * [Evan J. Lipson](https://www.nature.com/articles/s41591-026-04756-1#auth-Evan_J_-Lipson-Aff4) [ORCID: orcid.org/0000-0003-2976-0911](https://orcid.org/0000-0003-2976-0911)[4](https://www.nature.com/articles/s41591-026-04756-1#Aff4), * [Dirk Schadendorf](https://www.nature.com/articles/s41591-026-04756-1#auth-Dirk-Schadendorf-Aff5) [ORCID: orcid.org/0000-0003-3524-7858](https://orcid.org/0000-0003-3524-7858)[5](https://www.nature.com/articles/s41591-026-04756-1#Aff5), * [Paolo A. Ascierto](https://www.nature.com/articles/s41591-026-04756-1#auth-Paolo_A_-Ascierto-Aff6-Aff7) [ORCID: orcid.org/0000-0002-8322-475X](https://orcid.org/0000-0002-8322-475X)[6](https://www.nature.com/articles/s41591-026-04756-1#Aff6),[7](https://www.nature.com/articles/s41591-026-04756-1#Aff7), * [Luis Matamala](https://www.nature.com/articles/s41591-026-04756-1#auth-Luis-Matamala-Aff8)[8](https://www.nature.com/articles/s41591-026-04756-1#Aff8), * [Erika Castillo Gutiérrez](https://www.nature.com/articles/s41591-026-04756-1#auth-Erika-Castillo_Guti_rrez-Aff9)[9](https://www.nature.com/articles/s41591-026-04756-1#Aff9), * [Piotr Rutkowski](https://www.nature.com/articles/s41591-026-04756-1#auth-Piotr-Rutkowski-Aff10) [ORCID: orcid.org/0000-0002-8920-5429](https://orcid.org/0000-0002-8920-5429)[10](https://www.nature.com/articles/s41591-026-04756-1#Aff10), * [Helen J. Gogas](https://www.nature.com/articles/s41591-026-04756-1#auth-Helen_J_-Gogas-Aff11) [ORCID: orcid.org/0000-0002-0451-2885](https://orcid.org/0000-0002-0451-2885)[11](https://www.nature.com/articles/s41591-026-04756-1#Aff11), * [Leslie A. Fecher](https://www.nature.com/articles/s41591-026-04756-1#auth-Leslie_A_-Fecher-Aff12)[12](https://www.nature.com/articles/s41591-026-04756-1#Aff12), * [Christopher D. Lao](https://www.nature.com/articles/s41591-026-04756-1#auth-Christopher_D_-Lao-Aff12)[12](https://www.nature.com/articles/s41591-026-04756-1#Aff12), * [Juliana Janoski De Menezes](https://www.nature.com/articles/s41591-026-04756-1#auth-Juliana_Janoski-Menezes-Aff13)[13](https://www.nature.com/articles/s41591-026-04756-1#Aff13), * [Stéphane Dalle](https://www.nature.com/articles/s41591-026-04756-1#auth-St_phane-Dalle-Aff14)[14](https://www.nature.com/articles/s41591-026-04756-1#Aff14), * [Ana Arance](https://www.nature.com/articles/s41591-026-04756-1#auth-Ana-Arance-Aff15) [ORCID: orcid.org/0000-0003-2896-1957](https://orcid.org/0000-0003-2896-1957)[15](https://www.nature.com/articles/s41591-026-04756-1#Aff15), * [Caroline Gaudy-Marqueste](https://www.nature.com/articles/s41591-026-04756-1#auth-Caroline-Gaudy_Marqueste-Aff16)[16](https://www.nature.com/articles/s41591-026-04756-1#Aff16), * [Emilio Murillo](https://www.nature.com/articles/s41591-026-04756-1#auth-Emilio-Murillo-Aff17)[17](https://www.nature.com/articles/s41591-026-04756-1#Aff17), * [Michele Maio](https://www.nature.com/articles/s41591-026-04756-1#auth-Michele-Maio-Aff18-Aff19)[18](https://www.nature.com/articles/s41591-026-04756-1#Aff18),[19](https://www.nature.com/articles/s41591-026-04756-1#Aff19), * [Maximilian Rohde](https://www.nature.com/articles/s41591-026-04756-1#auth-Maximilian-Rohde-Aff2) [ORCID: orcid.org/0000-0002-3731-3372](https://orcid.org/0000-0002-3731-3372)[2](https://www.nature.com/articles/s41591-026-04756-1#Aff2), * [Charlie Garnett-Benson](https://www.nature.com/articles/s41591-026-04756-1#auth-Charlie-Garnett_Benson-Aff2) [ORCID: orcid.org/0000-0002-0238-3303](https://orcid.org/0000-0002-0238-3303)[2](https://www.nature.com/articles/s41591-026-04756-1#Aff2), * [Ruiyun Jiang](https://www.nature.com/articles/s41591-026-04756-1#auth-Ruiyun-Jiang-Aff2)[2](https://www.nature.com/articles/s41591-026-04756-1#Aff2), * [Bohang Chen](https://www.nature.com/articles/s41591-026-04756-1#auth-Bohang-Chen-Aff2)[2](https://www.nature.com/articles/s41591-026-04756-1#Aff2), * [Jia Xin Yu](https://www.nature.com/articles/s41591-026-04756-1#auth-Jia_Xin-Yu-Aff2) [ORCID: orcid.org/0000-0002-3319-5997](https://orcid.org/0000-0002-3319-5997)[2](https://www.nature.com/articles/s41591-026-04756-1#Aff2), * [Travis Hollmann](https://www.nature.com/articles/s41591-026-04756-1#auth-Travis-Hollmann-Aff2)[2](https://www.nature.com/articles/s41591-026-04756-1#Aff2), * [Gabriele Zuchtriegel](https://www.nature.com/articles/s41591-026-04756-1#auth-Gabriele-Zuchtriegel-Aff20)[20](https://www.nature.com/articles/s41591-026-04756-1#Aff20) & * … * [Hussein Tawbi](https://www.nature.com/articles/s41591-026-04756-1#auth-Hussein-Tawbi-Aff21) [ORCID: orcid.org/0000-0003-1942-851X](https://orcid.org/0000-0003-1942-851X)[21](https://www.nature.com/articles/s41591-026-04756-1#Aff21) [na1](https://www.nature.com/articles/s41591-026-04756-1#na1) Show authors [_Nature Medicine_](https://www.nature.com/nm) (2026) [Cite this article](https://www.nature.com/articles/s41591-026-04756-1#citeas) Save article [ View saved research ](https://www.nature.com/saved-research) We’re sharing this article early to provide faster access to peer-reviewed, accepted research. It is citable and carries a permanent DOI. This version is subject to further edits and will be replaced automatically by the final Version of Record. All legal disclaimers apply. ## Abstract Nivolumab plus relatlimab is approved for advanced melanoma based on the RELATIVITY-047 trial; however, long-term data are needed. Here, we report data from RELATIVITY-047 with the longest follow-up at present. In this phase 2–3, double-blind trial, patients with metastatic/unresectable melanoma were randomized 1:1 to nivolumab 480 mg plus relatlimab 160 mg (_n_ = 355) or nivolumab 480 mg (_n_ = 359) intravenously every 4 weeks. The primary endpoint was progression-free survival (PFS) by blinded independent central review. Secondary endpoints were overall survival (OS), response, and safety. Additional post-hoc analyses such as melanoma-specific survival (MSS), and exploratory biomarker analyses are also reported. This analysis shows clear separation in survival curves with the largest absolute differences to date in PFS, OS, and MSS. In this prespecified 5-year analysis, with a minimum follow-up of 57.3 months, nivolumab plus relatlimab demonstrated continued clinically significant benefit versus nivolumab for PFS (hazard ratio = 0.77; 95% confidence interval: 0.65–0.92), OS (hazard ratio = 0.78; 95% confidence interval: 0.64–0.95), and MSS (hazard ratio = 0.71; 95% confidence interval: 0.57–0.88). The safety profile remained consistent with prior reports. Among biomarker-evaluable patients in the programmed death ligand 1 ≥1% subgroup, analyses revealed an association between worse outcomes with nivolumab and high peripheral or tumor lymphocyte activation gene 3 (LAG-3)+ CD8 cell levels. The addition of relatlimab to nivolumab was associated with a lower prevalence of primary resistance than nivolumab alone. These data support the hypothesis that relatlimab can overcome LAG-3–mediated resistance to nivolumab and provides evidence for differential efficacy patterns observed across biomarker subgroups linked to primary versus acquired resistance states. ClinicalTrials.gov identifier: [NCT03470922](https://clinicaltrials.gov/study/NCT03470922). ### Explore related subjects Discover the latest articles and news in related subjects. * [Biomarkers](https://www.nature.com/subjects/biomarkers) * [Cancer](https://www.nature.com/subjects/cancer) * [Immunotherapy Strategies in Advanced Melanoma](https://www.nature.com/subjects/immunotherapy-strategies-in-advanced-melanoma) ## Author information Author notes 1. These authors contributed equally: Georgina V. Long, Hussein Tawbi. ### Authors and Affiliations 1. Melanoma Institute Australia, The University of Sydney, Royal North Shore and Mater Hospitals, Sydney, NSW, Australia Georgina V. Long 2. Bristol Myers Squibb, Princeton, NJ, USA Sonia Dolfi, Maximilian Rohde, Charlie Garnett-Benson, Ruiyun Jiang, Bohang Chen, Jia Xin Yu & Travis Hollmann 3. Department of Medical Oncology, Dana-Farber Cancer Institute, Boston, MA, USA F. Stephen Hodi 4. Department of Oncology, The Bloomberg-Kimmel Institute for Cancer Immunotherapy, Johns Hopkins University School of Medicine, The Sidney Kimmel Comprehensive Cancer Center, Baltimore, MD, USA Evan J. Lipson 5. Department of Dermatology, University Hospital Essen; & German Cancer Consortium, Campus Essen & National Center for Tumor Diseases (NCT-West), Campus Essen, and Research Alliance Ruhr, Research Center One Health, University Duisburg-Essen, Campus Essen, Essen, Germany Dirk Schadendorf 6. University of Naples Federico II, Naples, Italy Paolo A. Ascierto 7. Department of Melanoma, Cancer Immunotherapy and Development Therapeutics, Istituto Nazionale Tumori IRCCS Fondazione G. Pascale, Naples, Italy Paolo A. Ascierto 8. Department of Oncology, Instituto Oncológico Fundación Arturo López Pérez and Department of Oncology, Instituto Nacional del Cáncer, Santiago, Chile Luis Matamala 9. Department of Oncology, FAICIC Clinical Research, Veracruz, Mexico Erika Castillo Gutiérrez 10. Department of Soft Tissue/Bone Sarcoma and Melanoma, Maria Skłodowska-Curie National Research Institute of Oncology, Warsaw, Poland Piotr Rutkowski 11. Department of Medicine, National and Kapodistrian University of Athens, Athens, Greece Helen J. Gogas 12. Department of Internal Medicine, Michigan Medicine, Rogel Cancer Center, University of Michigan, Ann Arbor, MI, USA Leslie A. Fecher & Christopher D. Lao 13. Department of Clinical Oncology, Hospital Nossa Senhora da Conceição, Porto Alegre, Brazil Juliana Janoski De Menezes 14. Department of Dermatology, Hospices Civils de Lyon, Cancer Research Center of Lyon, Pierre-Bénite, France Stéphane Dalle 15. Medical Oncology Department, Hospital Clinic de Barcelona and IDIBAPS, Barcelona, Spain Ana Arance 16. Aix-Marseille University, APHM, CHU Timone, Dermatology and Skin Cancer Department, Marseille, France Caroline Gaudy-Marqueste 17. Departmentof Oncology, iBiomed Clinical Research, Guadalajara, Mexico Emilio Murillo 18. University of Siena, Siena, Italy Michele Maio 19. Center for Immuno-Oncology, Department of Oncology, University Hospital, Siena, Italy Michele Maio 20. Bristol Myers Squibb, Boudry, Switzerland Gabriele Zuchtriegel 21. Department of Melanoma Medical Oncology, The University of Texas MD Anderson Cancer Center, Houston, TX, USA Hussein Tawbi Authors 1. Georgina V. Long [View author publications](https://www.nature.com/search?author=Georgina%20V.%20Long) Search author on:[PubMed](https://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=search&term=Georgina%20V.%20Long)[Google Scholar](https://scholar.google.co.uk/scholar?as_q=&num=10&btnG=Search+Scholar&as_epq=&as_oq=&as_eq=&as_occt=any&as_sauthors=%22Georgina%20V.%20Long%22&as_publication=&as_ylo=&as_yhi=&as_allsubj=all&hl=en) 2. Sonia Dolfi [View author publications](https://www.nature.com/search?author=Sonia%20Dolfi) Search author on:[PubMed](https://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=search&term=Sonia%20Dolfi)[Google Scholar](https://scholar.google.co.uk/scholar?as_q=&num=10&btnG=Search+Scholar&as_epq=&as_oq=&as_eq=&as_occt=any&as_sauthors=%22Sonia%20Dolfi%22&as_publication=&as_ylo=&as_yhi=&as_allsubj=all&hl=en) 3. F. Stephen Hodi [View author publications](https://www.nature.com/search?author=F.%20Stephen%20Hodi) Search author on:[PubMed](https://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=search&term=F.%20Stephen%20Hodi)[Google Scholar](https://scholar.google.co.uk/scholar?as_q=&num=10&btnG=Search+Scholar&as_epq=&as_oq=&as_eq=&as_occt=any&as_sauthors=%22F.%20Stephen%20Hodi%22&as_publication=&as_ylo=&as_yhi=&as_allsubj=all&hl=en) 4. Evan J. Lipson [View author publications](https://www.nature.com/search?author=Evan%20J.%20Lipson) Search author on:[PubMed](https://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=search&term=Evan%20J.%20Lipson)[Google Scholar](https://scholar.google.co.uk/scholar?as_q=&num=10&btnG=Search+Scholar&as_epq=&as_oq=&as_eq=&as_occt=any&as_sauthors=%22Evan%20J.%20Lipson%22&as_publication=&as_ylo=&as_yhi=&as_allsubj=all&hl=en) 5. Dirk Schadendorf [View author publications](https://www.nature.com/search?author=Dirk%20Schadendorf) Search author on:[PubMed](https://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=search&term=Dirk%20Schadendorf)[Google Scholar](https://scholar.google.co.uk/scholar?as_q=&num=10&btnG=Search+Scholar&as_epq=&as_oq=&as_eq=&as_occt=any&as_sauthors=%22Dirk%20Schadendorf%22&as_publication=&as_ylo=&as_yhi=&as_allsubj=all&hl=en) 6. Paolo A. Ascierto [View author publications](https://www.nature.com/search?author=Paolo%20A.%20Ascierto) Search author on:[PubMed](https://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=search&term=Paolo%20A.%20Ascierto)[Google Scholar](https://scholar.google.co.uk/scholar?as_q=&num=10&btnG=Search+Scholar&as_epq=&as_oq=&as_eq=&as_occt=any&as_sauthors=%22Paolo%20A.%20Ascierto%22&as_publication=&as_ylo=&as_yhi=&as_allsubj=all&hl=en) 7. 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