Evidence map›Paper›PMID 36780608›Full record

ArticleJournal of clinical oncology : official journal of the American Society of Clinical Oncology2023

Nivolumab and Relatlimab in Patients With Advanced Melanoma That Had Progressed on Anti-Programmed Death-1/Programmed Death Ligand 1 Therapy: Results From the Phase I/IIa RELATIVITY-020 Trial.

Paolo Antonio Ascierto, Evan J Lipson, Reinhard Dummer, James Larkin, Georgina V Long, Rachel E Sanborn, Vanna Chiarion-Sileni, Brigitte Dréno, Stéphane Dalle, Dirk Schadendorf and 12 more

Registry-linked trialOpen access · hybridAbstract read
In one paragraph

Article in Journal of clinical oncology : official journal of the American Society of Clinical Oncology, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT06365619 (Phase II Study of Neoadjuvant Ipilimumab/Nivolumab for Patients With Recurrent, High Risk, Resectable Melanoma), which is not on this map. Cited by 103 papers, 5 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
103citing papers in PubMed, 5 pooled it
32.7field-weighted citation impact, top 1% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT06365619 phase2recruitingnot on this mapstarted 2026, after this paper: background citation

Phase II Study of Neoadjuvant Ipilimumab/Nivolumab for Patients With Recurrent, High Risk, Resectable Melanoma

TypeinterventionalSponsorUniversity of UtahRan2026 to 2030Enrolled25ConditionsMelanomaArmsIpilimumab, Nivolumab
3 · Its place in the literature

Who cites it

103 citing papers in PubMed, 5 syntheses or guidelines pooled it, 144 citations in OpenAlex.

  1. Pooled it
  2. Pooled it
  3. Cutaneous melanoma: ESMO Clinical Practice Guideline for diagnosis, treatment and follow-up.Annals of oncology : official journal of the European Society for Medical Oncology · 2025
    Guideline
  4. Pooled it
  5. Guideline
  6. Trial
  7. FDA Approval Summary: Lifileucel for Unresectable or Metastatic Melanoma Previously Treated with an Anti-PD-1-Based Immunotherapy.Clinical cancer research : an official journal of the American Association for Cancer Research · 2025
    Trial
  8. Trial
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  10. Trial
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  14. First-Line Nivolumab and Relatlimab Plus Chemotherapy for Gastric or Gastroesophageal Junction Adenocarcinoma: The Phase II RELATIVITY-060 Study.Journal of clinical oncology : official journal of the American Society of Clinical Oncology · 2024
    Trial
  15. Trial
  16. Article
  17. Review
  18. Review
  19. Review
  20. Review

43 more citing papers are in PubMed but not listed here.

4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

22 authors at 17 institutions in 8 countries.

Paolo Antonio AsciertoMelanoma, Cancer Immunotherapy, and Development Therapeutics Unit, Istituto Nazionale Tumori IRCCS "Fondazione G. Pascale," Naples, Italy.ORCID 0000-0002-8322-475X
Evan J LipsonSidney Kimmel Comprehensive Cancer Center, Bloomberg-Kimmel Institute for Cancer Immunotherapy, Johns Hopkins University School of Medicine, Baltimore, MD.ORCID 0000-0003-2976-0911
Reinhard DummerDepartment of Dermatology, University of Zurich, Zurich, Switzerland.ORCID 0000-0002-2279-6906
James LarkinMedical Oncology, The Institute of Cancer Research, London, London, UK.ORCID 0000-0001-5569-9523
Georgina V LongMelanoma Institute Australia, The University of Sydney, Royal North Shore and Mater Hospitals, Sydney, NSW, Australia.ORCID 0000-0001-8894-3545
Rachel E SanbornEarle A. Chiles Research Institute, Providence Cancer Institute, Portland, OR.ORCID 0000-0003-0542-6054
Vanna Chiarion-SileniMelanoma Oncology Unit, Istituto Oncologico Veneto, IOV-IRCCS, Padua, Italy.ORCID 0000-0001-9191-9124
Brigitte DrénoNantes Université, INSERM, Immunology and New Concepts in ImmunoTherapy, INCIT, UMR 1302, Nantes, France.ORCID 0000-0001-5574-5825
Stéphane DalleUnit of Dermatology, Hospices Civils de Lyon, Cancer Research Center of Lyon, Pierre-Bénite, France.
Dirk SchadendorfDepartment of Dermatology, University Hospital Essen, and the German Cancer Consortium, Essen, Germany.ORCID 0000-0003-3524-7858
Margaret K CallahanImmunotherapeutics Program, Memorial Sloan Kettering Cancer Center, New York, NY.
Marta NyakasDepartment of Oncology, Oslo University Hospital, Oslo, Norway.ORCID 0000-0001-6331-3440
Victoria AtkinsonGallipoli Medical Research Foundation, Greenslopes Private Hospital, Greenslopes, QLD, Australia.
Carlos Alberto Gomez-RocaDepartment of Medicine & Clinical Research Unit, Institut Universitaire du Cancer de Toulouse Oncopole, Toulouse, France.ORCID 0000-0002-8043-2529
Naoya YamazakiDepartment of Dermatologic Oncology, National Cancer Center Hospital, Tokyo, Japan.ORCID 0000-0002-9638-0428
Hussein A TawbiDepartment of Melanoma Medical Oncology, Division of Cancer Medicine, The University of Texas MD Anderson Cancer Center, Houston, TX.ORCID 0000-0003-1942-851X
Naomey SarkisRelatlimab Clinical Development Melanoma, Bristol Myers Squibb, Princeton, NJ.ORCID 0000-0003-3842-9710
Deepti WaradRelatlimab Clinical Development Melanoma, Bristol Myers Squibb, Princeton, NJ.ORCID 0000-0002-1899-5208
Sonia DolfiTranslational Medicine, Bristol Myers Squibb, Princeton, NJ.
Priyam MitraBiometrics and Data Sciences, Bristol Myers Squibb, Princeton, NJ.
Satyendra SuryawanshiClinical Pharmacology and Pharmacometrics, Bristol Myers Squibb, Princeton, NJ.
Jean-Jacques GrobDermatology, Aix-Marseille University, CHU Timone, Marseille, France.ORCID 0000-0002-0667-153X
Bristol-Myers Squibb (United States) · USAix-Marseille Université · FRBloomberg (United States) · USDeutschen Konsortium für Translationale Krebsforschung · DEGreenslopes Private Hospital · AUHospices Civils de Lyon · FRInserm · FRInstitute of Cancer Research · GBInstitut universitaire du cancer de Toulouse Oncopole · FRIstituto Nazionale Tumori IRCCS "Fondazione G. Pascale" · ITIstituto Oncologico Veneto · ITMemorial Sloan Kettering Cancer Center · USOslo University Hospital · NOProvidence Portland Medical Center · USThe University of Sydney · AUThe University of Texas MD Anderson Cancer Center · USUniversity of Zurich · CH

Funding

X-RAY CRYSTALLOGRAPHYP30CA008748 · NCI · SLOAN-KETTERING INSTITUTE FOR CANCER RES · PI Nicholas D Socci · 1985 to 2026
$347.4M
NCI NIH HHS P30 CA008748
6 · The paper itself

Abstract

purposeNivolumab and relatlimab activity in advanced melanoma with prior progression on anti-programmed death-1/programmed death ligand 1 (PD-(L)1)-containing regimens is under investigation. RELATIVITY-047 demonstrated significantly improved progression-free survival (PFS) for nivolumab and relatlimab over nivolumab in previously untreated advanced melanoma.

methodsThe phase I/IIa, open-label RELATIVITY-020 trial part D assessed efficacy and safety of nivolumab and relatlimab in advanced melanoma with progression during, or within 3 months of, 1 (D1) or ≥ 1 (D2) anti-PD-(L)1-containing regimens. Safety was a primary end point. Objective response rate (coprimary end point) and PFS by blinded independent central review (BICR) were assessed.

resultsFive hundred eighteen patients (D1 = 354; D2 = 164) received nivolumab and relatlimab. Among evaluable patients, the objective response rate by BICR was 12.0% (95% CI, 8.8 to 15.8) in D1 (n = 351) and 9.2% (95% CI, 5.2 to 14.7) in D2 (n = 163). Responses appeared to be enriched among patients with tumors expressing programmed death ligand 1 or lymphocyte activation gene 3; however, responses were observed regardless of programmed death ligand 1 and lymphocyte activation gene 3 expression (1%). The median duration of response was not reached (95% CI, 12.9 to not reached) in D1 and 12.8 months (95% CI, 6.9 to 12.9) in D2. The median PFS by BICR was 2.1 months (95% CI, 1.9 to 3.5) in D1 and 3.2 months (95% CI, 1.9 to 3.6) in D2; the 6-month PFS rate was 29.1% (95% CI, 24.2 to 34.1) and 27.7% (95% CI, 20.5 to 35.4), respectively. The grade 3-4 treatment-related adverse event incidence was 15.0% in D1 and 12.8% in D2. One case of grade 3 myocarditis and no treatment-related deaths occurred across part D.

conclusionNivolumab and relatlimab had a manageable safety profile and demonstrated durable clinical activity in a proportion of patients with heavily pretreated advanced melanoma with prior progression on anti-PD-(L)1-containing regimens. [Media: see text].

Indexed as

MelanomaNivolumabAntibodies, Monoclonal, HumanizedAntineoplastic Combined Chemotherapy ProtocolsB7-H1 AntigenHumansAntibodies, Monoclonal, HumanizedB7-H1 AntigenCD274 protein, humanNivolumabrelatlimab

Identifiers

PMID36780608
PMCPMC10431305
OpenAlexW4320482535

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Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.