Evidence map›Paper›PMID 34986285›Full record

Trial reportThe New England journal of medicine2022

Relatlimab and Nivolumab versus Nivolumab in Untreated Advanced Melanoma.

Hussein A Tawbi, Dirk Schadendorf, Evan J Lipson, Paolo A Ascierto, Luis Matamala, Erika Castillo Gutiérrez, Piotr Rutkowski, Helen J Gogas, Christopher D Lao, Juliana Janoski De Menezes and 13 more

4 registry-linked trialsOpen access · bronzeAbstract readClinical Trial, Phase IIClinical Trial, Phase IIIComparative Study
PubMed Full text at PMC Publisher
In one paragraph

Trial report in The New England journal of medicine, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 4 registered trials, which are not on this map. Cited by 1,188 papers, 4 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
1,188citing papers in PubMed, 4 pooled it
166.2field-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.

NCT03470922 phase2 / phase3active not recruitingnot on this map

A Randomized, Double-Blind Phase 2/3 Study of Relatlimab Combined With Nivolumab Versus Nivolumab in Participants With Previously Untreated Metastatic or Unresectable Melanoma

TypeinterventionalSponsorBristol-Myers SquibbRan2018 to 2030Enrolled714ConditionsMelanomaArmsRelatlimab, Nivolumab
NCT06494943 phase1 / phase2recruitingnot on this mapstarted 2024, after this paper: background citation

Neoadjuvant IBI110 and Sintilimab in Combination with Chemotherapy in Resectable Locally Advanced Head and Neck Squamous Cell Carcinoma (HNSCC)- a Phase Ib Clinical Trial

TypeinterventionalSponsorFudan UniversityRan2024 to 2028Enrolled27ConditionsHead and Neck Cancer, Head and Neck Squamous Cell CarcinomaArmsSintilimab, IBI110, Paclitaxel, Cis Platinum, Surgery
NCT06865339 phase2recruitingnot on this mapstarted 2025, after this paper: background citation

TRIPL: Thoracic Radiotherapy and Inhibition of PD-1 and LAG-3 for Locally Advanced Non-Small Cell Lung Cancer

TypeinterventionalSponsorMontefiore Medical CenterRan2025 to 2027Enrolled76ConditionsNSCLC, Locally AdvancedArmsCemiplimab, Fianlimab, Radiotherapy, Platinum Doublet Chemotherapy (PDC)
NCT06887088 phase2recruitingnot on this mapstarted 2025, after this paper: background citation

Phase II, Single Arm, Multicentre Clinical Trial to Evaluate the Activity of Encorafenib Plus Binimetinib Followed by Cemiplimab And Fianlimab in Patients With BRAF Mutated Melanoma and Symptomatic Brain Metastases

TypeinterventionalSponsorGrupo Español Multidisciplinar de MelanomaRan2025 to 2028Enrolled33ConditionsMelanoma BRAF V600E/K Mutated, Melanoma and Brain MetastasesArmsEncorafenib + Binimetinib, cemiplimab+fianlimab
3 · Its place in the literature

Who cites it

1,188 citing papers in PubMed, 4 syntheses or guidelines pooled it, 1,676 citations in OpenAlex.

  1. Pooled it
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  9. Anti-LAG-3 Antibody LBL-007 plus Tislelizumab and Chemotherapy as First-Line Therapy for Advanced Nasopharyngeal Carcinoma: A Multicenter Phase 2 Trial.Clinical cancer research : an official journal of the American Association for Cancer Research · 2026
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  14. Type 3 Autoimmune Pancreatitis: What Do We Know So Far?Digestive diseases and sciences · 2026
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1,128 more citing papers are in PubMed but not listed here.

4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

23 authors at 1 institution in 1 country.

Hussein A TawbiFrom the Department of Melanoma Medical Oncology, Division of Cancer Medicine, University of Texas M.D. Anderson Cancer Center, Houston (H.A.T.); the Department of Dermatology, University Hospital Essen, and the German Cancer Consortium, Essen, Germany (D.S.); the Sidney Kimmel Comprehensive Cancer Center, Bloomberg-Kimmel Institute for Cancer Immunotherapy, Johns Hopkins University School of Medicine, Baltimore (E.J.L.); Istituto Nazionale Tumori IRCCS Fondazione "G. Pascale," Naples, Italy (P.A.A.); the Department of Oncology, Instituto Oncologico Fundacion Arturo Lopez Perez, Santiago, Chile (L.M.); FAICIC Clinical Research, Veracruz, Mexico (E.C.G.); Maria Sklodowska-Curie National Research Institute of Oncology, Warsaw, Poland (P.R.); the Department of Medicine, National and Kapodistrian University of Athens, Athens (H.J.G.); Michigan Medicine, Rogel Cancer Center, University of Michigan, Ann Arbor (C.D.L.); Hospital Nossa Senhora da Conceição, Porto Alegre, Brazil (J.J.D.M.); the Unit of Dermatology, Hospices Civils de Lyon, Cancer Research Center of Lyon, Pierre-Bénite (S.D.), and Aix-Marseille University, CHU Timone, Marseille (J.-J.G.) - both in France; the Department of Medical Oncology, Hospital Clinic Barcelona and IDIBAPS, Barcelona (A.A.); Bristol Myers Squibb, Princeton, NJ (S.S., M.A., M.H., S.K., K.L.S., A.M.S., B.L.); the Dana-Farber Cancer Institute, Boston (F.S.H.); and Melanoma Institute Australia, University of Sydney, Royal North Shore and Mater Hospitals, Sydney (G.V.L.).ORCID 0000-0003-1942-851X
Dirk SchadendorfFrom the Department of Melanoma Medical Oncology, Division of Cancer Medicine, University of Texas M.D. Anderson Cancer Center, Houston (H.A.T.); the Department of Dermatology, University Hospital Essen, and the German Cancer Consortium, Essen, Germany (D.S.); the Sidney Kimmel Comprehensive Cancer Center, Bloomberg-Kimmel Institute for Cancer Immunotherapy, Johns Hopkins University School of Medicine, Baltimore (E.J.L.); Istituto Nazionale Tumori IRCCS Fondazione "G. Pascale," Naples, Italy (P.A.A.); the Department of Oncology, Instituto Oncologico Fundacion Arturo Lopez Perez, Santiago, Chile (L.M.); FAICIC Clinical Research, Veracruz, Mexico (E.C.G.); Maria Sklodowska-Curie National Research Institute of Oncology, Warsaw, Poland (P.R.); the Department of Medicine, National and Kapodistrian University of Athens, Athens (H.J.G.); Michigan Medicine, Rogel Cancer Center, University of Michigan, Ann Arbor (C.D.L.); Hospital Nossa Senhora da Conceição, Porto Alegre, Brazil (J.J.D.M.); the Unit of Dermatology, Hospices Civils de Lyon, Cancer Research Center of Lyon, Pierre-Bénite (S.D.), and Aix-Marseille University, CHU Timone, Marseille (J.-J.G.) - both in France; the Department of Medical Oncology, Hospital Clinic Barcelona and IDIBAPS, Barcelona (A.A.); Bristol Myers Squibb, Princeton, NJ (S.S., M.A., M.H., S.K., K.L.S., A.M.S., B.L.); the Dana-Farber Cancer Institute, Boston (F.S.H.); and Melanoma Institute Australia, University of Sydney, Royal North Shore and Mater Hospitals, Sydney (G.V.L.).ORCID 0000-0003-3524-7858
Evan J LipsonFrom the Department of Melanoma Medical Oncology, Division of Cancer Medicine, University of Texas M.D. Anderson Cancer Center, Houston (H.A.T.); the Department of Dermatology, University Hospital Essen, and the German Cancer Consortium, Essen, Germany (D.S.); the Sidney Kimmel Comprehensive Cancer Center, Bloomberg-Kimmel Institute for Cancer Immunotherapy, Johns Hopkins University School of Medicine, Baltimore (E.J.L.); Istituto Nazionale Tumori IRCCS Fondazione "G. Pascale," Naples, Italy (P.A.A.); the Department of Oncology, Instituto Oncologico Fundacion Arturo Lopez Perez, Santiago, Chile (L.M.); FAICIC Clinical Research, Veracruz, Mexico (E.C.G.); Maria Sklodowska-Curie National Research Institute of Oncology, Warsaw, Poland (P.R.); the Department of Medicine, National and Kapodistrian University of Athens, Athens (H.J.G.); Michigan Medicine, Rogel Cancer Center, University of Michigan, Ann Arbor (C.D.L.); Hospital Nossa Senhora da Conceição, Porto Alegre, Brazil (J.J.D.M.); the Unit of Dermatology, Hospices Civils de Lyon, Cancer Research Center of Lyon, Pierre-Bénite (S.D.), and Aix-Marseille University, CHU Timone, Marseille (J.-J.G.) - both in France; the Department of Medical Oncology, Hospital Clinic Barcelona and IDIBAPS, Barcelona (A.A.); Bristol Myers Squibb, Princeton, NJ (S.S., M.A., M.H., S.K., K.L.S., A.M.S., B.L.); the Dana-Farber Cancer Institute, Boston (F.S.H.); and Melanoma Institute Australia, University of Sydney, Royal North Shore and Mater Hospitals, Sydney (G.V.L.).
Paolo A AsciertoFrom the Department of Melanoma Medical Oncology, Division of Cancer Medicine, University of Texas M.D. Anderson Cancer Center, Houston (H.A.T.); the Department of Dermatology, University Hospital Essen, and the German Cancer Consortium, Essen, Germany (D.S.); the Sidney Kimmel Comprehensive Cancer Center, Bloomberg-Kimmel Institute for Cancer Immunotherapy, Johns Hopkins University School of Medicine, Baltimore (E.J.L.); Istituto Nazionale Tumori IRCCS Fondazione "G. Pascale," Naples, Italy (P.A.A.); the Department of Oncology, Instituto Oncologico Fundacion Arturo Lopez Perez, Santiago, Chile (L.M.); FAICIC Clinical Research, Veracruz, Mexico (E.C.G.); Maria Sklodowska-Curie National Research Institute of Oncology, Warsaw, Poland (P.R.); the Department of Medicine, National and Kapodistrian University of Athens, Athens (H.J.G.); Michigan Medicine, Rogel Cancer Center, University of Michigan, Ann Arbor (C.D.L.); Hospital Nossa Senhora da Conceição, Porto Alegre, Brazil (J.J.D.M.); the Unit of Dermatology, Hospices Civils de Lyon, Cancer Research Center of Lyon, Pierre-Bénite (S.D.), and Aix-Marseille University, CHU Timone, Marseille (J.-J.G.) - both in France; the Department of Medical Oncology, Hospital Clinic Barcelona and IDIBAPS, Barcelona (A.A.); Bristol Myers Squibb, Princeton, NJ (S.S., M.A., M.H., S.K., K.L.S., A.M.S., B.L.); the Dana-Farber Cancer Institute, Boston (F.S.H.); and Melanoma Institute Australia, University of Sydney, Royal North Shore and Mater Hospitals, Sydney (G.V.L.).ORCID 0000-0002-8322-475X
Luis MatamalaFrom the Department of Melanoma Medical Oncology, Division of Cancer Medicine, University of Texas M.D. Anderson Cancer Center, Houston (H.A.T.); the Department of Dermatology, University Hospital Essen, and the German Cancer Consortium, Essen, Germany (D.S.); the Sidney Kimmel Comprehensive Cancer Center, Bloomberg-Kimmel Institute for Cancer Immunotherapy, Johns Hopkins University School of Medicine, Baltimore (E.J.L.); Istituto Nazionale Tumori IRCCS Fondazione "G. Pascale," Naples, Italy (P.A.A.); the Department of Oncology, Instituto Oncologico Fundacion Arturo Lopez Perez, Santiago, Chile (L.M.); FAICIC Clinical Research, Veracruz, Mexico (E.C.G.); Maria Sklodowska-Curie National Research Institute of Oncology, Warsaw, Poland (P.R.); the Department of Medicine, National and Kapodistrian University of Athens, Athens (H.J.G.); Michigan Medicine, Rogel Cancer Center, University of Michigan, Ann Arbor (C.D.L.); Hospital Nossa Senhora da Conceição, Porto Alegre, Brazil (J.J.D.M.); the Unit of Dermatology, Hospices Civils de Lyon, Cancer Research Center of Lyon, Pierre-Bénite (S.D.), and Aix-Marseille University, CHU Timone, Marseille (J.-J.G.) - both in France; the Department of Medical Oncology, Hospital Clinic Barcelona and IDIBAPS, Barcelona (A.A.); Bristol Myers Squibb, Princeton, NJ (S.S., M.A., M.H., S.K., K.L.S., A.M.S., B.L.); the Dana-Farber Cancer Institute, Boston (F.S.H.); and Melanoma Institute Australia, University of Sydney, Royal North Shore and Mater Hospitals, Sydney (G.V.L.).
Erika Castillo GutiérrezFrom the Department of Melanoma Medical Oncology, Division of Cancer Medicine, University of Texas M.D. Anderson Cancer Center, Houston (H.A.T.); the Department of Dermatology, University Hospital Essen, and the German Cancer Consortium, Essen, Germany (D.S.); the Sidney Kimmel Comprehensive Cancer Center, Bloomberg-Kimmel Institute for Cancer Immunotherapy, Johns Hopkins University School of Medicine, Baltimore (E.J.L.); Istituto Nazionale Tumori IRCCS Fondazione "G. Pascale," Naples, Italy (P.A.A.); the Department of Oncology, Instituto Oncologico Fundacion Arturo Lopez Perez, Santiago, Chile (L.M.); FAICIC Clinical Research, Veracruz, Mexico (E.C.G.); Maria Sklodowska-Curie National Research Institute of Oncology, Warsaw, Poland (P.R.); the Department of Medicine, National and Kapodistrian University of Athens, Athens (H.J.G.); Michigan Medicine, Rogel Cancer Center, University of Michigan, Ann Arbor (C.D.L.); Hospital Nossa Senhora da Conceição, Porto Alegre, Brazil (J.J.D.M.); the Unit of Dermatology, Hospices Civils de Lyon, Cancer Research Center of Lyon, Pierre-Bénite (S.D.), and Aix-Marseille University, CHU Timone, Marseille (J.-J.G.) - both in France; the Department of Medical Oncology, Hospital Clinic Barcelona and IDIBAPS, Barcelona (A.A.); Bristol Myers Squibb, Princeton, NJ (S.S., M.A., M.H., S.K., K.L.S., A.M.S., B.L.); the Dana-Farber Cancer Institute, Boston (F.S.H.); and Melanoma Institute Australia, University of Sydney, Royal North Shore and Mater Hospitals, Sydney (G.V.L.).
Piotr RutkowskiFrom the Department of Melanoma Medical Oncology, Division of Cancer Medicine, University of Texas M.D. Anderson Cancer Center, Houston (H.A.T.); the Department of Dermatology, University Hospital Essen, and the German Cancer Consortium, Essen, Germany (D.S.); the Sidney Kimmel Comprehensive Cancer Center, Bloomberg-Kimmel Institute for Cancer Immunotherapy, Johns Hopkins University School of Medicine, Baltimore (E.J.L.); Istituto Nazionale Tumori IRCCS Fondazione "G. Pascale," Naples, Italy (P.A.A.); the Department of Oncology, Instituto Oncologico Fundacion Arturo Lopez Perez, Santiago, Chile (L.M.); FAICIC Clinical Research, Veracruz, Mexico (E.C.G.); Maria Sklodowska-Curie National Research Institute of Oncology, Warsaw, Poland (P.R.); the Department of Medicine, National and Kapodistrian University of Athens, Athens (H.J.G.); Michigan Medicine, Rogel Cancer Center, University of Michigan, Ann Arbor (C.D.L.); Hospital Nossa Senhora da Conceição, Porto Alegre, Brazil (J.J.D.M.); the Unit of Dermatology, Hospices Civils de Lyon, Cancer Research Center of Lyon, Pierre-Bénite (S.D.), and Aix-Marseille University, CHU Timone, Marseille (J.-J.G.) - both in France; the Department of Medical Oncology, Hospital Clinic Barcelona and IDIBAPS, Barcelona (A.A.); Bristol Myers Squibb, Princeton, NJ (S.S., M.A., M.H., S.K., K.L.S., A.M.S., B.L.); the Dana-Farber Cancer Institute, Boston (F.S.H.); and Melanoma Institute Australia, University of Sydney, Royal North Shore and Mater Hospitals, Sydney (G.V.L.).
Helen J GogasFrom the Department of Melanoma Medical Oncology, Division of Cancer Medicine, University of Texas M.D. Anderson Cancer Center, Houston (H.A.T.); the Department of Dermatology, University Hospital Essen, and the German Cancer Consortium, Essen, Germany (D.S.); the Sidney Kimmel Comprehensive Cancer Center, Bloomberg-Kimmel Institute for Cancer Immunotherapy, Johns Hopkins University School of Medicine, Baltimore (E.J.L.); Istituto Nazionale Tumori IRCCS Fondazione "G. Pascale," Naples, Italy (P.A.A.); the Department of Oncology, Instituto Oncologico Fundacion Arturo Lopez Perez, Santiago, Chile (L.M.); FAICIC Clinical Research, Veracruz, Mexico (E.C.G.); Maria Sklodowska-Curie National Research Institute of Oncology, Warsaw, Poland (P.R.); the Department of Medicine, National and Kapodistrian University of Athens, Athens (H.J.G.); Michigan Medicine, Rogel Cancer Center, University of Michigan, Ann Arbor (C.D.L.); Hospital Nossa Senhora da Conceição, Porto Alegre, Brazil (J.J.D.M.); the Unit of Dermatology, Hospices Civils de Lyon, Cancer Research Center of Lyon, Pierre-Bénite (S.D.), and Aix-Marseille University, CHU Timone, Marseille (J.-J.G.) - both in France; the Department of Medical Oncology, Hospital Clinic Barcelona and IDIBAPS, Barcelona (A.A.); Bristol Myers Squibb, Princeton, NJ (S.S., M.A., M.H., S.K., K.L.S., A.M.S., B.L.); the Dana-Farber Cancer Institute, Boston (F.S.H.); and Melanoma Institute Australia, University of Sydney, Royal North Shore and Mater Hospitals, Sydney (G.V.L.).
Christopher D LaoFrom the Department of Melanoma Medical Oncology, Division of Cancer Medicine, University of Texas M.D. Anderson Cancer Center, Houston (H.A.T.); the Department of Dermatology, University Hospital Essen, and the German Cancer Consortium, Essen, Germany (D.S.); the Sidney Kimmel Comprehensive Cancer Center, Bloomberg-Kimmel Institute for Cancer Immunotherapy, Johns Hopkins University School of Medicine, Baltimore (E.J.L.); Istituto Nazionale Tumori IRCCS Fondazione "G. Pascale," Naples, Italy (P.A.A.); the Department of Oncology, Instituto Oncologico Fundacion Arturo Lopez Perez, Santiago, Chile (L.M.); FAICIC Clinical Research, Veracruz, Mexico (E.C.G.); Maria Sklodowska-Curie National Research Institute of Oncology, Warsaw, Poland (P.R.); the Department of Medicine, National and Kapodistrian University of Athens, Athens (H.J.G.); Michigan Medicine, Rogel Cancer Center, University of Michigan, Ann Arbor (C.D.L.); Hospital Nossa Senhora da Conceição, Porto Alegre, Brazil (J.J.D.M.); the Unit of Dermatology, Hospices Civils de Lyon, Cancer Research Center of Lyon, Pierre-Bénite (S.D.), and Aix-Marseille University, CHU Timone, Marseille (J.-J.G.) - both in France; the Department of Medical Oncology, Hospital Clinic Barcelona and IDIBAPS, Barcelona (A.A.); Bristol Myers Squibb, Princeton, NJ (S.S., M.A., M.H., S.K., K.L.S., A.M.S., B.L.); the Dana-Farber Cancer Institute, Boston (F.S.H.); and Melanoma Institute Australia, University of Sydney, Royal North Shore and Mater Hospitals, Sydney (G.V.L.).
Juliana Janoski De MenezesFrom the Department of Melanoma Medical Oncology, Division of Cancer Medicine, University of Texas M.D. Anderson Cancer Center, Houston (H.A.T.); the Department of Dermatology, University Hospital Essen, and the German Cancer Consortium, Essen, Germany (D.S.); the Sidney Kimmel Comprehensive Cancer Center, Bloomberg-Kimmel Institute for Cancer Immunotherapy, Johns Hopkins University School of Medicine, Baltimore (E.J.L.); Istituto Nazionale Tumori IRCCS Fondazione "G. Pascale," Naples, Italy (P.A.A.); the Department of Oncology, Instituto Oncologico Fundacion Arturo Lopez Perez, Santiago, Chile (L.M.); FAICIC Clinical Research, Veracruz, Mexico (E.C.G.); Maria Sklodowska-Curie National Research Institute of Oncology, Warsaw, Poland (P.R.); the Department of Medicine, National and Kapodistrian University of Athens, Athens (H.J.G.); Michigan Medicine, Rogel Cancer Center, University of Michigan, Ann Arbor (C.D.L.); Hospital Nossa Senhora da Conceição, Porto Alegre, Brazil (J.J.D.M.); the Unit of Dermatology, Hospices Civils de Lyon, Cancer Research Center of Lyon, Pierre-Bénite (S.D.), and Aix-Marseille University, CHU Timone, Marseille (J.-J.G.) - both in France; the Department of Medical Oncology, Hospital Clinic Barcelona and IDIBAPS, Barcelona (A.A.); Bristol Myers Squibb, Princeton, NJ (S.S., M.A., M.H., S.K., K.L.S., A.M.S., B.L.); the Dana-Farber Cancer Institute, Boston (F.S.H.); and Melanoma Institute Australia, University of Sydney, Royal North Shore and Mater Hospitals, Sydney (G.V.L.).
Stéphane DalleFrom the Department of Melanoma Medical Oncology, Division of Cancer Medicine, University of Texas M.D. Anderson Cancer Center, Houston (H.A.T.); the Department of Dermatology, University Hospital Essen, and the German Cancer Consortium, Essen, Germany (D.S.); the Sidney Kimmel Comprehensive Cancer Center, Bloomberg-Kimmel Institute for Cancer Immunotherapy, Johns Hopkins University School of Medicine, Baltimore (E.J.L.); Istituto Nazionale Tumori IRCCS Fondazione "G. Pascale," Naples, Italy (P.A.A.); the Department of Oncology, Instituto Oncologico Fundacion Arturo Lopez Perez, Santiago, Chile (L.M.); FAICIC Clinical Research, Veracruz, Mexico (E.C.G.); Maria Sklodowska-Curie National Research Institute of Oncology, Warsaw, Poland (P.R.); the Department of Medicine, National and Kapodistrian University of Athens, Athens (H.J.G.); Michigan Medicine, Rogel Cancer Center, University of Michigan, Ann Arbor (C.D.L.); Hospital Nossa Senhora da Conceição, Porto Alegre, Brazil (J.J.D.M.); the Unit of Dermatology, Hospices Civils de Lyon, Cancer Research Center of Lyon, Pierre-Bénite (S.D.), and Aix-Marseille University, CHU Timone, Marseille (J.-J.G.) - both in France; the Department of Medical Oncology, Hospital Clinic Barcelona and IDIBAPS, Barcelona (A.A.); Bristol Myers Squibb, Princeton, NJ (S.S., M.A., M.H., S.K., K.L.S., A.M.S., B.L.); the Dana-Farber Cancer Institute, Boston (F.S.H.); and Melanoma Institute Australia, University of Sydney, Royal North Shore and Mater Hospitals, Sydney (G.V.L.).
Ana AranceFrom the Department of Melanoma Medical Oncology, Division of Cancer Medicine, University of Texas M.D. Anderson Cancer Center, Houston (H.A.T.); the Department of Dermatology, University Hospital Essen, and the German Cancer Consortium, Essen, Germany (D.S.); the Sidney Kimmel Comprehensive Cancer Center, Bloomberg-Kimmel Institute for Cancer Immunotherapy, Johns Hopkins University School of Medicine, Baltimore (E.J.L.); Istituto Nazionale Tumori IRCCS Fondazione "G. Pascale," Naples, Italy (P.A.A.); the Department of Oncology, Instituto Oncologico Fundacion Arturo Lopez Perez, Santiago, Chile (L.M.); FAICIC Clinical Research, Veracruz, Mexico (E.C.G.); Maria Sklodowska-Curie National Research Institute of Oncology, Warsaw, Poland (P.R.); the Department of Medicine, National and Kapodistrian University of Athens, Athens (H.J.G.); Michigan Medicine, Rogel Cancer Center, University of Michigan, Ann Arbor (C.D.L.); Hospital Nossa Senhora da Conceição, Porto Alegre, Brazil (J.J.D.M.); the Unit of Dermatology, Hospices Civils de Lyon, Cancer Research Center of Lyon, Pierre-Bénite (S.D.), and Aix-Marseille University, CHU Timone, Marseille (J.-J.G.) - both in France; the Department of Medical Oncology, Hospital Clinic Barcelona and IDIBAPS, Barcelona (A.A.); Bristol Myers Squibb, Princeton, NJ (S.S., M.A., M.H., S.K., K.L.S., A.M.S., B.L.); the Dana-Farber Cancer Institute, Boston (F.S.H.); and Melanoma Institute Australia, University of Sydney, Royal North Shore and Mater Hospitals, Sydney (G.V.L.).
Jean-Jacques GrobFrom the Department of Melanoma Medical Oncology, Division of Cancer Medicine, University of Texas M.D. Anderson Cancer Center, Houston (H.A.T.); the Department of Dermatology, University Hospital Essen, and the German Cancer Consortium, Essen, Germany (D.S.); the Sidney Kimmel Comprehensive Cancer Center, Bloomberg-Kimmel Institute for Cancer Immunotherapy, Johns Hopkins University School of Medicine, Baltimore (E.J.L.); Istituto Nazionale Tumori IRCCS Fondazione "G. Pascale," Naples, Italy (P.A.A.); the Department of Oncology, Instituto Oncologico Fundacion Arturo Lopez Perez, Santiago, Chile (L.M.); FAICIC Clinical Research, Veracruz, Mexico (E.C.G.); Maria Sklodowska-Curie National Research Institute of Oncology, Warsaw, Poland (P.R.); the Department of Medicine, National and Kapodistrian University of Athens, Athens (H.J.G.); Michigan Medicine, Rogel Cancer Center, University of Michigan, Ann Arbor (C.D.L.); Hospital Nossa Senhora da Conceição, Porto Alegre, Brazil (J.J.D.M.); the Unit of Dermatology, Hospices Civils de Lyon, Cancer Research Center of Lyon, Pierre-Bénite (S.D.), and Aix-Marseille University, CHU Timone, Marseille (J.-J.G.) - both in France; the Department of Medical Oncology, Hospital Clinic Barcelona and IDIBAPS, Barcelona (A.A.); Bristol Myers Squibb, Princeton, NJ (S.S., M.A., M.H., S.K., K.L.S., A.M.S., B.L.); the Dana-Farber Cancer Institute, Boston (F.S.H.); and Melanoma Institute Australia, University of Sydney, Royal North Shore and Mater Hospitals, Sydney (G.V.L.).
Shivani SrivastavaFrom the Department of Melanoma Medical Oncology, Division of Cancer Medicine, University of Texas M.D. Anderson Cancer Center, Houston (H.A.T.); the Department of Dermatology, University Hospital Essen, and the German Cancer Consortium, Essen, Germany (D.S.); the Sidney Kimmel Comprehensive Cancer Center, Bloomberg-Kimmel Institute for Cancer Immunotherapy, Johns Hopkins University School of Medicine, Baltimore (E.J.L.); Istituto Nazionale Tumori IRCCS Fondazione "G. Pascale," Naples, Italy (P.A.A.); the Department of Oncology, Instituto Oncologico Fundacion Arturo Lopez Perez, Santiago, Chile (L.M.); FAICIC Clinical Research, Veracruz, Mexico (E.C.G.); Maria Sklodowska-Curie National Research Institute of Oncology, Warsaw, Poland (P.R.); the Department of Medicine, National and Kapodistrian University of Athens, Athens (H.J.G.); Michigan Medicine, Rogel Cancer Center, University of Michigan, Ann Arbor (C.D.L.); Hospital Nossa Senhora da Conceição, Porto Alegre, Brazil (J.J.D.M.); the Unit of Dermatology, Hospices Civils de Lyon, Cancer Research Center of Lyon, Pierre-Bénite (S.D.), and Aix-Marseille University, CHU Timone, Marseille (J.-J.G.) - both in France; the Department of Medical Oncology, Hospital Clinic Barcelona and IDIBAPS, Barcelona (A.A.); Bristol Myers Squibb, Princeton, NJ (S.S., M.A., M.H., S.K., K.L.S., A.M.S., B.L.); the Dana-Farber Cancer Institute, Boston (F.S.H.); and Melanoma Institute Australia, University of Sydney, Royal North Shore and Mater Hospitals, Sydney (G.V.L.).
Mena AbaskharounFrom the Department of Melanoma Medical Oncology, Division of Cancer Medicine, University of Texas M.D. Anderson Cancer Center, Houston (H.A.T.); the Department of Dermatology, University Hospital Essen, and the German Cancer Consortium, Essen, Germany (D.S.); the Sidney Kimmel Comprehensive Cancer Center, Bloomberg-Kimmel Institute for Cancer Immunotherapy, Johns Hopkins University School of Medicine, Baltimore (E.J.L.); Istituto Nazionale Tumori IRCCS Fondazione "G. Pascale," Naples, Italy (P.A.A.); the Department of Oncology, Instituto Oncologico Fundacion Arturo Lopez Perez, Santiago, Chile (L.M.); FAICIC Clinical Research, Veracruz, Mexico (E.C.G.); Maria Sklodowska-Curie National Research Institute of Oncology, Warsaw, Poland (P.R.); the Department of Medicine, National and Kapodistrian University of Athens, Athens (H.J.G.); Michigan Medicine, Rogel Cancer Center, University of Michigan, Ann Arbor (C.D.L.); Hospital Nossa Senhora da Conceição, Porto Alegre, Brazil (J.J.D.M.); the Unit of Dermatology, Hospices Civils de Lyon, Cancer Research Center of Lyon, Pierre-Bénite (S.D.), and Aix-Marseille University, CHU Timone, Marseille (J.-J.G.) - both in France; the Department of Medical Oncology, Hospital Clinic Barcelona and IDIBAPS, Barcelona (A.A.); Bristol Myers Squibb, Princeton, NJ (S.S., M.A., M.H., S.K., K.L.S., A.M.S., B.L.); the Dana-Farber Cancer Institute, Boston (F.S.H.); and Melanoma Institute Australia, University of Sydney, Royal North Shore and Mater Hospitals, Sydney (G.V.L.).
Melissa HamiltonFrom the Department of Melanoma Medical Oncology, Division of Cancer Medicine, University of Texas M.D. Anderson Cancer Center, Houston (H.A.T.); the Department of Dermatology, University Hospital Essen, and the German Cancer Consortium, Essen, Germany (D.S.); the Sidney Kimmel Comprehensive Cancer Center, Bloomberg-Kimmel Institute for Cancer Immunotherapy, Johns Hopkins University School of Medicine, Baltimore (E.J.L.); Istituto Nazionale Tumori IRCCS Fondazione "G. Pascale," Naples, Italy (P.A.A.); the Department of Oncology, Instituto Oncologico Fundacion Arturo Lopez Perez, Santiago, Chile (L.M.); FAICIC Clinical Research, Veracruz, Mexico (E.C.G.); Maria Sklodowska-Curie National Research Institute of Oncology, Warsaw, Poland (P.R.); the Department of Medicine, National and Kapodistrian University of Athens, Athens (H.J.G.); Michigan Medicine, Rogel Cancer Center, University of Michigan, Ann Arbor (C.D.L.); Hospital Nossa Senhora da Conceição, Porto Alegre, Brazil (J.J.D.M.); the Unit of Dermatology, Hospices Civils de Lyon, Cancer Research Center of Lyon, Pierre-Bénite (S.D.), and Aix-Marseille University, CHU Timone, Marseille (J.-J.G.) - both in France; the Department of Medical Oncology, Hospital Clinic Barcelona and IDIBAPS, Barcelona (A.A.); Bristol Myers Squibb, Princeton, NJ (S.S., M.A., M.H., S.K., K.L.S., A.M.S., B.L.); the Dana-Farber Cancer Institute, Boston (F.S.H.); and Melanoma Institute Australia, University of Sydney, Royal North Shore and Mater Hospitals, Sydney (G.V.L.).
Sarah KeidelFrom the Department of Melanoma Medical Oncology, Division of Cancer Medicine, University of Texas M.D. Anderson Cancer Center, Houston (H.A.T.); the Department of Dermatology, University Hospital Essen, and the German Cancer Consortium, Essen, Germany (D.S.); the Sidney Kimmel Comprehensive Cancer Center, Bloomberg-Kimmel Institute for Cancer Immunotherapy, Johns Hopkins University School of Medicine, Baltimore (E.J.L.); Istituto Nazionale Tumori IRCCS Fondazione "G. Pascale," Naples, Italy (P.A.A.); the Department of Oncology, Instituto Oncologico Fundacion Arturo Lopez Perez, Santiago, Chile (L.M.); FAICIC Clinical Research, Veracruz, Mexico (E.C.G.); Maria Sklodowska-Curie National Research Institute of Oncology, Warsaw, Poland (P.R.); the Department of Medicine, National and Kapodistrian University of Athens, Athens (H.J.G.); Michigan Medicine, Rogel Cancer Center, University of Michigan, Ann Arbor (C.D.L.); Hospital Nossa Senhora da Conceição, Porto Alegre, Brazil (J.J.D.M.); the Unit of Dermatology, Hospices Civils de Lyon, Cancer Research Center of Lyon, Pierre-Bénite (S.D.), and Aix-Marseille University, CHU Timone, Marseille (J.-J.G.) - both in France; the Department of Medical Oncology, Hospital Clinic Barcelona and IDIBAPS, Barcelona (A.A.); Bristol Myers Squibb, Princeton, NJ (S.S., M.A., M.H., S.K., K.L.S., A.M.S., B.L.); the Dana-Farber Cancer Institute, Boston (F.S.H.); and Melanoma Institute Australia, University of Sydney, Royal North Shore and Mater Hospitals, Sydney (G.V.L.).
Katy L SimonsenFrom the Department of Melanoma Medical Oncology, Division of Cancer Medicine, University of Texas M.D. Anderson Cancer Center, Houston (H.A.T.); the Department of Dermatology, University Hospital Essen, and the German Cancer Consortium, Essen, Germany (D.S.); the Sidney Kimmel Comprehensive Cancer Center, Bloomberg-Kimmel Institute for Cancer Immunotherapy, Johns Hopkins University School of Medicine, Baltimore (E.J.L.); Istituto Nazionale Tumori IRCCS Fondazione "G. Pascale," Naples, Italy (P.A.A.); the Department of Oncology, Instituto Oncologico Fundacion Arturo Lopez Perez, Santiago, Chile (L.M.); FAICIC Clinical Research, Veracruz, Mexico (E.C.G.); Maria Sklodowska-Curie National Research Institute of Oncology, Warsaw, Poland (P.R.); the Department of Medicine, National and Kapodistrian University of Athens, Athens (H.J.G.); Michigan Medicine, Rogel Cancer Center, University of Michigan, Ann Arbor (C.D.L.); Hospital Nossa Senhora da Conceição, Porto Alegre, Brazil (J.J.D.M.); the Unit of Dermatology, Hospices Civils de Lyon, Cancer Research Center of Lyon, Pierre-Bénite (S.D.), and Aix-Marseille University, CHU Timone, Marseille (J.-J.G.) - both in France; the Department of Medical Oncology, Hospital Clinic Barcelona and IDIBAPS, Barcelona (A.A.); Bristol Myers Squibb, Princeton, NJ (S.S., M.A., M.H., S.K., K.L.S., A.M.S., B.L.); the Dana-Farber Cancer Institute, Boston (F.S.H.); and Melanoma Institute Australia, University of Sydney, Royal North Shore and Mater Hospitals, Sydney (G.V.L.).
Anne Marie SobieskFrom the Department of Melanoma Medical Oncology, Division of Cancer Medicine, University of Texas M.D. Anderson Cancer Center, Houston (H.A.T.); the Department of Dermatology, University Hospital Essen, and the German Cancer Consortium, Essen, Germany (D.S.); the Sidney Kimmel Comprehensive Cancer Center, Bloomberg-Kimmel Institute for Cancer Immunotherapy, Johns Hopkins University School of Medicine, Baltimore (E.J.L.); Istituto Nazionale Tumori IRCCS Fondazione "G. Pascale," Naples, Italy (P.A.A.); the Department of Oncology, Instituto Oncologico Fundacion Arturo Lopez Perez, Santiago, Chile (L.M.); FAICIC Clinical Research, Veracruz, Mexico (E.C.G.); Maria Sklodowska-Curie National Research Institute of Oncology, Warsaw, Poland (P.R.); the Department of Medicine, National and Kapodistrian University of Athens, Athens (H.J.G.); Michigan Medicine, Rogel Cancer Center, University of Michigan, Ann Arbor (C.D.L.); Hospital Nossa Senhora da Conceição, Porto Alegre, Brazil (J.J.D.M.); the Unit of Dermatology, Hospices Civils de Lyon, Cancer Research Center of Lyon, Pierre-Bénite (S.D.), and Aix-Marseille University, CHU Timone, Marseille (J.-J.G.) - both in France; the Department of Medical Oncology, Hospital Clinic Barcelona and IDIBAPS, Barcelona (A.A.); Bristol Myers Squibb, Princeton, NJ (S.S., M.A., M.H., S.K., K.L.S., A.M.S., B.L.); the Dana-Farber Cancer Institute, Boston (F.S.H.); and Melanoma Institute Australia, University of Sydney, Royal North Shore and Mater Hospitals, Sydney (G.V.L.).
Bin LiFrom the Department of Melanoma Medical Oncology, Division of Cancer Medicine, University of Texas M.D. Anderson Cancer Center, Houston (H.A.T.); the Department of Dermatology, University Hospital Essen, and the German Cancer Consortium, Essen, Germany (D.S.); the Sidney Kimmel Comprehensive Cancer Center, Bloomberg-Kimmel Institute for Cancer Immunotherapy, Johns Hopkins University School of Medicine, Baltimore (E.J.L.); Istituto Nazionale Tumori IRCCS Fondazione "G. Pascale," Naples, Italy (P.A.A.); the Department of Oncology, Instituto Oncologico Fundacion Arturo Lopez Perez, Santiago, Chile (L.M.); FAICIC Clinical Research, Veracruz, Mexico (E.C.G.); Maria Sklodowska-Curie National Research Institute of Oncology, Warsaw, Poland (P.R.); the Department of Medicine, National and Kapodistrian University of Athens, Athens (H.J.G.); Michigan Medicine, Rogel Cancer Center, University of Michigan, Ann Arbor (C.D.L.); Hospital Nossa Senhora da Conceição, Porto Alegre, Brazil (J.J.D.M.); the Unit of Dermatology, Hospices Civils de Lyon, Cancer Research Center of Lyon, Pierre-Bénite (S.D.), and Aix-Marseille University, CHU Timone, Marseille (J.-J.G.) - both in France; the Department of Medical Oncology, Hospital Clinic Barcelona and IDIBAPS, Barcelona (A.A.); Bristol Myers Squibb, Princeton, NJ (S.S., M.A., M.H., S.K., K.L.S., A.M.S., B.L.); the Dana-Farber Cancer Institute, Boston (F.S.H.); and Melanoma Institute Australia, University of Sydney, Royal North Shore and Mater Hospitals, Sydney (G.V.L.).
F Stephen HodiFrom the Department of Melanoma Medical Oncology, Division of Cancer Medicine, University of Texas M.D. Anderson Cancer Center, Houston (H.A.T.); the Department of Dermatology, University Hospital Essen, and the German Cancer Consortium, Essen, Germany (D.S.); the Sidney Kimmel Comprehensive Cancer Center, Bloomberg-Kimmel Institute for Cancer Immunotherapy, Johns Hopkins University School of Medicine, Baltimore (E.J.L.); Istituto Nazionale Tumori IRCCS Fondazione "G. Pascale," Naples, Italy (P.A.A.); the Department of Oncology, Instituto Oncologico Fundacion Arturo Lopez Perez, Santiago, Chile (L.M.); FAICIC Clinical Research, Veracruz, Mexico (E.C.G.); Maria Sklodowska-Curie National Research Institute of Oncology, Warsaw, Poland (P.R.); the Department of Medicine, National and Kapodistrian University of Athens, Athens (H.J.G.); Michigan Medicine, Rogel Cancer Center, University of Michigan, Ann Arbor (C.D.L.); Hospital Nossa Senhora da Conceição, Porto Alegre, Brazil (J.J.D.M.); the Unit of Dermatology, Hospices Civils de Lyon, Cancer Research Center of Lyon, Pierre-Bénite (S.D.), and Aix-Marseille University, CHU Timone, Marseille (J.-J.G.) - both in France; the Department of Medical Oncology, Hospital Clinic Barcelona and IDIBAPS, Barcelona (A.A.); Bristol Myers Squibb, Princeton, NJ (S.S., M.A., M.H., S.K., K.L.S., A.M.S., B.L.); the Dana-Farber Cancer Institute, Boston (F.S.H.); and Melanoma Institute Australia, University of Sydney, Royal North Shore and Mater Hospitals, Sydney (G.V.L.).
Georgina V LongFrom the Department of Melanoma Medical Oncology, Division of Cancer Medicine, University of Texas M.D. Anderson Cancer Center, Houston (H.A.T.); the Department of Dermatology, University Hospital Essen, and the German Cancer Consortium, Essen, Germany (D.S.); the Sidney Kimmel Comprehensive Cancer Center, Bloomberg-Kimmel Institute for Cancer Immunotherapy, Johns Hopkins University School of Medicine, Baltimore (E.J.L.); Istituto Nazionale Tumori IRCCS Fondazione "G. Pascale," Naples, Italy (P.A.A.); the Department of Oncology, Instituto Oncologico Fundacion Arturo Lopez Perez, Santiago, Chile (L.M.); FAICIC Clinical Research, Veracruz, Mexico (E.C.G.); Maria Sklodowska-Curie National Research Institute of Oncology, Warsaw, Poland (P.R.); the Department of Medicine, National and Kapodistrian University of Athens, Athens (H.J.G.); Michigan Medicine, Rogel Cancer Center, University of Michigan, Ann Arbor (C.D.L.); Hospital Nossa Senhora da Conceição, Porto Alegre, Brazil (J.J.D.M.); the Unit of Dermatology, Hospices Civils de Lyon, Cancer Research Center of Lyon, Pierre-Bénite (S.D.), and Aix-Marseille University, CHU Timone, Marseille (J.-J.G.) - both in France; the Department of Medical Oncology, Hospital Clinic Barcelona and IDIBAPS, Barcelona (A.A.); Bristol Myers Squibb, Princeton, NJ (S.S., M.A., M.H., S.K., K.L.S., A.M.S., B.L.); the Dana-Farber Cancer Institute, Boston (F.S.H.); and Melanoma Institute Australia, University of Sydney, Royal North Shore and Mater Hospitals, Sydney (G.V.L.).ORCID 0000-0001-8894-3545
RELATIVITY-047 Investigators
Johns Hopkins University · US

Funding

Tumor Evolution and Metastasis ProgramP30CA016672 · NCI · UNIVERSITY OF TX MD ANDERSON CAN CTR · PI Kathrin Milbury · 1985 to 2026
$290.8M
Translational Research Central ServicesP30CA006973 · NCI · JOHNS HOPKINS UNIVERSITY · PI Rosalie Wollett · 1985 to 2026
$208.6M
NCI NIH HHS P30 CA006973NCI NIH HHS P30 CA016672
6 · The paper itself

Abstract

backgroundLymphocyte-activation gene 3 (LAG-3) and programmed death 1 (PD-1) are distinct inhibitory immune checkpoints that contribute to T-cell exhaustion. The combination of relatlimab, a LAG-3-blocking antibody, and nivolumab, a PD-1-blocking antibody, has been shown to be safe and to have antitumor activity in patients with previously treated melanoma, but the safety and activity in patients with previously untreated melanoma need investigation.

methodsIn this phase 2-3, global, double-blind, randomized trial, we evaluated relatlimab and nivolumab as a fixed-dose combination as compared with nivolumab alone when administered intravenously every 4 weeks to patients with previously untreated metastatic or unresectable melanoma. The primary end point was progression-free survival as assessed by blinded independent central review.

resultsThe median progression-free survival was 10.1 months (95% confidence interval [CI], 6.4 to 15.7) with relatlimab-nivolumab as compared with 4.6 months (95% CI, 3.4 to 5.6) with nivolumab (hazard ratio for progression or death, 0.75 [95% CI, 0.62 to 0.92]; P = 0.006 by the log-rank test). Progression-free survival at 12 months was 47.7% (95% CI, 41.8 to 53.2) with relatlimab-nivolumab as compared with 36.0% (95% CI, 30.5 to 41.6) with nivolumab. Progression-free survival across key subgroups favored relatlimab-nivolumab over nivolumab. Grade 3 or 4 treatment-related adverse events occurred in 18.9% of patients in the relatlimab-nivolumab group and in 9.7% of patients in the nivolumab group.

conclusionsThe inhibition of two immune checkpoints, LAG-3 and PD-1, provided a greater benefit with regard to progression-free survival than inhibition of PD-1 alone in patients with previously untreated metastatic or unresectable melanoma. Relatlimab and nivolumab in combination showed no new safety signals. (Funded by Bristol Myers Squibb; RELATIVITY-047 ClinicalTrials.gov number, NCT03470922.).

Indexed as

AdultAgedAged, 80 and overAntibodies, Monoclonal, HumanizedAntigens, CDAntineoplastic Combined Chemotherapy ProtocolsB7-H1 AntigenDouble-Blind MethodFemaleHumansImmune Checkpoint InhibitorsLymphocyte Activation Gene 3 ProteinMaleMelanomaMiddle AgedNivolumabAntibodies, Monoclonal, HumanizedAntigens, CDB7-H1 AntigenCD274 protein, humanImmune Checkpoint InhibitorsLag3 protein, humanLymphocyte Activation Gene 3 ProteinNivolumabrelatlimab

Identifiers

PMID34986285
PMCPMC9844513
OpenAlexW4206239577

What Socratic holds

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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 Socratic graph.