Evidence map›Paper›PMID 37845511›Full record

Trial reportNature medicine2023

Adjuvant nivolumab in resected stage IIB/C melanoma: primary results from the randomized, phase 3 CheckMate 76K trial.

John M Kirkwood, Michele Del Vecchio, Jeffrey Weber, Christoph Hoeller, Jean-Jacques Grob, Peter Mohr, Carmen Loquai, Caroline Dutriaux, Vanna Chiarion-Sileni, Jacek Mackiewicz and 11 more

Erratum issued 2 registry-linked trialsOpen access · hybridAbstract readClinical Trial, Phase IIIRandomized Controlled Trial
In one paragraph

Trial report in Nature medicine, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. An erratum has been issued. It is linked to 2 registered trials, which are not on this map. Cited by 116 papers, 9 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
116citing papers in PubMed, 9 pooled it
41.4field-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.

NCT04099251 phase3active not recruitingnot on this map

A Phase 3, Randomized, Double-Blind Study of Adjuvant Immunotherapy With Nivolumab Versus Placebo After Complete Resection of Stage IIB/C Melanoma

TypeinterventionalSponsorBristol-Myers SquibbRan2019 to 2026Enrolled790ConditionsMelanomaArmsNivolumab, Placebo
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

116 citing papers in PubMed, 9 syntheses or guidelines pooled it, 180 citations in OpenAlex.

  1. Pooled it
  2. Cancer-related fatigue during treatment with neoadjuvant and/or adjuvant immune checkpoint inhibitors: a systematic review and meta-analysis.Supportive care in cancer : official journal of the Multinational Association of Supportive Care in Cancer · 2026
    Pooled it
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  9. SEOM-GEM clinical guidelines for cutaneous melanoma (2023).Clinical & translational oncology : official publication of the Federation of Spanish Oncology Societies and of the National Cancer Institute of Mexico · 2024
    Guideline
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56 more citing papers are in PubMed but not listed here.

4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

21 authors at 18 institutions in 8 countries.

John M KirkwoodUPMC Hillman Cancer Center, Pittsburgh, PA, USA. kirkwoodjm@upmc.edu.ORCID 0000-0002-3570-4476
Michele Del VecchioFondazione IRCCS Istituto Nazionale dei Tumori, Milan, Italy.
Jeffrey WeberNYU Langone Medical Center, New York, NY, USA.
Christoph HoellerMedizinische Universität Wien, Vienna, Austria.ORCID 0000-0003-1192-0227
Jean-Jacques GrobHôpital de la Timone, Marseille, France.
Peter MohrElbe Klinikum Buxtehude, Buxtehude, Germany.
Carmen LoquaiUniversity Medical Center Mainz, Mainz, Germany.
Caroline DutriauxHôpital Saint André, Bordeaux, France.
Vanna Chiarion-SileniIstituto Oncologico Veneto, IOV-IRCCS, Padova, Italy.
Jacek MackiewiczInstitute of Oncology, Poznan University of Medical Sciences, Poznan, Poland.
Piotr RutkowskiMaria Skłodowska-Curie National Research Institute of Oncology, Warsaw, Poland.
Petr ArenbergerCharles University Third Faculty of Medicine and University Hospital Královské Vinohrady, Prague, Czech Republic.
Gaelle QuereuxNantes University Hospital, Nantes, France.
Tarek M MeniawyUniversity of Western Australia and Sir Charles Gairdner Hospital, Perth, WA, Australia.ORCID 0000-0002-1457-6137
Paolo A AsciertoIstituto Nazionale Tumori IRCCS 'Fondazione G. Pascale', Naples, Italy.ORCID 0000-0002-8322-475X
Alexander M MenziesMelanoma Institute Australia, University of Sydney, and Royal North Shore and Mater Hospitals, Sydney, NSW, Australia.
Piyush DuraniBristol Myers Squibb, Princeton, NJ, USA.
Maurice LoboBristol Myers Squibb, Princeton, NJ, USA.
Federico CampigottoBristol Myers Squibb, Princeton, NJ, USA.
Brian Gastman *Cleveland Clinic, Cleveland, OH, USA.
Georgina V Long *Melanoma Institute Australia, University of Sydney, and Royal North Shore and Mater Hospitals, Sydney, NSW, Australia.ORCID 0000-0001-8894-3545
Bristol-Myers Squibb (United States) · USThe University of Sydney · AUCharles University · CZCleveland Clinic · USElbe Kliniken Stade-Buxtehude · DEFondazione IRCCS Istituto Nazionale dei Tumori · ITHôpital de la Timone · FRHôpital Saint-André · FRIstituto Nazionale Tumori IRCCS "Fondazione G. Pascale" · ITIstituto Oncologico Veneto · ITJohannes Gutenberg University Mainz · DEMedical University of Vienna · ATNantes Université · FRNYU Langone Health · USPoznan University of Medical Sciences · PLThe Maria Sklodowska-Curie National Research Institute of Oncology · PLThe University of Western Australia · AUUPMC Health System · US

Funding

Project 4P50CA225450 · NCI · NEW YORK UNIVERSITY SCHOOL OF MEDICINE · PI OSMAN, IMAN, WEBER, JEFFREY S · 2019 to 2025
$12.5M
NCI NIH HHS P50 CA225450
6 · The paper itself

Abstract

Patients with resected stage IIB/C melanoma have high recurrence risk, similar to those with resected stage IIIA/B disease. The phase 3, double-blind CheckMate 76K trial assessed 790 patients with resected stage IIB/C melanoma randomized 2:1 (stratified by tumor category) to nivolumab 480 mg or placebo every 4 weeks for 12 months. The primary endpoint was investigator-assessed recurrence-free survival (RFS). Secondary endpoints included distant metastasis-free survival (DMFS) and safety. At 7.8 months of minimum follow-up, nivolumab significantly improved RFS versus placebo (hazard ratio (HR) = 0.42; 95% confidence interval (CI): 0.30-0.59; P < 0.0001), with 12-month RFS of 89.0% versus 79.4% and benefit observed across subgroups; DMFS was also improved (HR = 0.47; 95% CI: 0.30-0.72). Treatment-related grade 3/4 adverse events occurred in 10.3% (nivolumab) and 2.3% (placebo) of patients. One treatment-related death (0.2%) occurred with nivolumab. Nivolumab is an effective and generally well-tolerated adjuvant treatment in patients with resected stage IIB/C melanoma. ClinicalTrials.gov identifier: NCT04099251 .

Indexed as

MelanomaSkin NeoplasmsAdjuvants, ImmunologicAntineoplastic Combined Chemotherapy ProtocolsCutaneous Malignant MelanomaDouble-Blind MethodHumansNeoplasm StagingNivolumabAdjuvants, ImmunologicNivolumab

Identifiers

PMID37845511
PMCPMC10667090
OpenAlexW4387666867

What OpenQuestion 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 OpenQuestion graph.