Evidence map›Paper›PMID 34818112›Full record

Trial reportJournal of clinical oncology : official journal of the American Society of Clinical Oncology2022

Long-Term Outcomes With Nivolumab Plus Ipilimumab or Nivolumab Alone Versus Ipilimumab in Patients With Advanced Melanoma.

Jedd D Wolchok, Vanna Chiarion-Sileni, Rene Gonzalez, Jean-Jacques Grob, Piotr Rutkowski, Christopher D Lao, C Lance Cowey, Dirk Schadendorf, John Wagstaff, Reinhard Dummer and 19 more

Open access · hybridAbstract readClinical Trial, Phase IIIComparative StudyMulticenter Study
In one paragraph

Trial report in Journal of clinical oncology : official journal of the American Society of Clinical Oncology, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 692 papers, 7 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
692citing papers in PubMed, 7 pooled it
67.0field-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.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

692 citing papers in PubMed, 7 syntheses or guidelines pooled it, 1,072 citations in OpenAlex.

  1. Pooled it
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  6. Survival after cessation of immunotherapies in melanoma: A systematic review and meta-analysis.Journal of the European Academy of Dermatology and Venereology : JEADV · 2025
    Pooled it
  7. Pooled it
  8. Trial
  9. RP1 Combined With Nivolumab in Advanced Anti-PD-1-Failed Melanoma (IGNYTE).Journal of clinical oncology : official journal of the American Society of Clinical Oncology · 2025
    Trial
  10. Dual Immune Check Point Blockade inJournal of clinical oncology : official journal of the American Society of Clinical Oncology · 2025
    Trial
  11. Trial
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  13. Trial
  14. Neoadjuvant Nivolumab Plus Ipilimumab Versus Chemotherapy in Resectable Lung Cancer.Journal of clinical oncology : official journal of the American Society of Clinical Oncology · 2025
    Trial
  15. Trial
  16. Article
  17. Article
  18. Review
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  20. Review

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

4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

29 authors at 20 institutions in 12 countries.

Jedd D WolchokMemorial Sloan Kettering Cancer Center and Weill Cornell Medical College, New York, NY.ORCID 0000-0001-6718-2222
Vanna Chiarion-SileniVenteo Institute of Oncology IOV-IRCCS, Padua, Italy.ORCID 0000-0001-9191-9124
Rene GonzalezUniversity of Colorado Cancer Center, Aurora, CO.
Jean-Jacques GrobAix-Marseille University, APHM Timone France, Marseille, France.ORCID 0000-0002-0667-153X
Piotr RutkowskiMaria Sklodowska-Curie National Institute of Oncology Center, Warsaw, Poland.ORCID 0000-0002-8920-5429
Christopher D LaoUniversity of Michigan, Ann Arbor, MI.
C Lance CoweyTexas Oncology-Baylor Charles A. Sammons Cancer Center, Dallas, TX.
Dirk SchadendorfUniversity of Essen, Essen, and German Cancer Consortium, Heidelberg, Germany.ORCID 0000-0003-3524-7858
John WagstaffThe College of Medicine, Swansea University, Swansea, United Kingdom.ORCID 0000-0002-1140-5981
Reinhard DummerUniversitäts Spital Zürich, Zürich, Switzerland.ORCID 0000-0002-2279-6906
Pier Francesco FerrucciEuropean Institute of Oncology IRCCS, Milan, Italy.ORCID 0000-0001-6255-5851
Michael SmylieCross Cancer Institute, Edmonton, Alberta, Canada.
Marcus O ButlerPrincess Margaret Cancer Centre, Toronto, Ontario, Canada.ORCID 0000-0002-9840-7057
Andrew HillTasman Oncology Research, Southport, Queensland, Australia.
Ivan Márquez-RodasHospital General Universitario Gregorio Marañon, Madrid, Spain.ORCID 0000-0002-2476-668X
John B A G HaanenNetherlands Cancer Institute, Amsterdam, the Netherlands.ORCID 0000-0001-5884-7704
Massimo GuidoboniIstituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori IRCCS, Meldola, Italy.
Michele MaioCenter for Immuno-Oncology, University Hospital of Siena, Siena, Italy.ORCID 0000-0002-0323-6321
Patrick SchöffskiUniversity Hospitals Leuven, Department of General Medical Oncology, Leuven Cancer Institute, KU Leuven, Leuven, Belgium.ORCID 0000-0001-5980-030X
Matteo S CarlinoWestmead and Blacktown Hospitals, University of Sydney, Melanoma Institute Australia, Sydney, Australia.
Céleste LebbéUniversité de Paris, Department of Dermatology and CIC, AP-HP Hôpital Saint Louis, INSERM U976, Paris, France.ORCID 0000-0002-5854-7290
Grant McArthurPeter MacCallum Cancer Centre, East Melbourne, Australia.ORCID 0000-0001-8908-6071
Paolo A AsciertoMelanoma Cancer Immunotherapy and Innovative Therapy Unit, Istituto Nazionale Tumori IRCCS Fondazione Pascale, Napoli, Italy.ORCID 0000-0002-8322-475X
Gregory A DanielsUC San Diego Health - La Jolla, La Jolla, CA.ORCID 0000-0001-9087-8009
Georgina V LongMelanoma Institute Australia, The University of Sydney, and Royal North Shore and Mater Hospitals, Sydney, Australia.ORCID 0000-0001-8894-3545
Tuba BasBristol Myers Squibb, Princeton, NJ.
Corey RitchingsBristol Myers Squibb, Princeton, NJ.ORCID 0000-0002-9240-9211
James LarkinThe Royal Marsden Hospital NHS Foundation Trust, London, United Kingdom.ORCID 0000-0001-5569-9523
F Stephen HodiDana-Farber Cancer Institute, Boston, MA.ORCID 0000-0001-6825-091X
Bristol-Myers Squibb (United States) · USThe University of Sydney · AUAix-Marseille Université · FRAlberta Cancer Foundation · CADana-Farber Cancer Institute · USEuropean Institute of Oncology · ITGerman Cancer Research Center · DEHospital General Universitario Gregorio Marañón · ESInserm · FRIstituto Nazionale Tumori IRCCS "Fondazione G. Pascale" · ITIstituto Oncologico Veneto · ITIstituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori · ITKU Leuven · BEMemorial Sloan Kettering Cancer Center · USPeter MacCallum Cancer Centre · AUPrincess Margaret Cancer Centre · CARoyal Marsden Hospital · GBSee-Spital · CHSwansea University · GBTexas Oncology · US

Funding

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

Abstract

purposeIn the phase III CheckMate 067 trial, durable clinical benefit was demonstrated previously with nivolumab plus ipilimumab and nivolumab alone versus ipilimumab. Here, we report 6.5-year efficacy and safety outcomes. PATIENTS AND

methodsPatients with previously untreated unresectable stage III or stage IV melanoma were randomly assigned 1:1:1 to receive nivolumab 1 mg/kg plus ipilimumab 3 mg/kg once every 3 weeks (four doses) followed by nivolumab 3 mg/kg once every 2 weeks (n = 314), nivolumab 3 mg/kg once every 2 weeks (n = 316), or ipilimumab 3 mg/kg once every 3 weeks (four doses; n = 315). Coprimary end points were progression-free survival and overall survival (OS) with nivolumab plus ipilimumab or nivolumab versus ipilimumab. Secondary end points included objective response rate, descriptive efficacy assessments of nivolumab plus ipilimumab versus nivolumab alone, and safety. Melanoma-specific survival (MSS; descriptive analysis), which excludes deaths unrelated to melanoma, was also evaluated.

resultsMedian OS (minimum follow-up, 6.5 years) was 72.1, 36.9, and 19.9 months in the combination, nivolumab, and ipilimumab groups, respectively. Median MSS was not reached, 58.7, and 21.9 months, respectively; 6.5-year OS rates were 57%, 43%, and 25% in patients with

conclusionThese 6.5-year CheckMate 067 results, which include the longest median OS in a phase III melanoma trial reported to date and the first report of MSS, showed durable, improved clinical outcomes with nivolumab plus ipilimumab or nivolumab versus ipilimumab in patients with advanced melanoma and, in descriptive analyses, with the combination over nivolumab monotherapy.

Indexed as

Antineoplastic Combined Chemotherapy ProtocolsDisease ProgressionHumansIpilimumabMelanomaNeoplasm StagingNivolumabProgression-Free SurvivalSkin NeoplasmsTime FactorsIpilimumabNivolumab

Identifiers

PMID34818112
PMCPMC8718224
OpenAlexW3217126890

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Registered trials

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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.