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Five-Year Survival with Combined Nivolumab and Ipilimumab in Advanced Melanoma
Open accessAbstract
BACKGROUNDNivolumab plus ipilimumab or nivolumab alone resulted in longer progression-free and overall survival than ipilimumab alone in a trial involving patients with advanced melanoma.We now report 5-year outcomes in the trial. METHODSWe randomly assigned patients with previously untreated advanced melanoma to receive one of the following regimens: nivolumab (at a dose of 1 mg per kilogram of body weight) plus ipilimumab (3 mg per kilogram) every 3 weeks for four doses, followed by nivolumab (3 mg per kilogram every 2 weeks); nivolumab (3 mg per kilogram every 2 weeks) plus ipilimumab-matched placebo; or ipilimumab (3 mg per kilogram every 3 weeks for four doses) plus nivolumab-matched placebo.The two primary end points were progression-free survival and overall survival in the nivolumab-plus-ipilimumab group and in the nivolumab group, as compared with the ipilimumab group. RESULTSAt a minimum follow-up of 60 months, the median overall survival was more than 60.0 months (median not reached) in the nivolumab-plus-ipilimumab group and 36.9 months in the nivolumab group, as compared with 19.9 months in the ipilimumab group (hazard ratio for death with nivolumab plus ipilimumab vs. ipilimumab, 0.52; hazard ratio for death with nivolumab vs. ipilimumab, 0.63).Overall survival at 5 years was 52% in the nivolumab-plus-ipilimumab group and 44% in the nivolumab group, as compared with 26% in the ipilimumab group.No sustained deterioration of health-related quality of life was observed during or after treatment with nivolumab plus ipilimumab or with nivolumab alone.No new late toxic effects were noted. CONCLUSIONSAmong patients with advanced melanoma, sustained long-term overall survival at 5 years was observed in a greater percentage of patients who received nivolumab plus ipilimumab or nivolumab alone than in those who received ipilimumab alone, with no apparent loss of quality of life in the patients who received regimens containing nivolumab.(Funded by Bristol-Myers Squibb and others; CheckMate 067 ClinicalTrials.govnumber, NCT01844505.
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“In many cancers, nivolumab in combination with ipilimumab improves response rates compared to either agent alone, but the combination has not been evaluated in childhood cancer.”
From A Phase I/II Trial of Nivolumab plus Ipilimumab in Children and Young Adults with Relapsed/Refractory Solid Tumors: A Children's Oncology Group Study ADVL1412 (2022) · cites this paper as [12]
Experimental — accuracy not yet measuredThe source backs part of the claim, not all of it — or backs it for a different population, condition or comparison.
In the citing paper
“Nivolumab, a PD-1 inhibitor, in combination with ipilimumab, a CTLA-4 inhibitor, has shown favourable efficacy outcomes and manageable safety profiles across multiple tumour types.”
From Nivolumab plus ipilimumab versus lenvatinib or sorafenib as first-line treatment for unresectable hepatocellular carcinoma (CheckMate 9DW): an open-label, randomised, phase 3 trial (2025) · cites this paper as [12]
Experimental — accuracy not yet measuredThe source backs part of the claim, not all of it — or backs it for a different population, condition or comparison.
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“While immune checkpoint inhibitors (ICIs) have greatly enhanced clinical outcomes across multiple cancer types,1, 2, 3”
From irAE-GPT: leveraging large language models to identify immune-related adverse events in electronic health records and clinical trial datasets (2026) · cites this paper as [3]
Experimental — accuracy not yet measuredThe cited source says what the claim attributes to it.
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“In unresectable or metastatic melanoma, overall survival at 5 years is 52% following nivolumab plus ipilimumab compared to 44% for nivolumab alone and 26% for ipilimumab alone12,13.”
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In the citing paper
“Evidence for benefit of nivolumab plus ipilimumab compared to single agent ICI has also been demonstrated in patients with advanced renal cell cancer, microsatellite high/deficient mismatch repair (MSI-hi/dMMR) metastatic colorectal cancer12,14,15, hepatocellular carcinoma16, and non-small cell, EGFR/ALK wild type lung cancer17–19.”
From A Phase I/II Trial of Nivolumab plus Ipilimumab in Children and Young Adults with Relapsed/Refractory Solid Tumors: A Children's Oncology Group Study ADVL1412 (2022) · cites this paper as [12]
Experimental — accuracy not yet measured
In the citing paper
“Melanomas and urothelial carcinomas that are intrinsically resistant to anti-PD-1/PD-L1 therapy show elevated TGF-β signaling, particularly in the stromal compartment of immune excluded tumors21,77,228,361.”
From TGFβ biology in cancer progression and immunotherapy (2021) · cites this paper as [361]
In the citing paper
“Multiple clinical trials with combined blockade of CTLA4 and PD-1/PD-L1 demonstrated higher response rates than either monotherapy, in different cancer types including melanoma ( 54, 55 ), hepatocellular carcinoma ( 56 ), renal cell carcinoma (RCC; refs.57, 58 ), NSCLC ( 59 ), malignant pleural mesothelioma ( 60 ), and colorectal cancer (MSI-H/dMMR; ref. 61 ).”
From The Next Decade of Immune Checkpoint Therapy (2021) · cites this paper as [55]
In the citing paper
“Long-term follow-up has demonstrated durable survival benefi t for a subset of patients with melanoma and RCC, and combination therapy with ICT is under active investigation for a number of tumor types ( 55,58 ).”
From The Next Decade of Immune Checkpoint Therapy (2021) · cites this paper as [55]
In the citing paper
“Anti-PD-1/PD-L1 agents pared with chemotherapy have also improved response rates and survival in many diseases including lung cancer, triple negative breast cancer, head and neck squamous cell carcinoma, and others.12–14”
From Endocrine toxicities of immune checkpoint inhibitors (2021) · cites this paper as [13]
In the citing paper
“The results of CheckMate-069, CheckMate-067, and CheckMate-142 showed that ipilimumab plus nivolumab significantly improved the outcomes of patients, relative to ipilimumab or nivolumab monotherapies [132–134].”
From Combination strategies with PD-1/PD-L1 blockade: current advances and future directions (2022) · cites this paper as [133]
In the citing paper
“Until now, the FDA has approved the ipilimumab plus nivolumab for melanoma, RCC, MSI-H/dMMR colorectal cancer, HCC, PD-L1 positive NSCLC, and malignant pleural mesothelioma (Table 5) [132–138].”
From Combination strategies with PD-1/PD-L1 blockade: current advances and future directions (2022) · cites this paper as [133]
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Epigenetic Mechanisms of Resistance to Immune Checkpoint Inhibitors
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The CD58-CD2 axis is co-regulated with PD-L1 via CMTM6 and shapes anti-tumor immunity
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Self-citationImmunosurveillance and Immunoediting of Lung Cancer: Current Perspectives and Challenges
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European consensus-based interdisciplinary guideline for melanoma. Part 2: Treatment – Update 2024
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Checkpoint inhibitors, fertility, pregnancy, and sexual life: a systematic review
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Rutella, S., Vadakekolathu, J. N., Mazziotta, F., Reeder, S., Yau, T. O., Mukhopadhyay, R., Dickins, B., Altmann, H., Krämer, M., Knaus, H. A., et al. (2022) · Journal of Clinical Investigation · doi:10.1172/jci159579 · Cited by 96
“IED gene sets served as a reliable biomarker to stratify OS after standardof-care therapy and ICB, both in AML and in melanoma (a paradigm for successful immunotherapy actualization) (16, 17).”
BackgroundReal World Outcomes of Ipilimumab and Nivolumab in Patients with Metastatic Melanoma
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Liu, J., Kong, X., Huang, T., Wang, R., Li, W., & Chen, Q. (2020) · Frontiers in Immunology · doi:10.3389/fimmu.2020.02048 · Cited by 93
van der Kooij, M. K., Suijkerbuijk, K. P. M., Aarts, M. J. B., van den Berkmortel, F. W. P. J., Blank, C. U., Boers‐Sonderen, M. J., van Breeschoten, J., van den Eertwegh, A. J. M., de Groot, J. W. B., Haanen, J. B. A. G., et al. (2021) · Annals of Internal Medicine · doi:10.7326/m20-3419 · Cited by 95
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“In SECOMBIT, patients were treated with combination anti-PD-1 and anti-CTLA-4.”
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Immune checkpoint inhibitors to treat cutaneous malignancies
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Cancer-Associated Angiogenesis: The Endothelial Cell as a Checkpoint for Immunological Patrolling
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Identifying key questions in the ecology and evolution of cancer
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Targeting regulatory T cells in anti‐PD‐1/PD‐L1 cancer immunotherapy
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“For decades, the immuno-oncology concept was thereafter investigated (7, 8) and ICIs have eventually proven only recently to prolong survival in patients with melanoma (9, 10), lung cancer (11, 12), urothelial carcinoma (13) and renal cancer (14), amongst others.”
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The ambiguous role of obesity in oncology by promoting cancer but boosting antitumor immunotherapy
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PD-1/PD-L1 Based Combinational Cancer Therapy: Icing on the Cake
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Boron Neutron Capture Therapy: Current Status and Challenges
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A high OXPHOS CD8 T cell subset is predictive of immunotherapy resistance in melanoma patients
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Rationale for LDH-targeted cancer immunotherapy
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“Data from the CheckMate-067 trial confirm this, showing lower 5-year PFS with nivolumab in patients with (largely V600E) BRAF-mutant melanoma than those with BRAF WT (22% v 32%) but a similar PFS with combination therapy (38% v 35%).(3) In our study, mutation status was insufficiently predictive to be included in our…”
ResultSelf-citationMelanoma Treatments and Mortality Rate Trends in the US, 1975 to 2019
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ERK and USP5 govern PD-1 homeostasis via deubiquitination to modulate tumor immunotherapy
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“Previous studies have demonstrated that combinational therapy of PD-1 and CTLA-4 blockade is more effective than monotherapy in preclinical mouse tumor models and clinical trials 42 – 44 .”
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Organoid Models for Precision Cancer Immunotherapy
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The oligometastatic spectrum in the era of improved detection and modern systemic therapy
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“Cancer immunotherapy using immune checkpoint inhibitors (ICIs) is now a core component in the treatment of most patients with advanced-stage cancer, and recently also in the early stages of cancer 13–19 .”
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Self-citation
Metadata
- Authors
- Larkin, J., Chiarion-Sileni, V., Gonzalez, R., Grob, J.-J., Rutkowski, P., Lao, C. D., Cowey, C. L., Schadendorf, D., Wagstaff, J., Dummer, R., Ferrucci, P. F., Smylie, M., Hogg, D., Hill, A., Márquez-Rodas, I., Haanen, J., Guidoboni, M., Maio, M., Schöffski, P., Carlino, M. S., Lebbé, C., McArthur, G., Ascierto, P. A., Daniels, G. A., Long, G. V., Bastholt, L., Rizzo, J. I., Balogh, A., Moshyk, A., Hodi, F. S., & Wolchok, J. D.
- Affiliations
- Royal Marsden NHS Foundation Trust (GB)
- From the Royal Marsden NHS Foundation Trust, London (J.L.), and the College of Medicine, Swansea University, Swansea (J.W.) — both in the United Kingdom; the Oncology Institute of Veneto IRCCS, Padua (V.C.-S.), the European Institute of Oncology, IRCCS, Milan (P.F.F.), Istituto Nazionale Tumori IRCCS Fondazione Pascale, Naples (P.A.A.), the Immunotherapy and Somatic Cell Therapy Unit, IRCCS Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori, Meldola (M.G.), and the Center for Immuno...
- University of Siena (IT)
- The University of Sydney (AU)
- ORCID
- Larkin, James
- Gonzalez, Rene
- Grob, Jean-Jacques
- Rutkowski, Piotr
- Schadendorf, Dirk
- Wagstaff, John
- Dummer, Reinhard
- Ferrucci, Pier F.
- Smylie, Michael
- Hogg, David
- Haanen, John
- Guidoboni, Massimo
- Maio, Michele
- Schöffski, Patrick
- Carlino, Matteo S.
- McArthur, Grant
- Ascierto, Paolo A.
- Daniels, Gregory A.
- Long, Georgina V.
- Bastholt, Lars
- Moshyk, Andriy
- Hodi, F. Stephen
- Wolchok, Jedd D.
- Venue
- New England Journal of Medicine
- Publisher
- Massachusetts Medical Society
- Published
- 2019-10-17
- Volume
- 381
- Issue
- 16
- Pages
- 1535-1546
- ISSN
- 0028-4793 (ISSN-L)
- 1533-4406
- OpenAlex
- W3043703771
- Cited by
- 3,723
- References
- 14
- Citations by year
- 2026: 257 · 2025: 366 · 2024: 560 · 2023: 656 · 2022: 693 · 2021: 712 · 2020: 453 · 2019: 18
- FWCI
- 195.72
- Type
- journal article
- Language
- en
- Open access
- bronze
- doi.org
- Locations
- New England Journal of Medicine (publishedVersion)
- Zurich Open Repository and Archive (University of Zurich) (acceptedVersion, other-oa)
- University of Southern Denmark Research Portal (University of Southern Denmark) (submittedVersion, other-oa)
- Universitätsbibliographie, Universität Duisburg-Essen (submittedVersion)
- Lirias (submittedVersion)
- Institutional Research Information System University of Ferrara (University of Ferrara) (submittedVersion, other-oa)
- Use Siena air (University of Siena) (submittedVersion)
- Zurich Open Repository and Archive (University of Zurich) (submittedVersion, other-oa)
- Zurich Open Repository and Archive (University of Zurich)
- Funders
- Amgen
- Bristol-Myers Squibb
- Eli Lilly and Company
- Pfizer
- AstraZeneca
- GlaxoSmithKline
- Sanofi
- Array BioPharma
- Regeneron Pharmaceuticals
- Massachusetts Medical Society
- Les Laboratories Pierre Fabre
- Incyte
- Syndax Pharmaceuticals
- National Institute for Health and Care Research
- Eisai
- Ipsen
- Plexxikon
- EUSA Pharma
- LEO Pharma
- Genentech
- EMD Serono
- Sanofi Genzyme
- Pharmacyclics
- National Cancer Institute (P30CA008748)
- Topics
- Health Sciences › Medicine › Oncology › Cancer Immunotherapy and Biomarkers
- Health Sciences › Medicine › Oncology › Cutaneous Melanoma Detection and Management
- Life Sciences › Biochemistry, Genetics and Molecular Biology › Molecular Biology › Melanoma and MAPK Pathways
- Keywords
- ipilimumab, advanced melanoma, combination immunotherapy, immune checkpoint inhibitors, five-year survival, overall survival, progression-free survival, long-term outcomes, health-related quality of life, CheckMate 067, PD-1 inhibitors, CTLA-4 inhibitors, immune-related adverse events
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