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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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“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]
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
“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]
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“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]
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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]
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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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“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]
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“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 measuredIn 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]
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“A recently published study demonstrated that a combination of lirilumab with pembrolizumab or nivolumab with ipilimumab as “dual immunotherapy” for patients with non-small-cell lung carcinoma or melanoma, respectively, had additive effects promoting both ADCC and the response rate in comparison with monotherapy [47, 9…”
ResultImmune Microenvironment and Immunotherapies for Diffuse Intrinsic Pontine Glioma
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“These criteria may include progression of the disease, lack of response, treatment intolerance or adverse events, and disease recurrence after an initial response [35].”
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“60% after nivolumab and ipilimumab (26)).”
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“More specifically immunotherapy trials involving patients with advanced (stage III or IV), unresectable disease noted a PFS over a comparable time period in the 40-50% range (25, 26).”
BackgroundAdegoke, N. A., Gide, T. N., Mao, Y., Quek, C. Y. J., Patrick, E., Carlino, M. S., Lo, S., Menzies, A. M., da Silva, I. P., Vergara, I. A., et al. (2023) · Journal for ImmunoTherapy of Cancer · doi:10.1136/jitc-2023-007144 · Cited by 30
“5 However, despite these”
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“For example, although combination therapy with anti-PD-1 antibody nivolumab and anti-CTLA-4 antibody ipilimumab has been demonstrated to have therapeutic effects on overall survival outcomes in patients with advanced melanoma 84,85 , only a few patients can bene fi t from this treatment.”
BackgroundImmunotherapy in melanoma: advances, pitfalls, and future perspectives
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Innate Immune Cells in Melanoma: Implications for Immunotherapy
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Self-citationFc Effector Function of Immune Checkpoint Blocking Antibodies in Oncology
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Circulating MicroRNAs: functional biomarkers for melanoma prognosis and treatment
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“In the phase 3 Check-Mate 067 clinical trial, 5-year PFS and OS rates were 36% and 52%, respectively, in patients with advanced melanoma receiving combination nivolumab and ipilimumab [100].”
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Management of cancer patients during COVID-19 pandemic at developing countries
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van Breeschoten, J., Wouters, M. W. J. M., Hilarius, D. L., Haanen, J. B. A. G., Blank, C. U., Aarts, M. J. B., van den Berkmortel, F. W. P. J., de Groot, J. B., Hospers, G. A. P., Kapiteijn, E., et al. (2021) · British Journal of Cancer · doi:10.1038/s41416-020-01229-1 · Cited by 27
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PD-1 Blockade for Hepatocellular Carcinoma: Current Research and Future Prospects
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Zimmer, L., Livingstone, E., Krackhardt, A. M., Schultz, E. S., Göppner, D., Assaf, C., Trebing, D., Stelter, K., Windemuth-Kieselbach, C., Ugurel, S., et al. (2021) · European Journal of Cancer · doi:10.1016/j.ejca.2021.09.011 · Cited by 27
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“In melanoma, both ICI and targeted therapies are considered first-line options for Class I disease based on robust overall response rates [47, 48].”
BackgroundGenetic characterization of advanced conjunctival melanoma and response to systemic treatment
Lodde, G. C., Jansen, P., Möller, I., Sucker, A., Hassel, J. C., Forschner, A., Eckardt, J., Meier, F. E., Reinhardt, L., Kähler, K. C., et al. (2022) · European Journal of Cancer · doi:10.1016/j.ejca.2022.01.008 · Cited by 27
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Burgers, V. W. G., van den Bent, M. J., Dirven, L., Lalisang, R. I., Tromp, J. M., Compter, A., Kouwenhoven, M. C. M., Bos, M. E. M. M., Langen, A. J. D., Reuvers, M. J. P., et al. (2022) · Frontiers in Oncology · doi:10.3389/fonc.2022.994934 · Cited by 27
Nanodelivery systems for cutaneous melanoma treatment
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Drug dependence in cancer is exploitable by optimally constructed treatment holidays
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Trager, M. H., Coley, S. M., Dube, G. K., Khan, S. A., Ingham, M. A., Samie, F. H., Geskin, L. J., McDonnell, D. E., Brouder, D., Saenger, Y. M., et al. (2020) · Journal for ImmunoTherapy of Cancer · doi:10.1136/jitc-2020-000908 · Cited by 27
Management of cutaneous melanoma: radiologists challenging and risk assessment
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Self-citationAdvances in adoptive T-cell therapy for metastatic melanoma
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“However, only 20-50% of patients with advanced melanoma experience durable responses to immune checkpoint inhibitors (60, 61).”
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Emerging Ocular Side Effects of Immune Checkpoint Inhibitors: A Comprehensive Review
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“[11,12].”
InfluentialPulmonary metastasectomy in the era of targeted therapy and immunotherapy
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Chemokine biology on immune checkpoint–targeted therapies
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Targeting glyco-immune checkpoints for cancer therapy
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Ipilimumab in a real‐world population: A prospective Phase IV trial with long‐term follow‐up
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Effects of exercise and anti-PD-1 on the tumour microenvironment
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Targeting cytokines and immune checkpoints in atherosclerosis with monoclonal antibodies
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Imaging findings of malignant skin tumors: radiological–pathological correlation
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“Although cMMs are associated with poor prognosis, the 5-year overall survival is reaching 52% in patients with cMM using nivolumab-plus-ipilimumab [48].”
BackgroundOptimal systemic therapy for high-risk resectable melanoma
Eggermont, A. M. M., Hamid, O., Long, G. V., & Luke, J. J. (2022) · Nature Reviews Clinical Oncology · doi:10.1038/s41571-022-00630-4 · Cited by 26
Self-citationTriplet Therapy in Melanoma — Combined BRAF/MEK Inhibitors and Anti-PD-(L)1 Antibodies
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“Another group of interest is the good-prognosis low-volume disease, normal LDH group, who may not derive major overall survival benefit from the addition of ipilimumab to single-agent nivolumab [8].”
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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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