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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.
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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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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]
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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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“Besides, A clinical trial reported the 5-year outcomes that nivolumab (anti-PD-1) combined with ipilimumab (anti-CTLA-4) among advanced melanoma patients has resulted in sustained long-term progression-free and overall survival (52%) compared with nivolumab group (44%) and ipilimumab group (26%) (75).”
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“As a monotherapy, ICB can yield beneficial and long-term therapeutic responses in patients with various types of cancer, with response rates ranging from 10 to 58% [4–6].”
BackgroundMismatch repair deficiency is not sufficient to elicit tumor immunogenicity
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“INTRODUCTION Immune checkpoint inhibitors have transformed the treatment landscape for patients with advanced melanoma.(1,2) However, despite the availability of effective immunotherapies, treatment for patients with melanoma that had progressed while on anti– programmed death (PD)-ligand (L)-containing therapies rema…”
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Self-citationPreserving the CTLA-4 Checkpoint for Safer and More Effective Cancer Immunotherapy
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Neoadjuvant immunotherapy for non–small cell lung cancer: State of the art
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Barriers and opportunities in pancreatic cancer immunotherapy
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“Cancer immunotherapeutic approaches, including immune check-pointblockade(ICB),chimericantigenreceptor(CAR)T-celltherapies,and cancer vaccines, have achieved signi fi cant advancements in treating various cancers 6 – 8 , such as melanoma, lung cancer, renal cell carcinoma, and lymphoma 9 – 12 .”
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“Nowadays, the 30% long-term survivors with anti-PD1 monotherapy and the 50% with anti-CTLA4 plus anti-PD1 combination, are emblematic of how immunotherapy has changed the prognostic landscape of MM [2].”
CD8+ T cell exhaustion and cancer immunotherapy
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Immune Checkpoint Inhibitor Therapy Aggravates T Cell–Driven Plaque Inflammation in Atherosclerosis
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NRAS mutant melanoma: Towards better therapies
Randic, T., Kozar, I., Margue, C., Utikal, J. S., & Kreis, S. (2021) · Cancer Treatment Reviews · doi:10.1016/j.ctrv.2021.102238 · Cited by 170
Resident memory CD8+ T cells in regional lymph nodes mediate immunity to metastatic melanoma
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The New Era of Immunotherapy in Gastric Cancer
Takei, S., Kawazoe, A., & Shitara, K. (2022) · Cancers · doi:10.3390/cancers14041054 · Cited by 155
The molecular and functional landscape of resistance to immune checkpoint blockade in melanoma
Lim, S. Y., Shklovskaya, E., Lee, J., Pedersen, B., Stewart, A., Ming, Z., Irvine, M., Shivalingam, B., Saw, R. P. M., Menzies, A. M., et al. (2023) · Nature Communications · doi:10.1038/s41467-023-36979-y · Cited by 161
“differentiation, (2) the disruption of antigen presentation via multiple inde-”
BackgroundSelf-citationWhy do patients with cancer die?
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“Further studies are needed to explore this possibility.”
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“In terms of therapeutic efficacy, anti–CTLA-4 plus anti–PD-1 combination therapy is considered the most effective immunotherapy strategy (5).”
Anti-PD-1 and Novel Combinations in the Treatment of Melanoma—An Update
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In vivo dendritic cell reprogramming for cancer immunotherapy
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“Next, we investigated in vivo cDC1 reprogramming as monotherapy or in combination with either anti-PD-1 or anti-CTLA-4 using B16, B2905 and the additional melanoma model YUMM1.”
InfluentialTumor Microenvironment: Implications in Melanoma Resistance to Targeted Therapy and Immunotherapy
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The gut microbiome: what the oncologist ought to know
Lee, K. A., Luong, M., Shaw, H. M., Nathan, P., Bataille, V. A., & Spector, T. D. (2021) · British Journal of Cancer · doi:10.1038/s41416-021-01467-x · Cited by 154
Tissue-specific Tregs in cancer metastasis: opportunities for precision immunotherapy
Huppert, L. A., Green, M. D., Kim, L., Chow, C., Leyfman, Y., DAUD, A. I., & Lee, J. (2021) · Cellular and Molecular Immunology · doi:10.1038/s41423-021-00742-4 · Cited by 150
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Considerations for treatment duration in responders to immune checkpoint inhibitors
Marron, T. U., Ryan, A. E., Reddy, S. M., Kaczanowska, S., Younis, R. H., Thakkar, D., Zhang, J., Bartkowiak, T., Howard, R., Anderson, K. G., et al. (2021) · Journal for ImmunoTherapy of Cancer · doi:10.1136/jitc-2020-001901 · Cited by 137
Intratumoral Immunotherapy: From Trial Design to Clinical Practice
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Evolution of delayed resistance to immunotherapy in a melanoma responder
Liu, D., Lin, J., Robitschek, E. J., Kasumova, G. G., Heyde, A., Shi, A., Kraya, A., Zhang, G., Moll, T. O. C., Frederick, D. T., et al. (2021) · Nature Medicine · doi:10.1038/s41591-021-01331-8 · Cited by 139
Immunotherapy for nasopharyngeal carcinoma: Current status and prospects (Review)
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Self-citationOverall Survival and Response with Nivolumab and Relatlimab in Advanced Melanoma
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Self-citationToll-Like Receptor 9 Agonists in Cancer
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Circadian control of tumor immunosuppression affects efficacy of immune checkpoint blockade
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“Ipilimumab and tremelimumab have been approved for adjuvant therapy of melanoma [61].”
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Increasing cure rates of solid tumors by immune checkpoint inhibitors
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“Of the ICI-based regimens approved for metastatic and recurrent melanoma, the combination therapy with nivolumab and ipilimumab [72, 73] is preferred over single-agent pembrolizumab [74] or nivolumab [75] because of improved efficacy.”
BackgroundAptamers: Cutting edge of cancer therapies
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Self-citationMolecular Pathways and Mechanisms of LAG3 in Cancer Therapy
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The deubiquitinase USP22 regulates PD-L1 degradation in human cancer cells
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Significance of Tumor Mutation Burden in Immune Infiltration and Prognosis in Cutaneous Melanoma
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CD5 expression by dendritic cells directs T cell immunity and sustains immunotherapy responses
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“Melanoma is a prominent example of immune checkpoint blockade (ICB) success, with more than 50% of patients responding to dual anti–programmed cell death protein 1 (PD-1) and anti–cytotoxic T lymphocyte–associated protein 4 (CTLA-4) regimens (1, 2).”
Background
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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