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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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“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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“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]
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“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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“INTRODUCTION Antibodies binding the checkpoint proteins CTLA-4 (cytotoxic T lymphocyte–associated protein-4) and PD-1 (programmed cell death protein-1), commonly referred to as immune checkpoint blockade (ICB), have revolutionized the treatment of metastatic melanoma (MM) and numerous other cancers (1, 2).”
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“However, almost two-thirds of patients with melanoma treated with CPI therapy will eventually progress within 5 years [8].”
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“4,5 8 How to efficiently and accurately screen cancer populations that are validated for immunotherapy is currently an essential research direction to prolong the survival of these patients.”
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“CTLA-4 blockade has shown durable results in many types of cancer including melanoma, NSCLC, and renal cell carcinoma (RCC), possibly secondary to intratumoral Treg depletion [75, 96, 97].”
Melanoma brain metastases – Interdisciplinary management recommendations 2020
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Memory-like Differentiation Enhances NK Cell Responses to Melanoma
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Implantable optical fibers for immunotherapeutics delivery and tumor impedance measurement
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Combining immune checkpoint inhibitors with chemotherapy in advanced solid tumours: A review
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Effect of corticosteroid dosing on outcomes in high‐grade immune checkpoint inhibitor hepatitis
Li, M., Wong, D., Vogel, A. S., Sack, J., Rahma, O. E., Hodi, F. S., Zucker, S. D., & Grover, S. (2021) · Hepatology · doi:10.1002/hep.32215 · Cited by 73
Self-citationControl of Dendritic Cell Function Within the Tumour Microenvironment
Hari‐Gupta, Y., Khanom, A., & Acton, S. E. (2022) · Frontiers in Immunology · doi:10.3389/fimmu.2022.733800 · Cited by 73
The Current State of Treatment and Future Directions in Cutaneous Malignant Melanoma
Ernst, M. K., & Giubellino, A. (2022) · Biomedicines · doi:10.3390/biomedicines10040822 · Cited by 78
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Tumor Vaccines: Unleashing the Power of the Immune System to Fight Cancer
Liu, D., Che, X., Wang, X., Ma, C., & Wu, G. (2023) · Pharmaceuticals · doi:10.3390/ph16101384 · Cited by 84
The immune checkpoint receptor LAG3: Structure, function, and target for cancer immunotherapy
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“Exhausted T cells are unresponsive to pMHC. Based on this discovery, T cell immune checkpoint receptors are currently major therapeutic targets in cancer, with monoclonal antibodies (mAbs) that block CTLA4 and PD1/PDL1 in the clinic since 2010 (5, 6).”
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Babačić, H., Lehtiö, J., de Coaña, Y. P., Pernemalm, M., & Eriksson, H. (2020) · Journal for ImmunoTherapy of Cancer · doi:10.1136/jitc-2019-000204 · Cited by 72
Ascierto, P. A., Vecchio, M. D., Mackiewicz, A. A., Robert, C., Chiarion‐Sileni, V., Arance, A. M., Lebbé, C., Svane, I. M., McNeil, C. M., Rutkowski, P. L., et al. (2020) · Journal for ImmunoTherapy of Cancer · doi:10.1136/jitc-2019-000391 · Cited by 71
Self-citationB Cells in Patients With Melanoma: Implications for Treatment With Checkpoint Inhibitor Antibodies
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Agnostic Approvals in Oncology: Getting the Right Drug to the Right Patient with the Right Genomics
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“39 42 However, PD-1/PD-L1 blockade therapy exhibits effectiveness in only a subset of patients with specific tumour types, including non-small-cell lung cancer, melanoma, bladder cancer, and kidney cancer.”
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PRMT7 ablation stimulates anti-tumor immunity and sensitizes melanoma to immune checkpoint blockade
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Self-citationPrognostic and Predictive Factors in Advanced Head and Neck Squamous Cell Carcinoma
Magnes, T., Wagner, S. M., Kiem, D., Weiß, L., Rinnerthaler, G., Greil, R., & Melchardt, T. (2021) · International Journal of Molecular Sciences · doi:10.3390/ijms22094981 · Cited by 74
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“20 21 Therefore, an unmet clinical need for other immunotherapies exists.”
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The microenvironment in myeloma
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Comprehensive analysis of cutaneous and uveal melanoma liver metastases
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Self-citationVirus-specific memory T cell responses unmasked by immune checkpoint blockade cause hepatitis
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MHC Class I Deficiency in Solid Tumors and Therapeutic Strategies to Overcome It
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Immune checkpoint blockade in HIV
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“The addition of an anti-CTLA-4 antibody to PD-1 blockade increases the objective response rate (ORR), which can often be translated into a longer duration of response (DoR) and survival [4, 5].”
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Immune checkpoint inhibitors in patients with pre-existing psoriasis: safety and efficacy
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Self-citationAssociation of Quality-of-Life Outcomes in Cancer Drug Trials With Survival Outcomes and Drug Class
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Efficacy of anti-PD-1 and ipilimumab alone or in combination in acral melanoma
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Self-citationImmune checkpoint inhibitors in melanoma in the metastatic, neoadjuvant, and adjuvant setting
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The Role of PTEN Loss in Immune Escape, Melanoma Prognosis and Therapy Response
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Bispecific Targeting of PD-1 and PD-L1 Enhances T-cell Activation and Antitumor Immunity
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A multicenter characterization of hepatitis associated with immune checkpoint inhibitors
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Self-citationParra, E. R., Ferrufino‐Schmidt, M. C., Tamegnon, A., Zhang, J., Solis, L. M., Jiang, M., Ibarguen, H. P., Haymaker, C., Lee, J. J., Bernatchez, C., et al. (2021) · Scientific Reports · doi:10.1038/s41598-021-88156-0 · Cited by 66
DNA methylation-based prediction of response to immune checkpoint inhibition in metastatic melanoma
Filipski, K., Scherer, M., Zeiner, K. N., Bucher, A. M., Kleemann, J., Jurmeister, P. S., Hartung, T. I., Meißner, M., Plate, K. H., Fenton, T. R., et al. (2021) · Journal for ImmunoTherapy of Cancer · doi:10.1136/jitc-2020-002226 · Cited by 64
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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