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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]
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]
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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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“…R/M HNSCC. Additionally, nivolumab plus ipilimumab had demonstrated long term, durable survival bene fi ts for various other cancers, including non – small cell lung cancer (NSCLC), melanoma, renal cell carcinoma, esophageal squamous cell carcinoma, and malignant pleural mesothelioma (38 – 42).”
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“The mechanisms of (1), (2) and (3) are induced by anomalies in steps 1– 3, 6, steps 4– 5, and 7 of T- cell activation, respectively.”
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“This is despite the original study that explored ICPI use in melanoma reporting that PD-L1 did not predict those in whom ICPI would lead to significant improved survival (15).”
BackgroundOxidative Stress in Melanoma: Beneficial Antioxidant and Pro-Oxidant Therapeutic Strategies
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“The combination of anti-PD-1/PD-L1 with anti-CTL-4 is another effective strategy that has been pursued with positive results in different solid tumors, showing an increased efficacy with a dual checkpoints inhibition [26,27,87,88].”
BackgroundProgresses in biomarkers for cancer immunotherapy
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Postow, M. A., Knox, S. J., Goldman, D. A., Elhanati, Y., Mavinkurve, V., Wong, P., Halpenny, D. F., Reddy, S. A., Vado, K., McCabe, D., et al. (2020) · Clinical Cancer Research · doi:10.1158/1078-0432.ccr-19-3936 · Cited by 49
Self-citationInnate Immune Cells and Their Contribution to T-Cell-Based Immunotherapy
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Oligometastasis: Past, Present, Future
Gutiontov, S. I., Pitroda, S. P., & Weichselbaum, R. R. (2020) · International Journal of Radiation Oncology*Biology*Physics · doi:10.1016/j.ijrobp.2020.02.019 · Cited by 50
Pepermans, R. A., Sharma, G., & Prossnitz, E. R. (2021) · Cells · doi:10.3390/cells10030672 · Cited by 53
Ellebæk, E., Svane, I. M., Schmidt, H., Haslund, C. A., Donia, M., Hoejberg, L., Ruhlmann, C. H. B., Guldbrandt, L. M., Køhler, U. H., & Bastholt, L. (2021) · Cancer Epidemiology · doi:10.1016/j.canep.2021.101943 · Cited by 48
Self-citationReynolds, K. L., Arora, S., Elayavilli, R. K., Louv, W. C., Schaller, T. H., Khandelwal, A., Rothenberg, M. L., Khozin, S., Guidon, A. C., Dougan, M. L., et al. (2021) · Journal for ImmunoTherapy of Cancer · doi:10.1136/jitc-2021-002896 · Cited by 48
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The dark side of immunotherapy
Okwundu, N., Grossman, D., Hu‐Lieskovan, S., Grossmann, K. F., & Swami, U. (2021) · Annals of Translational Medicine · doi:10.21037/atm-20-4750 · Cited by 48
Metabolic Reprogramming in the Tumor Microenvironment With Immunocytes and Immune Checkpoints
Xu, Y., He, L., Fu, Q., & Hu, J. (2021) · Frontiers in Oncology · doi:10.3389/fonc.2021.759015 · Cited by 51
“In TNBC patients, the response to PD-1 inhibitors is also relatively moderate (19%) (7).”
BackgroundLuby, A., & Alves‐Guerra, M. (2021) · Cancers · doi:10.3390/cancers13235912 · Cited by 49
“In addition, there are currently immunotherapy strategies based on the use of monoclonal antibodies that neutralize immune checkpoints, but again the success of these treatments is limited to some patients and types of cancer [18].”
BackgroundRNF31 inhibition sensitizes tumors to bystander killing by innate and adaptive immune cells
Zhang, Z., Kong, X., Ligtenberg, M. A., Veen, S. E. V. H.-V., Visser, N. L., de Bruijn, B., Stecker, K. E., van der Helm, P. W., Kuilman, T., Hoefsmit, E. P., et al. (2022) · Cell Reports Medicine · doi:10.1016/j.xcrm.2022.100655 · Cited by 48
“Immune checkpoint blockade (ICB) and adoptive T cell transfer therapies serve to (re-)invigorate tumor-specific CD8 T cell function.(1,2) However, for melanoma, but more frequently for other cancer indications, either primary or acquired resistance limits overall and durable patient benefit.”
BackgroundWhat is the status of immunotherapy in thyroid neoplasms?
García‐Álvarez, A., Hernando, J., Carmona-Alonso, A., & Capdevila, J. (2022) · Frontiers in Endocrinology · doi:10.3389/fendo.2022.929091 · Cited by 47
Natural Killer Cell-Based Immunotherapy against Glioblastoma
Morimoto, T., Nakazawa, T., Maeoka, R., Nakagawa, I., Tsujimura, T., & Matsuda, R. (2023) · International Journal of Molecular Sciences · doi:10.3390/ijms24032111 · Cited by 51
Neoadjuvant therapy in non-small cell lung cancer
Grant, C., Hagopian, G. G., & Nagasaka, M. (2023) · Critical Reviews in Oncology/Hematology · doi:10.1016/j.critrevonc.2023.104080 · Cited by 47
Imaging immune checkpoint networks in cancer tissues with supermultiplexed SERS nanoprobes
Li, J., Liu, F., Bi, X., & Ye, J. (2023) · Biomaterials · doi:10.1016/j.biomaterials.2023.122327 · Cited by 48
Biomarkers and computational models for predicting efficacy to tumor ICI immunotherapy
Qin, Y., Huo, M., Liu, X., & Li, S. C. (2024) · Frontiers in Immunology · doi:10.3389/fimmu.2024.1368749 · Cited by 51
“Compared to conventional treatments, tumor immunotherapy has exhibited longer-lasting effects (2 – 4).”
BackgroundPersonalized, autologous neoantigen-specific T cell therapy in metastatic melanoma: a phase 1 trial
Borgers, J. S. W., Lenkala, D., Kohler, V. L., Jackson, E. K., Linssen, M. D., Hymson, S., McCarthy, B. J., Cosgrove, E., Balogh, K. N., Esaulova, E., et al. (2025) · Nature Medicine · doi:10.1038/s41591-024-03418-4 · Cited by 50
Self-citationModern Aspects of Immunotherapy with Checkpoint Inhibitors in Melanoma
Petrova, V., Arkhypov, I., Weber, R., Groth, C., Altevogt, P., Utikal, J. S., & Umansky, V. (2020) · International Journal of Molecular Sciences · doi:10.3390/ijms21072367 · Cited by 50
Rose, A. A. N., Armstrong, S. M., Hogg, D., Butler, M. O., Saibil, S. D., Arteaga, D. P., Muniz, T. P., Kelly, D., Ghazarian, D., King, I. F. G., et al. (2021) · Journal for ImmunoTherapy of Cancer · doi:10.1136/jitc-2020-001642 · Cited by 48
Self-citationBlankenstein, S. A., Rohaan, M. W., Klop, W. M. C., van der Hiel, B., van de Wiel, B. A., Lahaye, M. J., Adriaansz, S., Sikorska, K., van Tinteren, H., Sari, A., et al. (2021) · Annals of Surgery · doi:10.1097/sla.0000000000004893 · Cited by 48
Self-citationThe deacylase SIRT5 supports melanoma viability by influencing chromatin dynamics
Giblin, W., Bringman, L. R., Guo, A. H., Kumar, S., Monovich, A. C., Mostafa, A. M., Skinner, M. E., Azar, M., Mady, A. S. A., Chung, C. H., et al. (2021) · Journal of Clinical Investigation · doi:10.1172/jci138926 · Cited by 47
Du, K., Wei, S., Wei, Z., Frederick, D. T., Miao, B., Moll, T. O. C., Tian, T., Sugarman, E. T., Gabrilovich, D. I., Sullivan, R. J., et al. (2021) · Nature Communications · doi:10.1038/s41467-021-26299-4 · Cited by 49
Kudchadkar, R. R., Lowe, M., Khan, M. K., & McBrien, S. (2020) · CA A Cancer Journal for Clinicians · doi:10.3322/caac.21599 · Cited by 47
Wessely, A., Steeb, T., Berking, C., & Heppt, M. V. (2021) · International Journal of Molecular Sciences · doi:10.3390/ijms22115761 · Cited by 49
Ruysscher, D. D., Ramalingam, S. S., Urbanic, J. J., Gerber, D. E., Tan, D. S. W., Cai, J., Li, A., & Peters, S. (2021) · Clinical Lung Cancer · doi:10.1016/j.cllc.2021.07.005 · Cited by 49
Rubio‐Infante, N., Ramírez‐Flores, Y. A., Castillo, E. C., Lozano, O., García‐Rivas, G., & Torre‐Amione, G. (2022) · Frontiers in Cell and Developmental Biology · doi:10.3389/fcell.2022.851032 · Cited by 48
Cancer Cell Phenotype Plasticity as a Driver of Immune Escape in Melanoma
Benboubker, V., Boivin, F., Dalle, S., & Caramel, J. (2022) · Frontiers in Immunology · doi:10.3389/fimmu.2022.873116 · Cited by 51
“Despite spectacular efficacy of immune checkpoint blockade (ICB) (anti-CTLA-4 and anti-PD-1 antibodies) in a subset of metastatic melanoma patients (2), primary (i.”
BackgroundMechanisms of Immunotherapy Resistance in Cutaneous Melanoma: Recognizing a Shapeshifter
Thornton, J., Chhabra, G., Singh, C. K., Guzmán‐Pérez, G., Shirley, C. A., & Ahmad, N. (2022) · Frontiers in Oncology · doi:10.3389/fonc.2022.880876 · Cited by 55
Rohaan, M. W., Gomez-Eerland, R., van den Berg, J. H., Foppen, M. H. G., van Zon, M., Raud, B., Jedema, I., Scheij, S., de Boer, R., Bakker, N. A. M., et al. (2022) · Immuno-Oncology Technology · doi:10.1016/j.iotech.2022.100089 · Cited by 46
Self-citationCancer Immunotherapy and Delivery System: An Update
Yang, M. J., Olaoba, O. T., Zhang, C., Kimchi, E. T., Staveley-O’Carroll, K. F., & Li, G. (2022) · Pharmaceutics · doi:10.3390/pharmaceutics14081630 · Cited by 46
Chen, L. N., & Carvajal, R. D. (2022) · Expert Review of Anticancer Therapy · doi:10.1080/14737140.2022.2124971 · Cited by 52
“They also remain considerably worse when compared to the outcomes of checkpoint inhibitor therapy for cutaneous melanoma [31,32].”
ResultNakamura, Y., Namikawa, K., Kiniwa, Y., Kato, H., Yamasaki, O., Yoshikawa, S., Maekawa, T., Matsushita, S., Takenouchi, T., Inozume, T., et al. (2022) · European Journal of Cancer · doi:10.1016/j.ejca.2022.08.030 · Cited by 46
Taylor, J., Gandhi, A., Gray, E. S., & Zaenker, P. (2023) · Frontiers in Immunology · doi:10.3389/fimmu.2022.991433 · Cited by 47
“Among melanoma patients, more than 50% who undergo treatment with ICIs experience severe grade (grade 3-5) irAEs (9).”
BackgroundThe Latest Option: Nivolumab and Relatlimab in Advanced Melanoma
Albrecht, L. J., Livingstone, E., Zimmer, L., & Schadendorf, D. (2023) · Current Oncology Reports · doi:10.1007/s11912-023-01406-4 · Cited by 49
Self-citationAkkermansia muciniphila: a potential booster to improve the effectiveness of cancer immunotherapy
Fan, S., Jiang, Z., Zhang, Z., Xing, J., Wang, D., & Tang, D. (2023) · Journal of Cancer Research and Clinical Oncology · doi:10.1007/s00432-023-05199-8 · Cited by 51
Current Development Status of Cytokines for Cancer Immunotherapy
Song, K. (2023) · Biomolecules & Therapeutics · doi:10.4062/biomolther.2023.196 · Cited by 48
“Sometimes, it can directly target the cancers (Larkin et al ., 2019).”
Shen, S., Hong, Y., Huang, J., Qu, X., Sooranna, S. R., Lu, S., Li, T. X., & Niu, B. (2024) · Cytokine & Growth Factor Reviews · doi:10.1016/j.cytogfr.2024.08.001 · Cited by 46
Immune checkpoint inhibitors and the liver: balancing therapeutic benefit and adverse events
Martin, E. D., Fulgenzi, C. A. M., Celsa, C., Laurent-Bellue, A., Torkpour, A., Lombardi, P., D’Alessio, A., & Pinato, D. J. (2024) · Gut · doi:10.1136/gutjnl-2024-332125 · Cited by 51
“78 The safety and efficacy 63 65 153 154 Impaired liver function tests Association with: high AST and ALT at baseline level and low APL baseline level (ALP in particular for hepatocellular liver damage) Da et al , Kawano et al 154 155 Malignant melanoma Reported in only one study, possibly due to…”
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Photochemical Internalization: Light Paves Way for New Cancer Chemotherapies and Vaccines
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Immunotherapy Potentiates the Effect of Chemotherapy in Metastatic Melanoma—A Retrospective Study
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Treatment of immune checkpoint inhibitor-induced inflammatory arthritis
Jeurling, S., & Cappelli, L. C. (2020) · Current Opinion in Rheumatology · doi:10.1097/bor.0000000000000701 · Cited by 47
König, D., & Laubli, H. P. (2020) · Pharmacology · doi:10.1159/000509081 · Cited by 49
The role of opioids in cancer response to immunotherapy
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Adolescents and Young Adults Living With an Uncertain or Poor Cancer Prognosis: The “New” Lost Tribe
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FDG-PET to predict long-term outcome from anti-PD-1 therapy in metastatic melanoma
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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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