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Nivolumab in Previously Untreated Melanoma without BRAF Mutation
Open accessAbstract
BACKGROUND: Nivolumab was associated with higher rates of objective response than chemotherapy in a phase 3 study involving patients with ipilimumab-refractory metastatic melanoma. The use of nivolumab in previously untreated patients with advanced melanoma has not been tested in a phase 3 controlled study. METHODS: We randomly assigned 418 previously untreated patients who had metastatic melanoma without a BRAF mutation to receive nivolumab (at a dose of 3 mg per kilogram of body weight every 2 weeks and dacarbazine-matched placebo every 3 weeks) or dacarbazine (at a dose of 1000 mg per square meter of body-surface area every 3 weeks and nivolumab-matched placebo every 2 weeks). The primary end point was overall survival. RESULTS: At 1 year, the overall rate of survival was 72.9% (95% confidence interval [CI], 65.5 to 78.9) in the nivolumab group, as compared with 42.1% (95% CI, 33.0 to 50.9) in the dacarbazine group (hazard ratio for death, 0.42; 99.79% CI, 0.25 to 0.73; P<0.001). The median progression-free survival was 5.1 months in the nivolumab group versus 2.2 months in the dacarbazine group (hazard ratio for death or progression of disease, 0.43; 95% CI, 0.34 to 0.56; P<0.001). The objective response rate was 40.0% (95% CI, 33.3 to 47.0) in the nivolumab group versus 13.9% (95% CI, 9.5 to 19.4) in the dacarbazine group (odds ratio, 4.06; P<0.001). The survival benefit with nivolumab versus dacarbazine was observed across prespecified subgroups, including subgroups defined by status regarding the programmed death ligand 1 (PD-L1). Common adverse events associated with nivolumab included fatigue, pruritus, and nausea. Drug-related adverse events of grade 3 or 4 occurred in 11.7% of the patients treated with nivolumab and 17.6% of those treated with dacarbazine. CONCLUSIONS: Nivolumab was associated with significant improvements in overall survival and progression-free survival, as compared with dacarbazine, among previously untreated patients who had metastatic melanoma without a BRAF mutation. (Funded by Bristol-Myers Squibb; CheckMate 066 ClinicalTrials.gov number, NCT01721772.).
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“however responses to these therapies are often heterogeneous and not durable (1–3).”
From Gut microbiome modulates response to anti-PD-1 immunotherapy in melanoma patients (2018) · cites this paper as [3]
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“Treatment with immunotherapy targeting checkpoint inhibitors PD-1 or CTLA-4 significantly increases survival in patients with metastatic melanoma over other standards of care [1, 2]”
From Relating the gut metagenome and metatranscriptome to immunotherapy responses in melanoma patients (2019) · cites this paper as [1]
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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 [2]
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“Nevertheless, the responses to ICI treatment have still been observed in those with low or undetectable levels of PD-L1 expression.9”
From The Diversity of Gut Microbiome is Associated With Favorable Responses to Anti–Programmed Death 1 Immunotherapy in Chinese Patients With NSCLC (2019) · cites this paper as [9]
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“Immune checkpoint blockade with monoclonal antibodies (mAbs) targeting programmed cell death protein 1 (PD-1) provides long-term clinical benefits to nearly 40% of patients with advanced melanoma (1–5).”
From Fecal microbiota transplant overcomes resistance to anti–PD-1 therapy in melanoma patients (2021) · cites this paper as [3]
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“Response rates range from 15 to 30% (in most solid tumors) to 45–60% (in melanoma and MSI-H tumors).”
From Immune-related adverse events and anti-tumor efficacy of immune checkpoint inhibitors (2019) · cites this paper as [1]
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New response evaluation criteria in solid tumours: revised RECIST guideline (version 1.1)
Eisenhauer, E. A., Therasse, P., Bogaerts, J., Schwartz, L. H., Sargent, D., Ford, R., Dancey, J., Arbuck, S., Gwyther, S., Mooney, M., et al. (2009) · European Journal of Cancer · doi:10.1016/j.ejca.2008.10.026 · Cited by 29,534
Improved Survival with Ipilimumab in Patients with Metastatic Melanoma
Hodi, F. S., O'Day, S. J., McDermott, D. F., Weber, R. W., Sosman, J. A., Haanen, J. B., Gonzalez, R., Robert, C., Schadendorf, D., Hassel, J. C., et al. (2010) · New England Journal of Medicine · doi:10.1056/nejmoa1003466 · Cited by 15,155
Self-citationSafety, activity, and immune correlates of anti–PD-1 antibody in cancer
Topalian, S. L., Hodi, F. S., Brahmer, J. R., Gettinger, S. N., Smith, D. C., McDermott, D. F., Powderly, J. D., Carvajal, R. D., Sosman, J. A., Atkins, M. B., et al. (2012) · New England Journal of Medicine · doi:10.1056/nejmoa1200690 · Cited by 12,628
Improved survival with vemurafenib in melanoma with BRAF V600E mutation
Chapman, P. B., Hauschild, A., Robert, C., Haanen, J. B., Ascierto, P., Larkin, J., Dummer, R., Garbe, C., Testori, A., Maio, M., et al. (2011) · New England Journal of Medicine · doi:10.1056/nejmoa1103782 · Cited by 7,720
Self-citationIpilimumab plus Dacarbazine for Previously Untreated Metastatic Melanoma
Robert, C., Thomas, L., Bondarenko, I., O'Day, S., Weber, J., Garbe, C., Lebbe, C., Baurain, J.-F., Testori, A., Grob, J.-J., et al. (2011) · New England Journal of Medicine · doi:10.1056/nejmoa1104621 · Cited by 4,496
Self-citationNivolumab plus Ipilimumab in Advanced Melanoma
Wolchok, J. D., Kluger, H., Callahan, M. K., Postow, M. A., Rizvi, N. A., Lesokhin, A. M., Segal, N. H., Ariyan, C. E., Gordon, R.-A., Reed, K., et al. (2013) · New England Journal of Medicine · doi:10.1056/nejmoa1302369 · Cited by 4,230
Self-citationHauschild, A., Grob, J., Демидов, Л. В., Jouary, T., Gutzmer, R., Millward, M. J., Rutkowski, P. L., Blank, C. U., Miller, W. H., Kaempgen, E., et al. (2012) · The Lancet · doi:10.1016/s0140-6736(12)60868-x · Cited by 3,050
Self-citationTopalian, S. L., Sznol, M., McDermott, D. F., Kluger, H. M., Carvajal, R. D., Sharfman, W. H., Brahmer, J. R., Lawrence, D. P., Atkins, M. B., Powderly, J. D., et al. (2014) · Journal of Clinical Oncology · doi:10.1200/jco.2013.53.0105 · Cited by 2,222
Improved Survival with MEK Inhibition in BRAF-Mutated Melanoma
Flaherty, K. T., Robert, C., Hersey, P., Nathan, P., Garbe, C., Milhem, M. M., Демидов, Л. В., Hassel, J. C., Rutkowski, P. L., Mohr, P., et al. (2012) · New England Journal of Medicine · doi:10.1056/nejmoa1203421 · Cited by 2,205
Self-citationSurvival in BRAF V600-mutant advanced melanoma treated with vemurafenib
Sosman, J. A., Kim, K. B., Schuchter, L., Gonzalez, R., Pavlick, A. C., Weber, J. S., McArthur, G. A., Hutson, T. E., Moschos, S. J., Flaherty, K. T., et al. (2012) · New England Journal of Medicine · doi:10.1056/nejmoa1112302 · Cited by 2,156
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- 10.1200/JCO.2013.51.4802 · DOI · Paper page
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Hartkopf, A. D., Taran, F., Wallwiener, M., Walter, C. B., Krämer, B., Grischke, E., & Brucker, S. Y. (2016) · Breast Care · doi:10.1159/000453569 · Cited by 30,989
Combined Nivolumab and Ipilimumab or Monotherapy in Untreated Melanoma
Larkin, J., Chiarion-Sileni, V., Gonzalez, R., Grob, J. J., Cowey, C. L., Lao, C. D., Schadendorf, D., Dummer, R., Smylie, M., Rutkowski, P., et al. (2015) · New England Journal of Medicine · doi:10.1056/nejmoa1504030 · Cited by 8,157
Self-citationCancer immunotherapy using checkpoint blockade
Ribas, A., & Wolchok, J. D. (2018) · Science · doi:10.1126/science.aar4060 · Cited by 6,791
Pembrolizumab versus Ipilimumab in Advanced Melanoma
Robert, C., Schachter, J., Long, G. V., Arance, A., Grob, J. J., Mortier, L., Daud, A., Carlino, M. S., McNeil, C., Lotem, M., et al. (2015) · New England Journal of Medicine · doi:10.1056/nejmoa1503093 · Cited by 5,887
Self-citationNivolumab versus Everolimus in Advanced Renal-Cell Carcinoma
Motzer, R. J., Escudier, B., McDermott, D. F., George, S., Hammers, H. J., Srinivas, S., Tykodi, S. S., Sosman, J. A., Procopio, G., Plimack, E. R., et al. (2015) · New England Journal of Medicine · doi:10.1056/nejmoa1510665 · Cited by 5,807
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Metadata
- Authors
- Robert, C., Long, G. V., Brady, B., Dutriaux, C., Maio, M., Mortier, L., Hassel, J. C., Rutkowski, P., McNeil, C., Kalinka-Warzocha, E., Savage, K. J., Hernberg, M. M., Lebbé, C., Charles, J., Mihalcioiu, C., Chiarion-Sileni, V., Mauch, C., Cognetti, F., Arance, A., Schmidt, H., Schadendorf, D., Gogas, H., Lundgren-Eriksson, L., Horak, C., Sharkey, B., Waxman, I. M., Atkinson, V., & Ascierto, P. A.
- Affiliations
- Inserm (FR)
- The University of Sydney (AU)
- Cabrini Hospital (AU)
- Centre Hospitalier Universitaire de Bordeaux (FR)
- University of Siena (IT)
- Hôpital Claude Huriez (FR)
- University Hospital Heidelberg (DE)
- The Maria Sklodowska-Curie National Research Institute of Oncology (PL)
- Royal Prince Alfred Hospital (AU)
- The authors' affiliations are listed in the Appendix.
- BC Cancer Agency (CA)
- Helsinki University Hospital (FI)
- Royal Victoria Hospital (CA)
- Centrum für Integrierte Onkologie (DE)
- Instituto Nazionale Tumori Regina Elena (IT)
- Hospital Clínic de Barcelona (ES)
- Aarhus University Hospital (DK)
- University of Duisburg-Essen (DE)
- National and Kapodistrian University of Athens (GR)
- Bristol-Myers Squibb (United States) (US)
- Greenslopes Private Hospital (AU)
- Istituto Nazionale Tumori IRCCS "Fondazione G. Pascale" (IT)
- ORCID
- Robert, Caroline
- Long, Georgina V.
- Dutriaux, Caroline
- Maio, Michele
- Mortier, Laurent
- Hassel, Jessica C.
- Rutkowski, Piotr
- McNeil, Catriona
- Savage, Kerry J.
- Hernberg, Micaela M.
- Charles, Julie
- Mihalcioiu, Catalin
- Mauch, Cornelia
- Cognetti, Francesco
- Arance, Ana
- Schmidt, Henrik
- Schadendorf, Dirk
- Gogas, Helen
- Atkinson, Victoria
- Ascierto, Paolo A.
- Venue
- New England Journal of Medicine
- Publisher
- Massachusetts Medical Society
- Published
- 2015-01-22
- Volume
- 372
- Issue
- 4
- Pages
- 320-330
- ISSN
- 0028-4793 (ISSN-L)
- 1533-4406
- OpenAlex
- W2128035403
- Semantic Scholar
- 6a8a53c7f9fd79ff959c6101698e58d58ff6123e
- Cited by
- 5,519
- References
- 25
- Citations by year
- 2026: 154 · 2025: 230 · 2024: 293 · 2023: 335 · 2022: 430 · 2021: 516 · 2020: 601 · 2019: 586 · 2018: 642 · 2017: 715 · 2016: 614 · 2015: 373
- FWCI
- 274.51
- Type
- journal article
- Language
- en
- Open access
- bronze
- doi.org
- Locations
- New England Journal of Medicine (publishedVersion)
- PubMed (publishedVersion)
- Kölner Universitäts PublikationsServer (Universität zu Köln) (publishedVersion)
- Use Siena air (University of Siena) (submittedVersion)
- Universitätsbibliographie, Universität Duisburg-Essen (submittedVersion)
- IRIS Research product catalog (Sapienza University of Rome) (submittedVersion)
- Lund University Publications (Lund University) (submittedVersion, other-oa)
- 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
- nivolumab, metastatic melanoma, BRAF wild-type melanoma, dacarbazine, immune checkpoint inhibitors, PD-1 inhibitors, overall survival, progression-free survival, objective response rate, PD-L1 expression, treatment-naive patients, adverse events, immunotherapy versus chemotherapy, subgroup analysis
- MeSH terms
- Nivolumab, Adolescent, Adult, Aged, Aged, 80 and over, Antibodies, Monoclonal, Antineoplastic Agents, Dacarbazine, Double-Blind Method, Female, Humans, Male, Melanoma, Middle Aged, Survival Rate, Disease-Free Survival, Proto-Oncogene Proteins B-raf, Young Adult, Programmed Cell Death 1 Receptor
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