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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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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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