ArticleClinical cancer research : an official journal of the American Association for Cancer Research2023
Adjuvant Nivolumab versus Ipilimumab in Resected Stage III/IV Melanoma: 5-Year Efficacy and Biomarker Results from CheckMate 238.
Article in Clinical cancer research : an official journal of the American Association for Cancer Research, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 120 papers, 8 of them syntheses that pooled it.
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Who cites it
120 citing papers in PubMed, 8 syntheses or guidelines pooled it, 162 citations in OpenAlex.
- Sex, Timing, and Outcomes of Curative-Intent Immunotherapy: A Systematic Review and Meta-Analysis.JAMA network open · 2026Pooled it
- Real-World Cutaneous Immune-Related Adverse Events of Immunotherapy in Melanoma: A Systematic Review and Meta-Analysis.Dermatology and therapy · 2026Pooled it
- Defining and modeling 'cure' in early-stage melanoma: perspectives from a systematic literature review.Frontiers in oncology · 2026Pooled it
- Prognostic value of C-reactive protein in patients with melanoma: a meta-analysis.Annals of medicine · 2025Pooled it
- A comparison of real-world data on adjuvant treatment in patients with stage III BRAF V600 mutated melanoma - Results of systematic literature research.European journal of cancer (Oxford, England : 1990) · 2025Pooled it
- Cutaneous melanoma: ESMO Clinical Practice Guideline for diagnosis, treatment and follow-up.Annals of oncology : official journal of the European Society for Medical Oncology · 2025Guideline
- SEOM-GEM clinical guidelines for cutaneous melanoma (2023).Clinical & translational oncology : official publication of the Federation of Spanish Oncology Societies and of the National Cancer Institute of Mexico · 2024Guideline
- Efficacy and safety of immune checkpoint inhibitors and targeted therapies in resected melanoma: a systematic review and network meta-analysis.Frontiers in pharmacology · 2023Pooled it
- Phase I/II clinical trial of a melanoma vaccine targeting shared non-mutated antigens and a shared mutated BRAF neoantigen with an agonistic CD40 antibody (CDX-1140) plus TLR3 agonist (poly-ICLC).Journal for immunotherapy of cancer · 2026Trial
- Neoadjuvant ipilimumab plus nivolumab in melanoma: 5-year survival and biomarker analysis from the phase 2 PRADO-trial.Nature medicine · 2026Trial
- Adjuvant nivolumab and relatlimab in stage III/IV melanoma: the randomized phase 3 RELATIVITY-098 trial.Nature medicine · 2025Trial
- BO-112 Plus Pembrolizumab for Patients With Anti-PD-1-Resistant Advanced Melanoma: Phase II Clinical Trial SPOTLIGHT-203.Journal of clinical oncology : official journal of the American Society of Clinical Oncology · 2025Trial
- Pretreatment and on-treatment ctDNA and tissue biomarkers predict recurrence in patients with stage IIIB-D/IV melanoma treated with adjuvant immunotherapy: CheckMate 915.Journal for immunotherapy of cancer · 2025Trial
- Adjuvant dendritic cell-based immunotherapy in melanoma: insights into immune cell dynamics and clinical evidence from a phase II trial.Journal of translational medicine · 2025Trial
- Estimating Long-Term Survivorship Rates Among Patients With Resected Stage III/IV Melanoma: Analyses From CheckMate 238 and European Organization for Research and Treatment of Cancer 18071 Trials.Journal of clinical oncology : official journal of the American Society of Clinical Oncology · 2025Trial
- Outcomes With Postrecurrence Systemic Therapy Following Adjuvant Checkpoint Inhibitor Treatment for Resected Melanoma in CheckMate 238.Journal of clinical oncology : official journal of the American Society of Clinical Oncology · 2024Trial
- Adjuvant nivolumab in resected stage IIB/C melanoma: primary results from the randomized, phase 3 CheckMate 76K trial.Nature medicine · 2023Trial
- Real-World Use of Adjuvant Nivolumab for Resected Stage III-IV Melanoma: 2-Year Analysis of AdjuMel.Dermatology and therapy · 2026Article
- Five-year survival with neoadjuvant therapy in melanoma: updated pooled analysis from the International Neoadjuvant Melanoma Consortium (INMC).Nature medicine · 2026Article
- Review
60 more citing papers are in PubMed but not listed here.
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Authors and funding
31 authors at 20 institutions in 11 countries.
Funding
No grant is acknowledged in the PubMed record.
Abstract
purposeIn the phase III CheckMate 238 study, adjuvant nivolumab significantly improved recurrence-free survival (RFS) and distant metastasis-free survival versus ipilimumab in patients with resected stage IIIB-C or stage IV melanoma, with benefit sustained at 4 years. We report updated 5-year efficacy and biomarker findings. PATIENTS AND
methodsPatients with resected stage IIIB-C/IV melanoma were stratified by stage and baseline programmed death cell ligand 1 (PD-L1) expression and received nivolumab 3 mg/kg every 2 weeks or ipilimumab 10 mg/kg every 3 weeks for four doses and then every 12 weeks, both intravenously for 1 year until disease recurrence, unacceptable toxicity, or withdrawal of consent. The primary endpoint was RFS.
resultsAt a minimum follow-up of 62 months, RFS with nivolumab remained superior to ipilimumab (HR = 0.72; 95% confidence interval, 0.60-0.86; 5-year rates of 50% vs. 39%). Five-year distant metastasis-free survival (DMFS) rates were 58% with nivolumab versus 51% with ipilimumab. Five-year overall survival (OS) rates were 76% with nivolumab and 72% with ipilimumab (75% data maturity: 228 of 302 planned events). Higher levels of tumor mutational burden (TMB), tumor PD-L1, intratumoral CD8+ T cells and IFNγ-associated gene expression signature, and lower levels of peripheral serum C-reactive protein were associated with improved RFS and OS with both nivolumab and ipilimumab, albeit with limited clinically meaningful predictive value.
conclusionsNivolumab is a proven adjuvant treatment for resected melanoma at high risk of recurrence, with sustained, long-term improvement in RFS and DMFS compared with ipilimumab and high OS rates. Identification of additional biomarkers is needed to better predict treatment outcome. See related commentary by Augustin and Luke, p. 3253.
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