Adjuvant nivolumab in resected stage IIB/C melanoma: primary results from the randomized, phase 3 CheckMate 76K trial
UPMC Health System · UPMC Hillman Cancer Center · +22 more institutions
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Abstract
Patients with resected stage IIB/C melanoma have high recurrence risk, similar to those with resected stage IIIA/B disease. The phase 3, double-blind CheckMate 76K trial assessed 790 patients with resected stage IIB/C melanoma randomized 2:1 (stratified by tumor category) to nivolumab 480 mg or placebo every 4 weeks for 12 months. The primary endpoint was investigator-assessed recurrence-free survival (RFS). Secondary endpoints included distant metastasis-free survival (DMFS) and safety. At 7.8 months of minimum follow-up, nivolumab significantly improved RFS versus placebo (hazard ratio (HR) = 0.42; 95% confidence interval (CI): 0.30-0.59; P
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Authors
21Topics & keywords
Topics
Keywords
- Nivolumab
- Medicine
- Hazard ratio
- Internal medicine
- Placebo
- Clinical endpoint
- Adverse effect
- Adjuvant
UN Sustainable Development Goals
- Good health and well-being
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Funding
- AAmgen
- BSBristol-Myers Squibb
- PPfizer
- AAstraZeneca
- GGlaxoSmithKline
- SSanofi
- MRMelanoma Research Alliance
- ABArray BioPharma
- AAAIM at Melanoma
- RPRegeneron Pharmaceuticals
- JPJazz Pharmaceuticals
- LLLes Laboratories Pierre Fabre
- IIncyte
- OMOncoSec Medical
- NNatera
- EEisai
- ESEuropean Society for Medical Oncology
- OPOno Pharmaceutical
- SPSun Pharma
- IItalfarmaco
- GGenentech