WHAT IS THIS SUMMARY ABOUT?: In this article, we summarize results from the ongoing phase 3 CheckMate 76K clinical study published online in Nature Medicine in October 2023. The study goal was to learn whether nivolumab works as an adjuvant therapy (that is, helps to keep cancer from coming back when it is given after surgery) for stage 2 melanoma (skin cancer) that has not spread to other parts of the body. Nivolumab is an immunotherapy that activates a person's immune system so it can destroy cancer cells. In melanoma, staging describes the severity of the cancer. Melanoma staging ranges from 0 (very thin and confined to the upper layer of the skin) to 4 (spread to distant parts of the body), with earlier stages removed by surgery. The people in this study had stage 2 melanoma that had not spread to the lymph nodes or other organs in the body. HOW WAS THE STUDY DESIGNED?: People 12 years and older with stage 2 melanoma that had not spread and had been removed by surgery were included in CheckMate 76K. People were randomly assigned to receive either nivolumab (526 patients) or placebo (264 patients). A placebo resembles the test medicine but does not contain any active medicines. The researchers assessed whether people who received nivolumab lived longer without their cancer returning and/or spreading to other parts of their bodies (compared with placebo) and if nivolumab was well tolerated. WHAT WERE THE RESULTS?: Researchers found that people who received nivolumab were 58% less likely to have their cancer return and 53% less likely of having their cancer spread to distant parts of their body, compared with placebo. These reductions in risk with nivolumab were seen in different subgroups of people with a range of characteristics, and regardless of how deep the melanoma had gone into the skin. People taking nivolumab had more side effects than those taking placebo, but most were mild to moderate and manageable. WHAT DO THE RESULTS MEAN?: Results from CheckMate 76K support the benefit of using nivolumab as a treatment option for people with stage 2 melanoma post-surgery.

Bristol Myers Squibb Princeton NJ USA

Charles University 3rd Faculty of Medicine and University Hospital of Královské Vinohrady Prague Czech Republic

Cleveland Clinic Cleveland OH USA

Elbe Kliniken Buxtehude Buxtehude Germany

Fondazione IRCCS Istituto Nazionale dei Tumori Milan Italy

Hôpital de la Timone Marseille France

Hôpital Saint André Bordeaux France

Institute of Oncology Poznan University of Medical Sciences Poznan Poland

Istituto Nazionale Tumori IRCCS Fondazione G Pascale Naples Italy

Istituto Oncologico Veneto IRCCS Padova Italy

Maria Skłodowska Curie National Research Institute of Oncology Warsaw Poland

Medizinische Universität Wien Vienna Austria

Melanoma Institute Australia University of Sydney and Royal North Shore and Mater Hospitals Sydney NSW Australia

Nantes University Hospital Nantes France

NYU Langone Medical Center New York NY USA

University of Mainz Medical Center Mainz Germany

University of Western Australia and Sir Charles Gairdner Hospital Perth WA Australia

UPMC Hillman Cancer Center Pittsburgh PA USA

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