Abstract
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.
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Disclaimers
This plain language summary represents the opinion of the authors. For a full list of declarations, including author disclosure statements, please see the original article. This plain language summary has been developed to accompany the original article and is not intended for any other use.
Financial disclosure
The CheckMate 76K study was sponsored by Bristol Myers Squibb. Support for the development of the original article and this plain language summary were funded by Bristol Myers Squibb.
Writing disclosure
Plain language writing and editorial assistance were provided by Melissa Kirk, PhD and Michele Salernitano of Ashfield MedComms, an Inizio company, and were funded by Bristol Myers Squibb.
Open access
This work is licensed under the Creative Commons Attribution-NonCommercial-NoDerivatives 4.0 Unported License. To view a copy of this license, visit http://creativecommons.org/licenses/by-nc-nd/4.0/
Acknowledgments
The authors of this article thank the people who participated in this study and their families, as well as the investigators, co-investigators, and clinical site staff.