Effectiveness Study of Nivolumab Compared to Placebo in Prevention of Recurrent Melanoma After Complete Resection of Stage IIB/C Melanoma

To join this study, people must have been diagnosed with a specific type of melanoma (Stage IIB or IIC) that has been completely removed by surgery. They must generally be in good health and have no history of the melanoma spreading to their lymph nodes (checked by a sentinel lymph node biopsy, which should have been clear). This study is for people who have not been treated for melanoma before, apart from having the initial cancer surgically removed.

There are also some reasons why someone might not be able to join. This includes if they have had certain other types of melanoma, such as those in the eye or on mucous membranes. Pregnant or breastfeeding women cannot take part. People with active autoimmune diseases (where the immune system attacks the body) or a known allergy to the study medication cannot participate. Also, if someone has previously received certain types of immunotherapy drugs, they would not be eligible for this study.

If you decide to take part in this study, you would receive either the study drug, nivolumab, or a placebo (dummy treatment) for a set period. Both are typically given by infusion into a vein. You would have regular visits to the hospital or clinic for these treatments and for check-ups. These visits will involve physical examinations, blood tests, and scans to monitor your health and to see how the treatment is working. Doctors and nurses will carefully check for any side effects. After finishing the treatment, you would continue to have follow-up appointments to see if the melanoma returns. The total duration of your involvement, including treatment and follow-up, would be fully explained to you before you agree to join.