This trial aims to evaluate the safety and effectiveness of pembrolizumab (Keytruda) in stopping cancer coming back, compared to placebo in participants with surgically resected high-risk stage II melanoma. The main outcome that will be measured is how long patients go without cancer coming back (recurrence-free survival).
The details
In patients with melanoma, a common treatment is surgery to remove the tumor. However, in some cases, other treatments are needed to help in preventing cancer recurrence. Pembrolizumab is a common anti-cancer medication. It works by stimulating the immune system to kill cancer cells.
This study wants to find out if pembrolizumab treatment will prevent cancer from coming back. The main outcomes to be measured will be recurrence-free survival, overall survival, and side effects.
Who are they looking for?
This study is looking to recruit approximately 954 patients with surgically resected stage II melanoma. These patients must not have had any other treatment for melanoma apart from surgical resection. There must have been at least 12 weeks since the surgery before the study can start. Patients should have recovered from any side effects from surgery. Female patients of childbearing age must not be pregnant or breastfeeding and should use contraception.
Patients are not eligible for this study if they have another cancer that has required therapy in the last 5 years, if they are diagnosed with a condition that requires treatment with corticosteroids, including organ transplant or if they are recovering from surgery or its complications. Participants must not have received a live vaccine within 30 days prior to the first dose of study treatment or have an active infection that requires treatment. Participants will be excluded if they are enrolled in another study or if they have a mental disorder or any substance abuse.
How will it work
The study will have 2 parts. Participants will be split into two groups. One group will receive up to 17 cycles of pembrolizumab every 3 weeks in the first part. If they experience recurrence, they may be eligible for part 2, where they will receive up to 35 more cycles of pembrolizumab.
The second group will receive up to 17 cycles of placebo. If the disease comes back, these patients may be eligible to start treatment with pembrolizumab for up to 35 cycles. Both pembrolizumab and placebo are administered by intravenous infusion.
The outcomes to be measured are how long until the disease comes back, if at all (recurrence-free survival), survival without cancer spreading, overall survival, and side effects.
