Posted by on Feb 26, 2019 in Melanoma | 0 comments

In a nutshell

This trial aims to test the effectiveness of pembrolizumab (Keytruda) before and after surgery in patients with high-risk melanoma. The main outcome that will be measured will be survival without cancer-related events.

The details

Pembrolizumab is an anti-cancer medication that targets the immune system. It helps the immune system target and attack cancer cells. It is not known if this treatment will work better if it is performed both before and after surgery.

This trial aims to evaluate the effectiveness of pembrolizumab given before and after surgery in patients with high-risk melanoma. The main outcome that will be measured is disease control and survival.

Who are they looking for?

556 patients with high-risk melanoma that can be surgically removed. Patients must have adequate blood cell counts, liver and kidney function tests. Patients must have a scan of their brain within 42 days of the study.

Patients cannot have infections that are ongoing, including HIV/AIDS and hepatitis. Patients with autoimmune conditions will be excluded. Female patients cannot be pregnant, or planning to get pregnant. They also must use contraception during the study.

How will it work

Patients will be randomly placed into two groups. One group will receive treatment with pembrolizumab on day 1 every 3 weeks for 3 courses. They will then undergo surgery, and continue the treatment with pembrolizumab for 15 more courses. Patients in the other group will receive 18 rounds of treatment with pembrolizumab within 84 days after surgery.

Patients will be followed up to 10 years.

Clinical trial locations

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Type:Interventional
Participants:556
Study ID:NCT03698019
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