Dapansutrile Plus Pembrolizumab in Melanoma (DREAM)

We are doing this study to find out if the combination of the drugs Dapansutrile and Pembrolizumab is a safe and effective treatment for people with melanoma that does not improve after PD-1 therapy.

Melanoma

Adults ages 18+ who:

• Are diagnosed with stage 3 or stage 4 unresectable melanoma
• Did not respond to previous treatment with anti-PD1 therapy

For more information about who can join this study, please contact the study team at carol.wiggs@duke.edu.

The study is divided into 2 periods: a screening period and a study dosing period.

If you choose to join the study, you will go through a screening period to see if you are eligible. During this period, you will:

• Have a physical exam
• Answer questionnaires
• Have blood draws
• Have imaging scans (X-Ray, MRI, CT, or PET)
• Have a tumor biopsy (only if we do not already have a sample from you)

If you are eligible to proceed to the study dosing period, you will:

• Take Dapansutrile by mouth twice per day.
• Get Pembrolizumab through a vein in your arm (IV) every 3 weeks
• Have physical exams
• Have blood draws
• Give urine samples
• Have regular MRI or CT scans during the study

You will receive the study drugs for up to 2 years unless you have unwanted side effects or the study doctor finds that you are not getting better.